Efficiency of 7.2% hypertonic saline hydroxyethyl starch 200/0.5 versus mannitol 15% in the treatment of increased intracranial pressure in neurosurgical patients

ISRCTN	ISRCTN62699180
DOI	https://doi.org/10.1186/ISRCTN62699180
Protocol serial number	N/A
Sponsor	Martin-Luther-University Halle - Department of Anesthesia and Critical Care (Germany)
Funder	Self-funded trial, Department of Anesthesia and Critical Care, Martin-Luther University Halle (Germany)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jens Soukup
Scientific

Martin-Luther-University Halle
Department of Anaesthesia and Critical Care
Klinikum Kröllwitz
Ernst-Grube-Str. 40
Halle
06097
Germany

Phone	+49 345 5575992
Email	jens.soukup@medizin.uni-halle.de

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Severe brain injury can lead to a brain edema with increased intracranial pressure. This fact leads to a reduced cerebral blood flow and cerebral oxygenation. These situations can extend the brain edema with a possible poor patient outcome. 7.2% hypertonic saline hydroxyethyl starch 200/0.5 is more effective compared to mannitol 15% in the treatment of increased intracranial pressure in neurosurgical patients.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Increased intracranial pressure
Intervention	Cerebral perfusion pressure (CPP) directed therapy with CPP >70 mmHg, sedation, normoventilation. If ICP >20 mmHg patients receive either 7.2% hydroxyethyl starch 200/0.5 or mannitol 15%.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	7.2% hypertonic saline hydroxyethyl starch 200/0.5, mannitol 15%
Primary outcome measure(s)	ICP <15 mmHg
Key secondary outcome measure(s)	Survival, discharge status
Completion date	31/08/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Neurosurgical patients >18 years with severe neuronal damage being at risk of increased intracranial pressure (ICP) 2. Cerebral edema - visualized by computed tomography (CT) scan, continuous monitoring of ICP
Key exclusion criteria	Exclusion criteria were elevated ICP due to space occupying lesions with indication for neurosurgical intervention, severe renal failure, metabolic disorders, initial serum sodium >150 mmol/l and initial serum osmolarity >320 mosm/kg
Date of first enrolment	01/02/2003
Date of final enrolment	31/08/2004

Martin-Luther-University Halle

Halle
06097
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	05/10/2005		Yes	No