Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury

NCT ID: NCT00930202

Last Updated: 2010-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-06-30

Brief Summary

The investigators plan to utilize conivaptan (Vaprisol) to promote isolated water loss, in combination with normal (physiologic) fluid replacement to maintain a normal blood volume status, in patients with severe TBI. The goal of this therapy is to raise blood sodium in a controlled fashion in subjects with severe TBI, and reduce the use of hypertonic saline infusion. We hypothesize that this therapy will maintain a stable state of high blood sodium, while decreasing the overall sodium load needed to achieve these goals.

Conditions

Severe Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conivaptan (Vaprisol)

Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes.

Group Type: EXPERIMENTAL

Conivaptan (Vaprisol)

Intervention Type: DRUG

Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes.

Standard Care

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Conivaptan (Vaprisol)

Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years old or greater
• Initial diagnosis of an isolated, severe traumatic brain injury (Glasgow Coma Score of 8 or less upon initial evaluation)
• Cerebral edema with a head CT and Marshall classification of diffuse injury type II, III, or IV.
• Primary care team orders to raise blood sodium by 10 mEq/L from baseline.
• Placement of an intraparenchymal fiberoptic monitor to monitor intracranial pressure (ICP).

Exclusion Criteria

• Age < 18 years
• Signs of hypovolemia including systolic BP < 90 mmHg
• Signs of liver disease including jaundice and ascites

• AST > 35 units/L
• ALT > 35 units/L
• Signs of renal disease including history of dialysis

• Serum creatinine > 1.5 mg/dL
• BUN > 20 mg/dL range
• Baseline serum sodium >/= 145 mEq/L
• Pregnant or lactating females
• Concomitant use of digoxin, ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, simvastatin and lovastatin
• Presentation to the tertiary care hospital > 24 hours post-injury
• Multi-system traumatic injuries
• Diabetes Insipidus
• Anticipation of diagnosis compatible with brain death, or no expectation of survival with 48 hours.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

University of Washington

Principal Investigators

Miriam Treggiari, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

35774-A

Identifier Type: -

Identifier Source: org_study_id