Melatonin in Intensive Therapy Unit (ITU) patients
| ISRCTN | ISRCTN23173759 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23173759 |
| Secondary identifying numbers | N0227109607 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 14/11/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Stephen Bonner
Scientific
Scientific
Cheriton House
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
| Phone | +44 (0)1642 854601 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Can melatonin normalise the sleep pattern in patients who have been on ITU for prolonged periods of time? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous System Diseases: Sleep disorders |
| Intervention | Randomised controlled trial in which melatonin will be given to patients who have ceased to be sedated for their clinical care on ITU, and their physiological and psychological recovery will be recorded. Standard scoring systems are appropriate for this study. |
| Intervention type | Other |
| Primary outcome measure | Time to return to a normal hypnogram and perceived normal pattern of sleep. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2002 |
| Completion date | 31/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | ITU patients who have required prolonged sedation (over 24 h) and who will require further ITU management for some days. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 31/08/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cheriton House
Middlesbrough
TS4 3BW
United Kingdom
TS4 3BW
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
South Tees Hospitals NHS Trust (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 |
