Subarachnoid Hemorrhage
Conditions
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.
Detailed description
Efficacy of Triple-H therapy.
Interventions
OTHERFluid manipulation
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
OTHERBlood 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.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age more than or equal to 18 years 2. Aneurysmal SAH of any clinical grade 3. Head computed tomography demonstrating SAH 4. Cerebral angiography revealing the presence of cerebral aneurysm(s) in a location that explains the SAH 5. Treatment of aneurysm with clipping or coiling must be carried out prior to randomization and within 72 hours of bleeding 6. Signed consent by study participant or applicable legal representative within 72 hours after SAH
Exclusion criteria
1. History of traumatic SAH 2. Non-aneurysmal SAH as indicated by no demonstrable aneurysm by cerebral angiography 3. 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 4. Delayed referral with clipping/coiling greater than 72 hours after the initial bleeding 5. Time of symptom onset cannot be reliably determined 6. Intracranial hypertension (ICP \>25 mm Hg) at the time of screening 7. 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) 8. Acute, evolving or recent myocardial infarction 9. Cardiac arrhythmia or second and third degree atrio-ventricular block causing hemodynamic instability 10. Chronic renal failure requiring dialysis 11. Suspected or confirmed pregnancy 12. Non English speaking 13. 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 14. Severe terminal disease with life expectancy less than 6 months 15. Refusal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed