Evaluation of melatonin therapy on sleep and delirium in intensive care patients
| ISRCTN | ISRCTN47578325 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47578325 |
| Secondary identifying numbers | N0059122216 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 08/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Richard Bourne
Scientific
Scientific
STH NHS Trust
Critical Care
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
| Phone | +44 (0)114 271 3036 |
|---|---|
| richard.bourne@sth.nhs.uk |
Study information
| Study design | Single centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 1. To evaluate the effect of melatonin therapy on the sleep characteristics of intensive care patients. 2. Secondary objectives include studying the incidence of delirium and bispectral index score between patients receiving melatonin or placebo. |
| Ethics approval(s) | South Sheffield Research Ethics Committee (UK) on 09/01/03. |
| Health condition(s) or problem(s) studied | Nervous System Diseases: Sleep disorders |
| Intervention | Melatonin versus placebo. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | melatonin |
| Primary outcome measure | Sleep and delirium. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/04/2003 |
| Completion date | 30/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 48 |
| Key inclusion criteria | Patients admitted to the adult general intensive care unit with acute respiratory failure requiring mechanical ventilation and then a tracheostomy to assist weaning. |
| Key exclusion criteria | 1. Expected length of stay of less than five further days 2. Previously treated for sleep disturbances 3. Not receiving target enteral feed volume or aspirates greater than 200mls 4. Previous history of convulsions 5. Psychiatric or neurological disease 6. Excessive alcohol consumption (equal to or greater than 50 units per week) 7. Recreational drug use 8. Sleep apnoea 9. Severe heart failure (NYHA III/ IV) 10. Sedative infusions must have been discontinued for more than 24 hours (propofol and alfentanil) or more than 36 hours (morphine and midazolam) with a Sedation Agitation Score (SAS) > 3 |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 30/04/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
STH NHS Trust
Sheffield
S10 2JF
United Kingdom
S10 2JF
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Sheffield Teaching Hospitals - Central Campus (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2008 | Yes | No |
