Use of Copeptin in Diabetes Insipidus

Completed

• Conditions: Primary Polydipsia; Diabetes Insipidus

• Registration Number: NCT01940614
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of diabetes insipidus against the standard diagnostic test methods.

Detailed Description

Purpose of this study is to compare the overall diagnostic accuracy of the three following diagnostic test procedures in diabetes insipidus (central, nephrogenic) and primary polydipsia: a) classical water deprivation test alone, b) classical water deprivation test plus plasma copeptin cut-off levels, c) hypertonic saline infusion test plus plasma copeptin measurement.

The investigators hypothesize that firstly b) and c) is better as a). Secondly the investigators hypothesize that c) is non-inferior to b).

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-12
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Polyuria or/and Polydipsia or/and therapy with synthetic adenovirus proteinase (AVP) derivate
• Urine osmolality <800mOsm/kgH20

Exclusion Criteria

• Polyuria due to diabetes mellitus
• Hypokalemia
• Hyperkalemia (>5mmol/l)
• Hypercalcemia
• Kidney disease (min.: glomerular filtration rate (GFR) 60ml/min/1.73m2)
• Pregnancy
• Hyponatremia >135mmol/L
• Hypernatremia >145mmol/L
• Hypo- or hypervolemia
• uncorrected adrenal or thyroidal deficiency
• Cardia failure
• Epilepsia
• Uncontrolled hypertension

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall diagnostic accuracy	beginning and end of protocol, up to 9hours	Ratio of the number of correctly diagnosed patients to the number of all tested patients for the tests: * classical water deprivation test alone; * classical water deprivation test plus plasma copeptin cut-off levels; * hypertonic saline Infusion test plus plasma copeptin measurements

Secondary Outcome Measures

Name	Time	Method
Sensitivity, specificity, positive and negative predictive value	beginning and end of protocol, up to 9hours	each diagnostic test
post-hoc best copeptin cut-off optimising overall performance	beginning and end of protocol, up to 9hours	best copeptin cut-offs for differentiation between different diagnosis of polyuria-polydipsia syndrome
subjective burden as rated by patients on visual analogue scale	beginning, during and end of protocol, up to 9hours	water deprivation test and hypertonic saline Infusion test
Predictive value of specific anamnestic and clinical features	before tests	Evaluation of anamnestic and clinical features to test-independently predict final diagnosis of polyuria-polydipsia syndrome
Predictive value of absent bright spot in posterior pituitary enlargement	before or after tests	Evaluation of predictive value of absent bright spot in T1 weighted cranial MRI scans

Trial Locations

Locations (1)

Univerisity Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland