Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients

Hyponatremia Clinical Trial

Official title:

Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00727090
• Other study ID #: 1507-10
• Status: Terminated
• Phase: Phase 4
• Start date: August 2008
• Est. completion date: February 2010

Study information

• Verified date: March 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Conivaptan (Vaprisol) is FDA-Approved for the treatment of low serum sodium (hyponatremia), but there are few data in patients with neurologic disease. Very low serum sodium in patients with brain injury can be life-threatening and is associated with cerebral edema (swelling of brain tissue). This can be important in patients with brain hemorrhage, brain tumors, or stroke (cerebral infarction).

This is a pilot study to test the hypothesis that conivaptan (Vaprisol) leads to a greater increase in sodium than usual care. Patients will be randomly assigned to usual care or the lower FDA-approved dose of conivaptan (Vaprisol). We will track the use of other interventions, such as the use of hypertonic saline (concentrated salt solution), diuretics and salt tablets. A blinded co-investigator will record neurologic examination results (NIH Stroke Scale and Glasgow Coma Scale).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• severe hyponatremia (Na < 130 mmol/L) or

• symptomatic hyponatremia - Na < 135 mmol/L for at least six hours with Glasgow Coma Scale < 15

Exclusion Criteria:

• Enrollment in the NMH high-risk spine protocol. These patients receive large amounts of fluids, have rapid changes in electrolytes, and are typically corrected in 48 hours

• Expected death from any cause

• Known sensitivity or allergy to conivaptan

• Renal failure (baseline creatinine > 1.5 mg/dL)

• Clinical diagnosis of hypovolemia, or by central venous pressure (CVP) < 5 mm Hg if a central venous catheter is in place

• Concomitant use of potent inhibitors of cytochrome P-450 isoenzyme 3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir). These agents are not commonly used in the Neuro-ICU

• Clinical diagnosis of liver failure or insufficiency

• Pregnancy (must be excluded before entry)

• Lack of informed consent from the patient or a legally authorized representative (LAR)

• Use of intra-arterial vasodilators (e.g. verapamil, nicardipine) within 24 hours (e.g. for vasospasm after SAH)

• Concern by the Neuro-ICU pharmacist of a drug-drug interaction that would meaningfully impact care (the Neuro-ICU pharmacist will review the medication regimen before recruitment)

• Patients with a diagnosis of diabetes insipidus or treated with vasopressin, since these patients are already treated for abnormal free water balance

• Patients with congestive heart failure, since this is an approved use of the drug (these patients are typically not cared for in the Neuro-ICU)

• Age<18 years (these patients are not cared for at NMH)

• Inclusion declined by the attending physician or consulting study nephrologist

Related Conditions & MeSH terms

• Hyponatremia

Intervention

Drug:
• Conivaptan
Conivaptan 20 mg once, followed by conivaptan 20 mg over 24 hours

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Astellas Pharma US, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Serum Sodium From Baseline to 12 Hours		12 hours
Other	Change in Serum Sodium From Baseline to 18 Hours		18 hours
Other	Change in Serum Sodium From Baseline to 24 Hours		24 hours
Other	Change in Serum Sodium From Baseline to 36 Hours		36 hours
Other	Change in Serum Sodium From Baseline to 48 Hours		48 hours
Primary	Change in Serum Sodium From Baseline to 6 Hours		48 hours
Secondary	NIH Stroke Scale	Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible).	48 hours
Secondary	Glasgow Coma Scale	Standardized examination of mental status ranging from 3 (worst) to 15 (best possible)	48 hours