A multicentre randomised controlled trial of mild hypothermia for the prevention of intracranial hypertension in acute liver failure
| ISRCTN | ISRCTN74268282 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74268282 |
| Protocol serial number | N0116169596 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK) |
| Funders | Kings College Hospital NHS Trust R&D Consortium, Own Account, NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 15/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Will Bernal
Scientific
Scientific
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
| Phone | +44 020 7737 4000xt 4458 |
|---|---|
| william.bernal@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A multicentre randomised controlled trial of mild hypothermia for the prevention of intracranial hypertension in acute liver failure |
| Study objectives | The aim of this study is to to establish what temperature is of greatest benefit to patients in preventing the development of cerebral oedema (CO). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive System: Acute liver failure (ALF) |
| Intervention | Randomised controlled trial |
| Intervention type | Other |
| Primary outcome measure(s) | Onset of ICH, development of a sustained rise of ICP (>5 minutes of ICP > 25 mmHb) |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 01/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 01/11/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
King's College Hospital
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/08/2016 | Yes | No |
Editorial Notes
15/03/2017: No publications found in PubMed, verifying study status with principal investigator
