Subarachnoid HemorrhagePhase 2NCT00199706
HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients
A Phase 2 study testing 7.2% NaCl in 6% hydroxyethyl starch solution in people with Subarachnoid Hemorrhage, run by Oslo University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- 7.2% NaCl in 6% hydroxyethyl starch solution
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Oct 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subarachnoid Hemorrhage, source of bleeding radiologically or surgically secured
- Age > 18 years
- Mechanically ventilated
- Sedated
- Stable hemodynamics
- Stable intracranial pressure between 10 - 20 mmHg
Who cannot join
- Serum sodium > 160 mmol/l
About this study
Official title: 7.2% NaCl in 6% Hydroxyethyl Starch Versus Placebo - Effect on Intracranial Pressure and Haemodynamics in Subarachnoidal Haemorrhage (SAH) Patients.
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.
Read the 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
- Being tested
- 7.2% NaCl in 6% hydroxyethyl starch solution
- Keywords
- Intracranial Pressure, Intracranial Hypertension, Hypertonic Solutions, Saline Solutions, Hypertonic
- Medical subject headings
- Subarachnoid Hemorrhage, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7.2% NaCl in 6% hydroxyethyl starch solutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2002
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Gunnar Bentsen, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199706
- Sponsor's protocol ID
- 2002-SAHA
- Other IDs
- S-01264
- Status last verified
- Nov 2005
- First submitted
- 13 Sep 2005
- Last updated
- 1 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7.2% NaCl in 6% Hydroxyethyl Starch Versus Placebo - Effect on Intracranial Pressure and Haemodynamics in Subarachnoidal Haemorrhage (SAH) Patients.
- ClinicalTrials.gov ID
- NCT00199706
- Acronym / sponsor ID
- 2002-SAHA
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Intracranial Pressure, Intracranial Hypertension, Hypertonic Solutions, Saline Solutions, Hypertonic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Apr 2002
- Study completion
- Oct 2004
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subarachnoid Hemorrhage, source of bleeding radiologically or surgically secured
- Age > 18 years
- Mechanically ventilated
- Sedated
- Stable hemodynamics
Key exclusion criteria (1 listed)
- Serum sodium > 160 mmol/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7.2% NaCl in 6% hydroxyethyl starch solution | Drug | – |
Primary outcome
Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Bentsen, MD principal investigator
Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 7.2% NaCl in 6% hydroxyethyl starch solution in people with Subarachnoid Hemorrhage, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2011.