Condition category
Nervous System Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
31/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P D Macnaughton

ORCID ID

Contact details

Intensive Care Unit
Level 04
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom
+44 (0)1752 792555
peter.macnaughton@phnt.swest.nhs.uk

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

31/03/2016: No publications found, verifying study status with principal investigator