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OpenTrials
Completed

NCT Number: NCT01414894

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

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.

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Key information

About this study

Efficacy of Triple-H therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid manipulation

Other

Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.

Other names: Hypervolemia, Normovolemia

Blood Pressure Manipulation

Other

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

Primary outcomes

  1. 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

    • 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Acronym: IMPROVES

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 11, 2011
Registry last updated
Jun 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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