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

Primary Purpose

Hyponatremia

Status

Terminated

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Conivaptan

About this trial

This is an interventional treatment trial for Hyponatremia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

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

Usual care by the attending physician staff

Outcomes

Primary Outcome Measures

Change in Serum Sodium From Baseline to 6 Hours

Secondary Outcome Measures

NIH Stroke Scale

Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible).

Glasgow Coma Scale

Standardized examination of mental status ranging from 3 (worst) to 15 (best possible)

Full Information

NCT ID

NCT00727090

First Posted

July 30, 2008

Last Updated

March 2, 2022

Sponsor

Northwestern University

Collaborators

Astellas Pharma US, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00727090

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

Enrollment below goal.

Study Start Date

August 2008 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

Astellas Pharma US, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

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

Hyponatremia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

No Intervention

Arm Description

Usual care by the attending physician staff

Intervention Type

Drug

Intervention Name(s)

Conivaptan

Other Intervention Name(s)

Vaprisol

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Serum Sodium From Baseline to 6 Hours

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

NIH Stroke Scale

Description

Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible).

Time Frame

48 hours

Title

Glasgow Coma Scale

Description

Standardized examination of mental status ranging from 3 (worst) to 15 (best possible)

Time Frame

48 hours

Other Pre-specified Outcome Measures:

Title

Change in Serum Sodium From Baseline to 12 Hours

Time Frame

12 hours

Title

Change in Serum Sodium From Baseline to 18 Hours

Time Frame

18 hours

Title

Change in Serum Sodium From Baseline to 24 Hours

Time Frame

24 hours

Title

Change in Serum Sodium From Baseline to 36 Hours

Time Frame

36 hours

Title

Change in Serum Sodium From Baseline to 48 Hours

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew M Naidech, MD, MSPH

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

20568023

Citation

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. Erratum In: Neurocrit Care. 2011 Aug;15(1):210. Leibling, Storm M [corrected to Liebling, Storm M].

Results Reference

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

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