IMPROVES: Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage
Study Details
Study Description
Brief Summary
The purpose of our study is to determine how well Triple-H works and how safe it is. The investigators are hoping to determine the effects of starting the therapy early and to explore if hypervolemia and/or hypertension are beneficial, and what the optimal target ranges are.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Efficacy of Triple-H therapy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Normal Fluids & Normal Blood Pressure Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure). |
Other: Fluid manipulation
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Other Names:
Other: Blood Pressure Manipulation
Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
Other Names:
|
| Active Comparator: Increased Fluids & Normal Blood Pressure Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure) |
Other: Fluid manipulation
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Other Names:
Other: Blood Pressure Manipulation
Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
Other Names:
|
| Active Comparator: Normal Fluids & Higher Blood Pressure Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure). |
Other: Fluid manipulation
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Other Names:
Other: Blood Pressure Manipulation
Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
Other Names:
|
| Active Comparator: Increased Fluids & Higher Blood Pressure Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure). |
Other: Fluid manipulation
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Other Names:
Other: Blood Pressure Manipulation
Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations. [6 months]
1. Estimation of the eligible population once specific study inclusion & exclusion criteria are applied 2. Estimation of enrollment projections, retention, attrition & losses to follow up; 3. Assessment of compliance with protocol instructions; 4. Evaluation of protocol violations; 5. Achievement of pre-determined hemodynamic goals in each study group.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age more than or equal to 18 years
-
Aneurysmal SAH of any clinical grade
-
Head computed tomography demonstrating SAH
-
Cerebral angiography revealing the presence of cerebral aneurysm(s) in a location that explains the SAH
-
Treatment of aneurysm with clipping or coiling must be carried out prior to randomization and within 72 hours of bleeding
-
Signed consent by study participant or applicable legal representative within 72 hours after SAH
Exclusion Criteria:
-
History of traumatic SAH
-
Non-aneurysmal SAH as indicated by no demonstrable aneurysm by cerebral angiography
-
Presence of an unsecured intracranial aneurysm(s) at risk of rupture that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
-
Delayed referral with clipping/coiling greater than 72 hours after the initial bleeding
-
Time of symptom onset cannot be reliably determined
-
Intracranial hypertension (ICP >25 mm Hg) at the time of screening
-
History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D)
-
Acute, evolving or recent myocardial infarction
-
Cardiac arrhythmia or second and third degree atrio-ventricular block causing hemodynamic instability
-
Chronic renal failure requiring dialysis
-
Suspected or confirmed pregnancy
-
Non English speaking
-
A condition that would preclude the performance of the neurobehavioral test battery due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation
-
Severe terminal disease with life expectancy less than 6 months
-
Refusal of consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Washington
Investigators
- Principal Investigator: Miriam Treggiari, MD, PhH, MPH, University of Washington
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 37222-A