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 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT03572166
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Hypotonic polyuria / polydipsia syndrome defined as: polyuria \>50ml/kg body weight/24h and polydipsia \>3l /24h or known diabetes insipidus under treatment with DDAVP
* Urine-Osmolality \<800mOsm/L
Exclusion Criteria:
* Polyuria / polydipsia secondary to diabetes mellitus, hypercalcemia or hypokalemia
* Nephrogenic diabetes insipidus (defined as baseline copeptin level \>21.4pmol/L)
* Evidence of any acute illness
* Epilepsy requiring treatment
* Uncontrolled arterial hypertension (blood pressure \>160/100mmHg at baseline)
* Cardiac failure (NYHA III-IV)
* Liver cirrhosis (Child B-C)
* Uncorrected adrenal or thyroidal deficiency
* Patients refusing or unable to give written informed consent
* Pregnancy or breast feeding
* End of life care
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT03572166
Study Brief:
Protocol Section:
NCT03572166