HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients

NCT ID: NCT00199706

Last Updated: 2011-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2004-10-31

Brief Summary

The purpose of this study is to determine whether 7.2% NaCl in 6% hydroxyethyl starch will lower intracranial pressure (ICP) in SAH-patients with normal or moderately elevated ICP in a placebo controlled study, and to describe the haemodynamic effects.

Detailed Description

In the acute phase after a SAH, many patients need intensive care treatment to control the development of fatally increased intracranial pressure. One type of treatment used is osmotherapy. Traditionally mannitol has been the preferred drug, but the use of hypertonic saline solutions has gained more and more acceptance. The immediate effect seems to be equivalent or better than with mannitol, and there seem to be less adverse effects, such as hypovolemia, acute renal failure, hyponatremia, and rebound increase of ICP.

Most clinical studies in patients with life-threatening increase in ICP are observational, and show a predictable effect of hypertonic saline. We wanted to strengthen our own findings from such a study by applying the same study model but with a placebo control group in patients with only moderately elevated ICP.

We also wanted to document the haemodynamic effects, measuring cardiac output, intrathorasic blood volume and extravascular lung water.

Conditions

Subarachnoid Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

7.2% NaCl in 6% hydroxyethyl starch solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subarachnoid Hemorrhage, source of bleeding radiologically or surgically secured
• Age > 18 years
• Mechanically ventilated
• Sedated
• Stable hemodynamics
• Stable intracranial pressure between 10 - 20 mmHg

Exclusion Criteria

• Serum sodium > 160 mmol/l

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Gunnar Bentsen, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Other Identifiers

S-01264

Identifier Type: -

Identifier Source: secondary_id

2002-SAHA

Identifier Type: -

Identifier Source: org_study_id