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

Phase 1

• Conditions: Polyuria-polydipsia syndrome (PPS) is divided into the three main entities central (complete or partial) diabetes insipidus (DI), nephrogenic DI and primary polydipsia (PP).; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2018-004159-19-DE
• Lead Sponsor: niversity Hospital Basel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-03
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 152

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

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 clinical trial of medicinal product
• Study Design: Not specified