Use of Copeptin in Diabetes Insipidus

Diabetes Insipidus Clinical Trial

Official title:

Use of Copeptin in the Differential Diagnosis of Diabetes insipidus-a Prospective International Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940614
• Other study ID #: CODDI2013
• Status: Completed
• First received: September 9, 2013
• Last updated: April 12, 2018
• Start date: July 2013
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Insipidus
• Diabetes Mellitus
• Polydipsia
• Primary Polydipsia

Intervention

Other:
• Water deprivation test
Classical water deprivation test alone
• Water deprivation test
classical water deprivation test plus plasma copeptin cut-off levels
• Hypertonic saline infusion
hypertonic saline infusion test plus plasma copeptin measurement

Locations

Country	Name	City	State
Switzerland	Univerisity Hospital Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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