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

Subarachnoid Hemorrhage Clinical Trial

— IMPROVES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414894
• Other study ID #: 37222-A
• Status: Completed
• Phase: Phase 1
• First received: April 5, 2010
• Last updated: June 18, 2013
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Efficacy of Triple-H therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Other:
• Fluid manipulation
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No