A pilot study of the effect of a hypertonic saline/dextran solution compared to mannitol in the management of raised intracranial pressure
| ISRCTN | ISRCTN82121210 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82121210 |
| Protocol serial number | N0185139336 |
| Sponsor | Department of Health |
| Funder | Plymouth Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 13/04/2018
- 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 P D Macnaughton
Scientific
Scientific
Intensive Care Unit
Level 04
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A pilot study of the effect of a hypertonic saline/dextran solution compared to mannitol in the management of raised intracranial pressure |
| Study objectives | Whether hypertonic saline/dextran produces greater lowering of raised intracranial pressure and for a longer duration that an equiosmolar dose of mannitol. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous System Diseases: Raised Intracranial Pressure (ICP) |
| Intervention | Patients on the intensive care unit with brain injury and an intracranial monitor fitted will be eligible for entry into the study. Those with persistently elevated ICP despite usual management will be randomised to receive either mannitol 0.25 g/kg (the standard treatment at this point) or an equiosmolar dose of HSD. ICP will be recorded each minute using the standard ICU monitors. Patients will be eligible to receive up to three doses of the drug (Mannitol or HSD) if their clinical condition warrants it and there are no contra-indications. ICP will be monitored, for the purposes of the study, until eight hours since the last dose of HSD/mannitol. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hypertonic Saline/Dextran (HSD) Solution, Mannitol |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| 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 | 01/11/2001 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/04/2018: No publications found, verifying study status with principal investigator.
31/03/2016: No publications found, verifying study status with principal investigator
