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:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT01890694
Eligibility Criteria:
Inclusion Criteria:
* Cirrhosis
* Screening within 24 hours of admission
* Na level less than 130mEq/L
* Presence of fluid overload with either history of ascites or edema
* Cr \< 2.0mg/dl
* Planned length of stay after randomization of at least 24 hours
* Anticipated survival of at least 8 days
* Ability to provide informed consent
Exclusion Criteria:
* Hospitalization greater than 24 hours at screening
* Depletional hyponatremia
* Hyponatremia due to hyperglycemia
* Acute and transient hyponatremia associated with head trauma or post-operative states
* Hyponatremia due to primary polydipsia, adrenal insufficiency, or hypothyroidism
* Urgent need for treatment of hyponatremia with saline or hypertonic saline
* Treatment with demeclocycline, lithium chloride, and urea
* Cr greater than 2.0mg/dl
* Stage 3 or 4 hepatic encephalopathy
* Inability to provide informed consent
* Planned discharge within 24 hours
* Anticipated survival less than 8 days
* GI bleeding within one month of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01890694
Study Brief:
Protocol Section:
NCT01890694