| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN82121210 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0185139336 |
| Public title | A Pilot Study of the Effect of a Hypertonic Saline/Dextran (HSD) Solution Compared to Mannitol in the Management of Raised Intracranial Pressure (ICP) |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Injury, Occupational Diseases, Poisoning: Brain |
| Study hypothesis | Whether hypertonic saline/dextran produces greater lowering of raised intracranial pressure and for a longer duration that an equiosmolar dose of mannitol. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Not provided at time of registration |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/11/2001 |
| Anticipated end date | 31/12/2004 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Plymouth Hospitals NHS Trust |
| Sponsor name | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr P D Macnaughton |
| Contact details | Intensive Care Unit,
Level 04
Derriford Hospital
Derriford
Plymouth
United Kingdom
PL6 8DH |
| Contact telephone | +44 (0)1752 792555 |
| Contact fax | +44 (0)1752 763287 |
| Contact email | peter.macnaughton@phnt.swest.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN82121210 |
| Date last extracted from ISRCTN register | 17/04/2008 |
