Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199706
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2005-09-13
Brief Title:
HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
72 NaCl in 6 Hydroxyethyl Starch Versus Placebo - Effect on Intracranial Pressure and Haemodynamics in Subarachnoidal Haemorrhage SAH Patients
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether 72 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S-01264 | None | None | None |