se of Copeptin Measurement after Arginine Infusion for the Diagnosis of Diabetes Insipidus - the CARGOx Study

Completed

Conditions: diabetes insipidus
polyuria-polydipsia syndrome
10021112

Registration Number: NL-OMON48431

Lead Sponsor: Prof. Mirjam Christ-Crain, University Hospital Basel (USB)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Age >= 18 years
2. 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

1. Polyuria / polydipsia secondary to diabetes mellitus, hypercalcemia or
hypokalemia
2. Nephrogenic diabetes insipidus (defined as baseline copeptin level
>21.4pmol/L)
3. Evidence of any acute illness
4. Epilepsy requiring treatment
5. Uncontrolled arterial hypertension (blood pressure >160/100mmHg at baseline)
6. Cardiac failure (NYHA III-IV)
7. Liver cirrhosis (Child B-C)
8. Uncorrected adrenal or thyroidal deficiency
9. Patients refusing or unable to give written informed consent
10. Pregnancy or breast feeding
11. End of life care

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the overall diagnostic accuracy - defined as the<br /><br>proportion of correct diagnoses - of each diagnostic procedure in<br /><br>differentiating patients with central diabetes insipidus (cDI) from patients<br /><br>with primary polydipsia (PP).<br /><br>Copeptin measurement after arginine-stimulation (CAS) will be compared for<br /><br>non-inferiority to the current best diagnostic test copeptin measurement after<br /><br>hypertonic saline infusion (HIS).</p><br>

Secondary Outcome Measures