Copeptin test after mannitol vs hypertonic saline to diagnose PPS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, cross-over, multicenter trial compares two copeptin-stimulated diagnostic tests for polyuria-polydipsia syndrome: mannitol infusion versus hypertonic saline infusion. Participants undergo both tests in random order to assess diagnostic accuracy, safety, tolerability, and patient preference. The study also explores whether additional clinical and laboratory measures can improve diagnostic precision. Eligible adults with hypotonic PPS and suspected AVP deficiency or primary polydipsia are included, while those with confounding medical conditions are excluded. Lead site is University Hospital Basel, with collaboration in Basel, Switzerland.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years
2. Hypotonic polyuria/polydipsia syndrome defined as polyuria \>40ml/kg body weight/24h and polydipsia \>3l/24h; and urine osmolality \<800mOsm/L or known AVP-D based on accepted criteria

Exclusion Criteria:

1. Polyuria/polydipsia secondary to diabetes mellitus, hypercalcemia, or hypokalemia
2. Diagnosis of AVP-R (Copeptin \> 21.4 pmol/L)
3. Evidence of acute illness
4. Epilepsy requiring treatment
5. Uncontrolled arterial hypertension (blood pressure \>160/100mmHg at baseline
6. eGFR \< 60 ml/min/1,73 m2
7. Cardiac failure (NYHA III-IV)
8. Diagnosis of liver cirrhosis, Child-Pugh Class C
9. Uncorrected adrenal or thyroidal deficiency
10. Pregnancy or breastfeeding
11. Current or unresolved urinary obstruction
12. Enrollment in a clinical trial within the last 30 days
13. Patients refusing or unable to give written informed consent
14. Inability to follow study procedures

Where it's running

• University Hospital Basel
  Basel, Switzerland Recruiting

Study contacts

• Study coordinator: Talitha Hildebrandt
• Email: talithanatalja.hildebrandt@usb.ch
• Phone: +41 61 55 65075

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.