The effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial

Background With an ageing population, older persons become a larger part of the hospital population. The incidence of delirium is high in this group, and experiencing delirium has major short- and long-term sequelae, which makes prevention crucial. During delirium, a disruption of the sleep-wake cycle is frequently observed. Melatonin plays an important role in the regulation of the sleep-wake cycle, so this raised the hypothesis that alterations in the metabolism of melatonin might play an important role in the development of delirium. The aim of this article is to describe the design of a randomised, placebo controlled double-blind trial that is currently in progress and that investigates the effects of melatonin versus placebo on delirium in older, postoperative hip fracture patients. Methods/Design Acutely hospitalised patients aged 65 years or older admitted for surgical repair of hip fracture are randomised (n = 452) into a treatment or placebo group. Prophylactic treatment consists of orally administered melatonin (3 mg) at 21:00 h on five consecutive days. The primary outcome is the occurrence of delirium, to be diagnosed according to the Confusion Assessment Method, within eight days after start of the study medication. Secondary outcomes are delirium severity, measured by the Delirium Rating Scale; duration of delirium; differences in subtypes of delirium; differences in total length of hospital stay; total dose of antipsychotics and/or benzodiazepine use during delirium; and in-hospital complications. In the twelve-month follow up visit, cognitive function is measured by a Mini-Mental state examination and the Informant Questionnaire on Cognitive Decline in the Elderly. Functional status is assessed with the Katz ADL index score (patient and family version) and grip strength measurement. The outcomes of these assessments are compared to the outcomes that were obtained during admission. Discussion The proposed study will contribute to our knowledge because studies on the prophylactic treatment of delirium with long term follow up remain scarce. The results may lead to a prophylactic treatment for frail older persons at high risk for delirium that is safe, effective, and easily implementable in daily practice. Trial registration Dutch Clinical Trial Registry: NTR1576 Ausführliche Beschreibung

Gespeichert in:

Autor*in:	de Jonghe, Annemarieke [verfasserIn] van Munster, Barbara C van Oosten, Hannah E Goslings, J Carel Kloen, Peter van Rees, Carolien Wolvius, Reinder van Velde, Romuald Levi, Marcel M Korevaar, Joke C de Rooij, Sophia E

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2011

Schlagwörter:	Melatonin Prophylactic Treatment Melatonin Secretion Melatonin Concentration Safe Treatment Option

Anmerkung:	© de Jonghe et al; licensee BioMed Central Ltd. 2011

Übergeordnetes Werk:	Enthalten in: BMC geriatrics - London : BioMed Central, 2001, 11(2011), 1 vom: 05. Juli
Übergeordnetes Werk:	volume:11 ; year:2011 ; number:1 ; day:05 ; month:07

Links:	Volltext

DOI / URN:	10.1186/1471-2318-11-34

Katalog-ID:	SPR028062558

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allfields	10.1186/1471-2318-11-34 doi (DE-627)SPR028062558 (SPR)1471-2318-11-34-e DE-627 ger DE-627 rakwb eng de Jonghe, Annemarieke verfasserin aut The effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © de Jonghe et al; licensee BioMed Central Ltd. 2011 Background With an ageing population, older persons become a larger part of the hospital population. The incidence of delirium is high in this group, and experiencing delirium has major short- and long-term sequelae, which makes prevention crucial. During delirium, a disruption of the sleep-wake cycle is frequently observed. Melatonin plays an important role in the regulation of the sleep-wake cycle, so this raised the hypothesis that alterations in the metabolism of melatonin might play an important role in the development of delirium. The aim of this article is to describe the design of a randomised, placebo controlled double-blind trial that is currently in progress and that investigates the effects of melatonin versus placebo on delirium in older, postoperative hip fracture patients. Methods/Design Acutely hospitalised patients aged 65 years or older admitted for surgical repair of hip fracture are randomised (n = 452) into a treatment or placebo group. Prophylactic treatment consists of orally administered melatonin (3 mg) at 21:00 h on five consecutive days. The primary outcome is the occurrence of delirium, to be diagnosed according to the Confusion Assessment Method, within eight days after start of the study medication. Secondary outcomes are delirium severity, measured by the Delirium Rating Scale; duration of delirium; differences in subtypes of delirium; differences in total length of hospital stay; total dose of antipsychotics and/or benzodiazepine use during delirium; and in-hospital complications. In the twelve-month follow up visit, cognitive function is measured by a Mini-Mental state examination and the Informant Questionnaire on Cognitive Decline in the Elderly. Functional status is assessed with the Katz ADL index score (patient and family version) and grip strength measurement. The outcomes of these assessments are compared to the outcomes that were obtained during admission. Discussion The proposed study will contribute to our knowledge because studies on the prophylactic treatment of delirium with long term follow up remain scarce. The results may lead to a prophylactic treatment for frail older persons at high risk for delirium that is safe, effective, and easily implementable in daily practice. Trial registration Dutch Clinical Trial Registry: NTR1576 Melatonin (dpeaa)DE-He213 Prophylactic Treatment (dpeaa)DE-He213 Melatonin Secretion (dpeaa)DE-He213 Melatonin Concentration (dpeaa)DE-He213 Safe Treatment Option (dpeaa)DE-He213 van Munster, Barbara C aut van Oosten, Hannah E aut Goslings, J Carel aut Kloen, Peter aut van Rees, Carolien aut Wolvius, Reinder aut van Velde, Romuald aut Levi, Marcel M aut Korevaar, Joke C aut de Rooij, Sophia E aut Enthalten in BMC geriatrics London : BioMed Central, 2001 11(2011), 1 vom: 05. Juli (DE-627)335488994 (DE-600)2059865-8 1471-2318 nnns volume:11 year:2011 number:1 day:05 month:07 https://dx.doi.org/10.1186/1471-2318-11-34 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2011 1 05 07
spelling	10.1186/1471-2318-11-34 doi (DE-627)SPR028062558 (SPR)1471-2318-11-34-e DE-627 ger DE-627 rakwb eng de Jonghe, Annemarieke verfasserin aut The effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © de Jonghe et al; licensee BioMed Central Ltd. 2011 Background With an ageing population, older persons become a larger part of the hospital population. The incidence of delirium is high in this group, and experiencing delirium has major short- and long-term sequelae, which makes prevention crucial. During delirium, a disruption of the sleep-wake cycle is frequently observed. Melatonin plays an important role in the regulation of the sleep-wake cycle, so this raised the hypothesis that alterations in the metabolism of melatonin might play an important role in the development of delirium. The aim of this article is to describe the design of a randomised, placebo controlled double-blind trial that is currently in progress and that investigates the effects of melatonin versus placebo on delirium in older, postoperative hip fracture patients. Methods/Design Acutely hospitalised patients aged 65 years or older admitted for surgical repair of hip fracture are randomised (n = 452) into a treatment or placebo group. Prophylactic treatment consists of orally administered melatonin (3 mg) at 21:00 h on five consecutive days. The primary outcome is the occurrence of delirium, to be diagnosed according to the Confusion Assessment Method, within eight days after start of the study medication. Secondary outcomes are delirium severity, measured by the Delirium Rating Scale; duration of delirium; differences in subtypes of delirium; differences in total length of hospital stay; total dose of antipsychotics and/or benzodiazepine use during delirium; and in-hospital complications. In the twelve-month follow up visit, cognitive function is measured by a Mini-Mental state examination and the Informant Questionnaire on Cognitive Decline in the Elderly. Functional status is assessed with the Katz ADL index score (patient and family version) and grip strength measurement. The outcomes of these assessments are compared to the outcomes that were obtained during admission. Discussion The proposed study will contribute to our knowledge because studies on the prophylactic treatment of delirium with long term follow up remain scarce. The results may lead to a prophylactic treatment for frail older persons at high risk for delirium that is safe, effective, and easily implementable in daily practice. Trial registration Dutch Clinical Trial Registry: NTR1576 Melatonin (dpeaa)DE-He213 Prophylactic Treatment (dpeaa)DE-He213 Melatonin Secretion (dpeaa)DE-He213 Melatonin Concentration (dpeaa)DE-He213 Safe Treatment Option (dpeaa)DE-He213 van Munster, Barbara C aut van Oosten, Hannah E aut Goslings, J Carel aut Kloen, Peter aut van Rees, Carolien aut Wolvius, Reinder aut van Velde, Romuald aut Levi, Marcel M aut Korevaar, Joke C aut de Rooij, Sophia E aut Enthalten in BMC geriatrics London : BioMed Central, 2001 11(2011), 1 vom: 05. Juli (DE-627)335488994 (DE-600)2059865-8 1471-2318 nnns volume:11 year:2011 number:1 day:05 month:07 https://dx.doi.org/10.1186/1471-2318-11-34 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2011 1 05 07
allfields_unstemmed	10.1186/1471-2318-11-34 doi (DE-627)SPR028062558 (SPR)1471-2318-11-34-e DE-627 ger DE-627 rakwb eng de Jonghe, Annemarieke verfasserin aut The effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © de Jonghe et al; licensee BioMed Central Ltd. 2011 Background With an ageing population, older persons become a larger part of the hospital population. The incidence of delirium is high in this group, and experiencing delirium has major short- and long-term sequelae, which makes prevention crucial. During delirium, a disruption of the sleep-wake cycle is frequently observed. Melatonin plays an important role in the regulation of the sleep-wake cycle, so this raised the hypothesis that alterations in the metabolism of melatonin might play an important role in the development of delirium. The aim of this article is to describe the design of a randomised, placebo controlled double-blind trial that is currently in progress and that investigates the effects of melatonin versus placebo on delirium in older, postoperative hip fracture patients. Methods/Design Acutely hospitalised patients aged 65 years or older admitted for surgical repair of hip fracture are randomised (n = 452) into a treatment or placebo group. Prophylactic treatment consists of orally administered melatonin (3 mg) at 21:00 h on five consecutive days. The primary outcome is the occurrence of delirium, to be diagnosed according to the Confusion Assessment Method, within eight days after start of the study medication. Secondary outcomes are delirium severity, measured by the Delirium Rating Scale; duration of delirium; differences in subtypes of delirium; differences in total length of hospital stay; total dose of antipsychotics and/or benzodiazepine use during delirium; and in-hospital complications. In the twelve-month follow up visit, cognitive function is measured by a Mini-Mental state examination and the Informant Questionnaire on Cognitive Decline in the Elderly. Functional status is assessed with the Katz ADL index score (patient and family version) and grip strength measurement. The outcomes of these assessments are compared to the outcomes that were obtained during admission. Discussion The proposed study will contribute to our knowledge because studies on the prophylactic treatment of delirium with long term follow up remain scarce. The results may lead to a prophylactic treatment for frail older persons at high risk for delirium that is safe, effective, and easily implementable in daily practice. Trial registration Dutch Clinical Trial Registry: NTR1576 Melatonin (dpeaa)DE-He213 Prophylactic Treatment (dpeaa)DE-He213 Melatonin Secretion (dpeaa)DE-He213 Melatonin Concentration (dpeaa)DE-He213 Safe Treatment Option (dpeaa)DE-He213 van Munster, Barbara C aut van Oosten, Hannah E aut Goslings, J Carel aut Kloen, Peter aut van Rees, Carolien aut Wolvius, Reinder aut van Velde, Romuald aut Levi, Marcel M aut Korevaar, Joke C aut de Rooij, Sophia E aut Enthalten in BMC geriatrics London : BioMed Central, 2001 11(2011), 1 vom: 05. Juli (DE-627)335488994 (DE-600)2059865-8 1471-2318 nnns volume:11 year:2011 number:1 day:05 month:07 https://dx.doi.org/10.1186/1471-2318-11-34 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2011 1 05 07
allfieldsGer	10.1186/1471-2318-11-34 doi (DE-627)SPR028062558 (SPR)1471-2318-11-34-e DE-627 ger DE-627 rakwb eng de Jonghe, Annemarieke verfasserin aut The effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © de Jonghe et al; licensee BioMed Central Ltd. 2011 Background With an ageing population, older persons become a larger part of the hospital population. The incidence of delirium is high in this group, and experiencing delirium has major short- and long-term sequelae, which makes prevention crucial. During delirium, a disruption of the sleep-wake cycle is frequently observed. Melatonin plays an important role in the regulation of the sleep-wake cycle, so this raised the hypothesis that alterations in the metabolism of melatonin might play an important role in the development of delirium. The aim of this article is to describe the design of a randomised, placebo controlled double-blind trial that is currently in progress and that investigates the effects of melatonin versus placebo on delirium in older, postoperative hip fracture patients. Methods/Design Acutely hospitalised patients aged 65 years or older admitted for surgical repair of hip fracture are randomised (n = 452) into a treatment or placebo group. Prophylactic treatment consists of orally administered melatonin (3 mg) at 21:00 h on five consecutive days. The primary outcome is the occurrence of delirium, to be diagnosed according to the Confusion Assessment Method, within eight days after start of the study medication. Secondary outcomes are delirium severity, measured by the Delirium Rating Scale; duration of delirium; differences in subtypes of delirium; differences in total length of hospital stay; total dose of antipsychotics and/or benzodiazepine use during delirium; and in-hospital complications. In the twelve-month follow up visit, cognitive function is measured by a Mini-Mental state examination and the Informant Questionnaire on Cognitive Decline in the Elderly. Functional status is assessed with the Katz ADL index score (patient and family version) and grip strength measurement. The outcomes of these assessments are compared to the outcomes that were obtained during admission. Discussion The proposed study will contribute to our knowledge because studies on the prophylactic treatment of delirium with long term follow up remain scarce. The results may lead to a prophylactic treatment for frail older persons at high risk for delirium that is safe, effective, and easily implementable in daily practice. Trial registration Dutch Clinical Trial Registry: NTR1576 Melatonin (dpeaa)DE-He213 Prophylactic Treatment (dpeaa)DE-He213 Melatonin Secretion (dpeaa)DE-He213 Melatonin Concentration (dpeaa)DE-He213 Safe Treatment Option (dpeaa)DE-He213 van Munster, Barbara C aut van Oosten, Hannah E aut Goslings, J Carel aut Kloen, Peter aut van Rees, Carolien aut Wolvius, Reinder aut van Velde, Romuald aut Levi, Marcel M aut Korevaar, Joke C aut de Rooij, Sophia E aut Enthalten in BMC geriatrics London : BioMed Central, 2001 11(2011), 1 vom: 05. Juli (DE-627)335488994 (DE-600)2059865-8 1471-2318 nnns volume:11 year:2011 number:1 day:05 month:07 https://dx.doi.org/10.1186/1471-2318-11-34 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2011 1 05 07
allfieldsSound	10.1186/1471-2318-11-34 doi (DE-627)SPR028062558 (SPR)1471-2318-11-34-e DE-627 ger DE-627 rakwb eng de Jonghe, Annemarieke verfasserin aut The effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © de Jonghe et al; licensee BioMed Central Ltd. 2011 Background With an ageing population, older persons become a larger part of the hospital population. The incidence of delirium is high in this group, and experiencing delirium has major short- and long-term sequelae, which makes prevention crucial. During delirium, a disruption of the sleep-wake cycle is frequently observed. Melatonin plays an important role in the regulation of the sleep-wake cycle, so this raised the hypothesis that alterations in the metabolism of melatonin might play an important role in the development of delirium. The aim of this article is to describe the design of a randomised, placebo controlled double-blind trial that is currently in progress and that investigates the effects of melatonin versus placebo on delirium in older, postoperative hip fracture patients. Methods/Design Acutely hospitalised patients aged 65 years or older admitted for surgical repair of hip fracture are randomised (n = 452) into a treatment or placebo group. Prophylactic treatment consists of orally administered melatonin (3 mg) at 21:00 h on five consecutive days. The primary outcome is the occurrence of delirium, to be diagnosed according to the Confusion Assessment Method, within eight days after start of the study medication. Secondary outcomes are delirium severity, measured by the Delirium Rating Scale; duration of delirium; differences in subtypes of delirium; differences in total length of hospital stay; total dose of antipsychotics and/or benzodiazepine use during delirium; and in-hospital complications. In the twelve-month follow up visit, cognitive function is measured by a Mini-Mental state examination and the Informant Questionnaire on Cognitive Decline in the Elderly. Functional status is assessed with the Katz ADL index score (patient and family version) and grip strength measurement. The outcomes of these assessments are compared to the outcomes that were obtained during admission. Discussion The proposed study will contribute to our knowledge because studies on the prophylactic treatment of delirium with long term follow up remain scarce. The results may lead to a prophylactic treatment for frail older persons at high risk for delirium that is safe, effective, and easily implementable in daily practice. Trial registration Dutch Clinical Trial Registry: NTR1576 Melatonin (dpeaa)DE-He213 Prophylactic Treatment (dpeaa)DE-He213 Melatonin Secretion (dpeaa)DE-He213 Melatonin Concentration (dpeaa)DE-He213 Safe Treatment Option (dpeaa)DE-He213 van Munster, Barbara C aut van Oosten, Hannah E aut Goslings, J Carel aut Kloen, Peter aut van Rees, Carolien aut Wolvius, Reinder aut van Velde, Romuald aut Levi, Marcel M aut Korevaar, Joke C aut de Rooij, Sophia E aut Enthalten in BMC geriatrics London : BioMed Central, 2001 11(2011), 1 vom: 05. Juli (DE-627)335488994 (DE-600)2059865-8 1471-2318 nnns volume:11 year:2011 number:1 day:05 month:07 https://dx.doi.org/10.1186/1471-2318-11-34 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2011 1 05 07
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source	Enthalten in BMC geriatrics 11(2011), 1 vom: 05. Juli volume:11 year:2011 number:1 day:05 month:07
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authorswithroles_txt_mv	de Jonghe, Annemarieke @@aut@@ van Munster, Barbara C @@aut@@ van Oosten, Hannah E @@aut@@ Goslings, J Carel @@aut@@ Kloen, Peter @@aut@@ van Rees, Carolien @@aut@@ Wolvius, Reinder @@aut@@ van Velde, Romuald @@aut@@ Levi, Marcel M @@aut@@ Korevaar, Joke C @@aut@@ de Rooij, Sophia E @@aut@@
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The primary outcome is the occurrence of delirium, to be diagnosed according to the Confusion Assessment Method, within eight days after start of the study medication. Secondary outcomes are delirium severity, measured by the Delirium Rating Scale; duration of delirium; differences in subtypes of delirium; differences in total length of hospital stay; total dose of antipsychotics and/or benzodiazepine use during delirium; and in-hospital complications. In the twelve-month follow up visit, cognitive function is measured by a Mini-Mental state examination and the Informant Questionnaire on Cognitive Decline in the Elderly. Functional status is assessed with the Katz ADL index score (patient and family version) and grip strength measurement. The outcomes of these assessments are compared to the outcomes that were obtained during admission. 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topic_title	The effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial Melatonin (dpeaa)DE-He213 Prophylactic Treatment (dpeaa)DE-He213 Melatonin Secretion (dpeaa)DE-He213 Melatonin Concentration (dpeaa)DE-He213 Safe Treatment Option (dpeaa)DE-He213
topic	misc Melatonin misc Prophylactic Treatment misc Melatonin Secretion misc Melatonin Concentration misc Safe Treatment Option
topic_unstemmed	misc Melatonin misc Prophylactic Treatment misc Melatonin Secretion misc Melatonin Concentration misc Safe Treatment Option
topic_browse	misc Melatonin misc Prophylactic Treatment misc Melatonin Secretion misc Melatonin Concentration misc Safe Treatment Option
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title	The effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial
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title_full	The effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial
author_sort	de Jonghe, Annemarieke
journal	BMC geriatrics
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author_browse	de Jonghe, Annemarieke van Munster, Barbara C van Oosten, Hannah E Goslings, J Carel Kloen, Peter van Rees, Carolien Wolvius, Reinder van Velde, Romuald Levi, Marcel M Korevaar, Joke C de Rooij, Sophia E
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author-letter	de Jonghe, Annemarieke
doi_str_mv	10.1186/1471-2318-11-34
title_sort	effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial
title_auth	The effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial
abstract	Background With an ageing population, older persons become a larger part of the hospital population. The incidence of delirium is high in this group, and experiencing delirium has major short- and long-term sequelae, which makes prevention crucial. During delirium, a disruption of the sleep-wake cycle is frequently observed. Melatonin plays an important role in the regulation of the sleep-wake cycle, so this raised the hypothesis that alterations in the metabolism of melatonin might play an important role in the development of delirium. The aim of this article is to describe the design of a randomised, placebo controlled double-blind trial that is currently in progress and that investigates the effects of melatonin versus placebo on delirium in older, postoperative hip fracture patients. Methods/Design Acutely hospitalised patients aged 65 years or older admitted for surgical repair of hip fracture are randomised (n = 452) into a treatment or placebo group. Prophylactic treatment consists of orally administered melatonin (3 mg) at 21:00 h on five consecutive days. The primary outcome is the occurrence of delirium, to be diagnosed according to the Confusion Assessment Method, within eight days after start of the study medication. Secondary outcomes are delirium severity, measured by the Delirium Rating Scale; duration of delirium; differences in subtypes of delirium; differences in total length of hospital stay; total dose of antipsychotics and/or benzodiazepine use during delirium; and in-hospital complications. In the twelve-month follow up visit, cognitive function is measured by a Mini-Mental state examination and the Informant Questionnaire on Cognitive Decline in the Elderly. Functional status is assessed with the Katz ADL index score (patient and family version) and grip strength measurement. The outcomes of these assessments are compared to the outcomes that were obtained during admission. Discussion The proposed study will contribute to our knowledge because studies on the prophylactic treatment of delirium with long term follow up remain scarce. The results may lead to a prophylactic treatment for frail older persons at high risk for delirium that is safe, effective, and easily implementable in daily practice. Trial registration Dutch Clinical Trial Registry: NTR1576 © de Jonghe et al; licensee BioMed Central Ltd. 2011
abstractGer	Background With an ageing population, older persons become a larger part of the hospital population. The incidence of delirium is high in this group, and experiencing delirium has major short- and long-term sequelae, which makes prevention crucial. During delirium, a disruption of the sleep-wake cycle is frequently observed. Melatonin plays an important role in the regulation of the sleep-wake cycle, so this raised the hypothesis that alterations in the metabolism of melatonin might play an important role in the development of delirium. The aim of this article is to describe the design of a randomised, placebo controlled double-blind trial that is currently in progress and that investigates the effects of melatonin versus placebo on delirium in older, postoperative hip fracture patients. Methods/Design Acutely hospitalised patients aged 65 years or older admitted for surgical repair of hip fracture are randomised (n = 452) into a treatment or placebo group. Prophylactic treatment consists of orally administered melatonin (3 mg) at 21:00 h on five consecutive days. The primary outcome is the occurrence of delirium, to be diagnosed according to the Confusion Assessment Method, within eight days after start of the study medication. Secondary outcomes are delirium severity, measured by the Delirium Rating Scale; duration of delirium; differences in subtypes of delirium; differences in total length of hospital stay; total dose of antipsychotics and/or benzodiazepine use during delirium; and in-hospital complications. In the twelve-month follow up visit, cognitive function is measured by a Mini-Mental state examination and the Informant Questionnaire on Cognitive Decline in the Elderly. Functional status is assessed with the Katz ADL index score (patient and family version) and grip strength measurement. The outcomes of these assessments are compared to the outcomes that were obtained during admission. Discussion The proposed study will contribute to our knowledge because studies on the prophylactic treatment of delirium with long term follow up remain scarce. The results may lead to a prophylactic treatment for frail older persons at high risk for delirium that is safe, effective, and easily implementable in daily practice. Trial registration Dutch Clinical Trial Registry: NTR1576 © de Jonghe et al; licensee BioMed Central Ltd. 2011
abstract_unstemmed	Background With an ageing population, older persons become a larger part of the hospital population. The incidence of delirium is high in this group, and experiencing delirium has major short- and long-term sequelae, which makes prevention crucial. During delirium, a disruption of the sleep-wake cycle is frequently observed. Melatonin plays an important role in the regulation of the sleep-wake cycle, so this raised the hypothesis that alterations in the metabolism of melatonin might play an important role in the development of delirium. The aim of this article is to describe the design of a randomised, placebo controlled double-blind trial that is currently in progress and that investigates the effects of melatonin versus placebo on delirium in older, postoperative hip fracture patients. Methods/Design Acutely hospitalised patients aged 65 years or older admitted for surgical repair of hip fracture are randomised (n = 452) into a treatment or placebo group. Prophylactic treatment consists of orally administered melatonin (3 mg) at 21:00 h on five consecutive days. The primary outcome is the occurrence of delirium, to be diagnosed according to the Confusion Assessment Method, within eight days after start of the study medication. Secondary outcomes are delirium severity, measured by the Delirium Rating Scale; duration of delirium; differences in subtypes of delirium; differences in total length of hospital stay; total dose of antipsychotics and/or benzodiazepine use during delirium; and in-hospital complications. In the twelve-month follow up visit, cognitive function is measured by a Mini-Mental state examination and the Informant Questionnaire on Cognitive Decline in the Elderly. Functional status is assessed with the Katz ADL index score (patient and family version) and grip strength measurement. The outcomes of these assessments are compared to the outcomes that were obtained during admission. Discussion The proposed study will contribute to our knowledge because studies on the prophylactic treatment of delirium with long term follow up remain scarce. The results may lead to a prophylactic treatment for frail older persons at high risk for delirium that is safe, effective, and easily implementable in daily practice. Trial registration Dutch Clinical Trial Registry: NTR1576 © de Jonghe et al; licensee BioMed Central Ltd. 2011
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title_short	The effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial
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author2	van Munster, Barbara C van Oosten, Hannah E Goslings, J Carel Kloen, Peter van Rees, Carolien Wolvius, Reinder van Velde, Romuald Levi, Marcel M Korevaar, Joke C de Rooij, Sophia E
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