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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01940614
Other study ID # CODDI2013
Secondary ID
Status Completed
Phase
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
Health authority
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

Study Design


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
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