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

Primary Purpose

Subarachnoid Hemorrhage

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Fluid manipulation

Blood Pressure Manipulation

About this trial

This is an interventional prevention trial for Subarachnoid Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Normal Fluids & Normal Blood Pressure

Increased Fluids & Normal Blood Pressure

Normal Fluids & Higher Blood Pressure

Increased Fluids & Higher Blood Pressure

Arm Description

Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a normal range (Conventional 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)

Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a higher range (Augmented 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).

Outcomes

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01414894

First Posted

April 5, 2010

Last Updated

June 18, 2013

Sponsor

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT01414894

Brief Title

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

Acronym

IMPROVES

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subarachnoid Hemorrhage

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal Fluids & Normal Blood Pressure

Arm Type

Active Comparator

Arm Description

Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure).

Arm Title

Increased Fluids & Normal Blood Pressure

Arm Type

Active Comparator

Arm Description

Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure)

Arm Title

Normal Fluids & Higher Blood Pressure

Arm Type

Active Comparator

Arm Description

Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure).

Arm Title

Increased Fluids & Higher Blood Pressure

Arm Type

Active Comparator

Arm Description

Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure).

Intervention Type

Other

Intervention Name(s)

Fluid manipulation

Other Intervention Name(s)

Hypervolemia, Normovolemia

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Blood Pressure Manipulation

Other Intervention Name(s)

Conventional Blood Pressure, Augmented Blood Pressure

Intervention Description

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.

Primary Outcome Measure Information:

Title

Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations.

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miriam Treggiari, MD, PhH, MPH

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

25549192

Citation

Togashi K, Joffe AM, Sekhar L, Kim L, Lam A, Yanez D, Broeckel-Elrod JA, Moore A, Deem S, Khandelwal N, Souter MJ, Treggiari MM. Randomized pilot trial of intensive management of blood pressure or volume expansion in subarachnoid hemorrhage (IMPROVES). Neurosurgery. 2015 Feb;76(2):125-34; discussion 134-5; quiz 135. doi: 10.1227/NEU.0000000000000592.

Results Reference

derived

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

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