Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT01240668
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥18 years old who are hospitalized
* Euvolemic or hypervolemic hyponatremia with serum sodium ≤130mmol/L
* For euvolemic hyponatremia:
* Euvolemia is defined as: absence of clinical and historical evidence of extracellular fluid volume depletion or sequestration; and absence of edema and ascites; or
* Physician diagnosis of SIADH
* For hypervolemic hyponatremia (applies to USA sites only):
* Hypervolemia is defined as: excess extracellular fluid volume manifesting as dependent edema or ascites
* Patients may have one or more of the following underlying co-morbid conditions:
* Congestive heart failure
* Cirrhosis and/or liver failure
* Nephrotic syndrome
Exclusion Criteria:
* Patients with hypovolemic hyponatremia
* Use of investigational drug, biologic, or device during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01240668
Study Brief:
Protocol Section:
NCT01240668