Health Condition 1: null- Euvolemic or hypervolemic hyponatremia Health Condition 2: E871- Hypo-osmolality and hyponatremia
Conditions
Interventions
Intervention1: Conivaptan hydrochloride (20mg/4ml ampule) injection: Loading dose of 20 mg IV administered over 30 minutes followed by 20 mg of Conivaptan hydrochloride administered in a continuous in
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either sex more than or equal to 18 years of age. 2.Patients with established diagnosis of euvolemic or hypervolemic hyponatremia with serum sodium levels less than or equal to 130 mEq/L. 3.Informed consent of the patient / relative.
Exclusion criteria
Exclusion criteria: 1.Pregnancy and/or Lactation. 2.Patients with significant orthostatic hypotension or supine systolic blood pressure less than 90 mm of Hg. 3.Patients with uncontrolled hypertension, cardiac arrhythmias or diabetes mellitus. 4.Patients with moderate to severe hepatic and /or renal dysfunction. 5.Patients with known hypersensitivity to Conivaptan hydrochloride or any of the components of the study medication. 6.Patients with any other serious concurrent illness or malignancy. 7.Patients with continuing history of alcohol and / or drug abuse. 8.Participation in another clinical trial in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of change in serum sodium level at end of treatment phase, as compared to start of treatment phase i.e., Day 0Timepoint: 1,2,3 & 4 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The percentage of patients achieving eunatremia at the end of treatment phase, as compared to baseline i.e., Day 0. 2.The change in serum sodium level as assessed serially every 12 hourly during the entire study period.Timepoint: 1,2,3 & 4 days | — |
Countries
India
Contacts
Public ContactDr Amit Kubavat
Cadila Healthcare Ltd.
Outcome results
None listed