NCT03572166

Use of Copeptin Measurement After Arginine Infusion for the Differential Diagnosis of Diabetes Insipidus - the CARGOx Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The differential diagnosis of central diabetes insipidus (cDI) is difficult and the current test with the highest diagnostic accuracy is copeptin measurement after hypertonic saline infusion (HIS). Although the HIS improved diagnostic accuracy compared to the standard water deprivation test used for decades before, it still comprises great discomfort for patients due to the rise in serum sodium levels above 149mmol/l and requires the presence of medical staff at all times to guarantee safety of the test. The arginine stimulation test is routinely used to stimulate growth hormone. Own data in 52 patients with polyuria / polydipsia syndrome showed that arginine infusion is a potent stimulator of the neurohypophysis and provides a new diagnostic tool in the differential diagnosis of cDI. Copeptin measurements upon arginine stimulation (CAS) discriminated patients with diabetes insipidus vs. patients with primary polydipsia with a high diagnostic accuracy of 94%. To validate these results and to compare them against the HIS a large multicenter trial is needed, where the diagnostic accuracy of the CAS is compared to the HIS.

Conditions

• Diabetes Insipidus
• Polydipsia, Primary

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Arginine infusion	Intravenous Infusion of Arginine is given, copeptin measurement will be collected before and 60minutes after start of infusion
DIAGNOSTIC_TEST	Hypertonic saline infusion	Intravenous Infusion of hypertonic Saline is given, copeptin measurement will be collected before and once Plasma sodium rises above 149mmol/l

Timeline

• Start date: 2018-09-03
• Primary completion: 2022-09-30
• Completion: 2022-12-31
• First posted: 2018-06-28
• Last updated: 2023-07-27

Locations

7 sites across 6 countries: Brazil, Germany, Italy, Netherlands, Switzerland, United Kingdom