Condition category
Nervous System Diseases
Date applied
23/06/2005
Date assigned
24/06/2005
Last edited
15/04/2008
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 Jens Soukup

ORCID ID

Contact details

Martin-Luther-University Halle
Department of Anaesthesia and Critical Care
Klinikum Kröllwitz
Ernst-Grube-Str. 40
Halle
06097
Germany
+49 345 5575992
jens.soukup@medizin.uni-halle.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

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

Condition

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 names

7.2% hypertonic saline hydroxyethyl starch 200/0.5, mannitol 15%

Primary outcome measures

ICP <15 mmHg

Secondary outcome measures

Survival, discharge status

Overall trial start date

01/02/2003

Overall trial end date

31/08/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/02/2003

Recruitment end date

31/08/2004

Locations

Countries of recruitment

Germany

Trial participating centre

Martin-Luther-University Halle
Halle
06097
Germany

Sponsor information

Organisation

Martin-Luther-University Halle - Department of Anesthesia and Critical Care (Germany)

Sponsor details

Klinikum Kröllwitz
Ernst-Grube-Str. 40
Halle
06097
Germany
+49 345 5575992
jens.soukup@medizin.uni-halle.de

Sponsor type

University/education

Website

http://www.experimentelle-anaesthesie.de

Funders

Funder type

University/education

Funder name

Self-funded trial, Department of Anesthesia and Critical Care, Martin-Luther University Halle (Germany)

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

Results: http://www.ncbi.nlm.nih.gov/pubmed/16277715

Publication citations

  1. Results

    Harutjunyan L, Holz C, Rieger A, Menzel M, Grond S, Soukup J, Efficiency of 7.2% hypertonic saline hydroxyethyl starch 200/0.5 versus mannitol 15% in the treatment of increased intracranial pressure in neurosurgical patients - a randomized clinical trial [ISRCTN62699180]., Crit Care, 2005, 9, 5, R530-40, doi: 10.1186/cc3767.

Additional files

Editorial Notes