NCT00199706

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

July 1, 2011

Status Verified

November 1, 2005

First QC Date

September 13, 2005

Last Update Submit

June 30, 2011

Conditions

Subarachnoid Hemorrhage

Keywords

Intracranial PressureIntracranial HypertensionHypertonic SolutionsSaline Solutions, Hypertonic

Outcome Measures

Primary Outcomes (1)

  • Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period

Secondary Outcomes (5)

  • Changes in cerebral perfusion pressure (CPP) measured as AUC

  • changes in cardiac output

  • intrathorasic blood volume

  • extravascular lung water

  • serum sodium levels during the 210 minutes trial period

Interventions

7.2% NaCl in 6% hydroxyethyl starch solutionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- Serum sodium \> 160 mmol/l

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Subarachnoid HemorrhageIntracranial Hypertension

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gunnar Bentsen, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

April 1, 2002

Study Completion

October 1, 2004

Last Updated

July 1, 2011

Record last verified: 2005-11