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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT06498856
Eligibility Criteria:
Inclusion Criteria:
* Plasma sodium 120-130 mmol/L
* Effective osmolality (2 x plasma sodium + plasma glucose) \< 275 milliosmol/L
* Age \> 18 years
Exclusion Criteria:
* Intensive care unit (ICU) admission
* Adequate sodium correction rate: \> 4 mmol/L last 24 hours
* Primary polydipsia: urine osmolality \< 100 mOsm/L
* Hypertonic saline therapy
* Adrenal insufficiency
* Severe heart failure: ejection fraction \< 35 % or clinical suspicion of decompensated heart failure
* Ascites grade 3 (marked abdominal distention and discomfort)
* Chronic renal failure stage 4 or 5: estimated glomerular filtration rate \< 30
* Failure to submit informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06498856
Study Brief:
Protocol Section:
NCT06498856