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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT03202667
Eligibility Criteria:
Inclusion Criteria:
Adult patients (age ≥ 18 years) with hyponatremia (\<133mmol/l) due to chronic (\>72h) SIADH defined as
* serum osmolality \<275mosm/kg
* urine osmolality \>100mosm/kg
* urine sodium \>30mmol/l
Exclusion Criteria:
* acute (\<72h) or transient hyponatremia
* severe symptomatic hyponatremia in need of hospital treatment
* diabetes mellitus type 1
* uncontrolled hypothyroidism
* uncontrolled adrenal insufficiency
* renal impairment (GFR \<45ml/min)
* cardiac failure
* symptomatic liver disease / severe hepatic impairment (ALAT / aspartate transaminase (ASAT) \> 3x upper limit)
* treatment with SGLT 2 inhibitors, lithium chloride, urea or glitazone
* severe immunosuppression
* pregnancy or breastfeeding
* palliative situation (end of life care)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03202667
Study Brief:
Protocol Section:
NCT03202667