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

This study is currently recruiting participants.
Verified August 2011 by University of Washington
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01414894
First received: April 5, 2010
Last updated: August 10, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Subarachnoid Hemorrhage
 Other: Fluid manipulation
Other: Blood Pressure Manipulation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Hypervolemia
  • Normovolemia
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:
  • Conventional Blood Pressure
  • Augmented Blood Pressure
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:
  • Hypervolemia
  • Normovolemia
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:
  • Conventional Blood Pressure
  • Augmented Blood Pressure
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:
  • Hypervolemia
  • Normovolemia
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:
  • Conventional Blood Pressure
  • Augmented Blood Pressure
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:
  • Hypervolemia
  • Normovolemia
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:
  • Conventional Blood Pressure
  • Augmented Blood Pressure

Detailed Description:

Efficacy of Triple-H therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414894

Contacts
Contact: Miriam Treggiari, MD 206-744-3059 treggmm@u.washington.edu
Contact: Laura Sissons-Ross 206-744-5992 lsissons@uw.edu

Locations
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Principal Investigator: Miriam Treggiari, MD            
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Miriam Treggiari, MD, PhH, MPH University of Washington
  More Information

No publications provided

Responsible Party: Miriam Treggiari, University of Washington
ClinicalTrials.gov Identifier: NCT01414894     History of Changes
Other Study ID Numbers: 37222-A
Study First Received: April 5, 2010
Last Updated: August 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013