CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 177 enrolled
Drug / intervention
Arginine infusion +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03572166
NCT03572166N/ACompleted

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

University Hospital, Basel, Switzerland·interventional·Posted Jun 28, 2018·Updated Jul 27, 2023

In Brief

A clinical study evaluating Arginine infusion and Hypertonic saline infusion for Diabetes Insipidus and Polydipsia, Primary. Completed, enrolled 177 participants across 7 sites in 6 countries.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 28, 2018
Enrollment StartSep 3, 2018
Primary CompletionSep 30, 2022
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 8.0 years ago

Interventions

Arginine infusionother

Intravenous Infusion of Arginine is given, copeptin measurement will be collected before and 60minutes after start of infusion

Hypertonic saline infusionother

Intravenous Infusion of hypertonic Saline is given, copeptin measurement will be collected before and once Plasma sodium rises above 149mmol/l