Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0185139336
Study information
Scientific title
A pilot study of the effect of a hypertonic saline/dextran solution compared to mannitol in the management of raised intracranial pressure
Acronym
Study hypothesis
Whether hypertonic saline/dextran produces greater lowering of raised intracranial pressure and for a longer duration that an equiosmolar dose of mannitol.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Hypertonic Saline/Dextran (HSD) Solution, Mannitol
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2001
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2001
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Plymouth Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary