Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage

Study Overview
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Brief Summary
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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.

Detailed Description
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Efficacy of Triple-H therapy.

Official Title
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Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage

Conditions
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Subarachnoid Hemorrhage

Intervention / Treatment
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* Other: Fluid manipulation
* Other: Blood Pressure Manipulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Fluids & Normal Blood Pressure<br>Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure). | Other: Fluid manipulation<br>* Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.<br>* Other names: Normovolemia;Other: Blood Pressure Manipulation<br>* 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.<br>* Other names: Augmented Blood Pressure;|
| Active Comparator: Increased Fluids & Normal Blood Pressure<br>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<br>* Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.<br>* Other names: Normovolemia;Other: Blood Pressure Manipulation<br>* 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.<br>* Other names: Augmented Blood Pressure;|
| Active Comparator: Normal Fluids & Higher Blood Pressure<br>Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure). | Other: Fluid manipulation<br>* Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.<br>* Other names: Normovolemia;Other: Blood Pressure Manipulation<br>* 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.<br>* Other names: Augmented Blood Pressure;|
| Active Comparator: Increased Fluids & Higher Blood Pressure<br>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<br>* Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.<br>* Other names: Normovolemia;Other: Blood Pressure Manipulation<br>* 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.<br>* Other names: Augmented Blood Pressure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations. | 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. | 6 months |