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

NCT00727090 | Terminated Phase 4 Results

• 1 other identifier: 1507-10
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Hyponatremia

Outcome Measures

Primary Outcomes (1)

• Change in Serum Sodium From Baseline to 6 Hours

  48 hours

Secondary Outcomes (2)

• NIH Stroke Scale

  48 hours

• Glasgow Coma Scale

  48 hours

Other Outcomes (5)

• Change in Serum Sodium From Baseline to 12 Hours

  12 hours

• Change in Serum Sodium From Baseline to 18 Hours

  18 hours

• Change in Serum Sodium From Baseline to 24 Hours

  24 hours

Study Arms (2)

1

EXPERIMENTAL

Conivaptan in addition to usual care at the discretion of the attending medical staff

Drug: Conivaptan

2

NO INTERVENTION

Usual care by the attending physician staff

Interventions

Conivaptan DRUG

Conivaptan 20 mg once, followed by conivaptan 20 mg over 24 hours

Also known as: Vaprisol

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• severe hyponatremia (Na \< 130 mmol/L) or
• symptomatic hyponatremia - Na \< 135 mmol/L for at least six hours with Glasgow Coma Scale \< 15

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwestern University: lead
• Astellas Pharma US, Inc.: collaborator

Related Publications (1)

• Naidech AM, Paparello J, Liebling SM, Bassin SL, Levasseur K, Alberts MJ, Bernstein RA, Muro K. Use of Conivaptan (Vaprisol) for hyponatremic neuro-ICU patients. Neurocrit Care. 2010 Aug;13(1):57-61. doi: 10.1007/s12028-010-9379-5.

  PMID: 20568023 DERIVED

MeSH Terms

Conditions

Hyponatremia

Interventions

conivaptan

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Andrew M Naidech
• Organization: Northwestern University

a-naidech@northwestern.edu

312-503-3592

Study Officials

• Andrew M Naidech, MD, MSPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 1, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 28, 2022
• Results First Posted: September 27, 2010

Record last verified: 2022-03