Clinical trial NCT01940614: Use of Copeptin in Diabetes Insipidus
Official title: Use of Copeptin in the Differential Diagnosis of Diabetes insipidus-a Prospective International Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Insipidus
Primary Polydipsia
Keywords: Copeptin
differential diagnosis of polyuria polydipsia syndrome
diabetes insipidus
compulsive water drinking
water deprivation test
Diabetes insipidus (central and nephrogenic)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-09-12
Enrollment: 156
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care center

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).

Eligibility criteria: 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

Primary outcomes:
measure: Overall diagnostic accuracy
timeFrame: beginning and end of protocol, up to 9hours
Secondary outcomes:
measure: Sensitivity, specificity, positive and negative predictive value
timeFrame: beginning and end of protocol, up to 9hours
measure: post-hoc best copeptin cut-off optimising overall performance
timeFrame: beginning and end of protocol, up to 9hours
measure: subjective burden as rated by patients on visual analogue scale
timeFrame: beginning, during and end of protocol, up to 9hours
measure: Predictive value of specific anamnestic and clinical features
timeFrame: before tests
measure: Predictive value of absent bright spot in posterior pituitary enlargement
timeFrame: before or after tests
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Univerisity Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital
name: Mirjam Christ-Crain
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sailer CO, Refardt J, Blum CA, Schnyder I, Molina-Tijeras JA, Fenske W, Christ-Crain M. Validity of different copeptin assays in the differential diagnosis of the polyuria-polydipsia syndrome. Sci Rep. 2021 May 12;11(1):10104. doi: 10.1038/s41598-021-89505-9.
citation: Fenske W, Refardt J, Chifu I, Schnyder I, Winzeler B, Drummond J, Ribeiro-Oliveira A Jr, Drescher T, Bilz S, Vogt DR, Malzahn U, Kroiss M, Christ E, Henzen C, Fischli S, Tonjes A, Mueller B, Schopohl J, Flitsch J, Brabant G, Fassnacht M, Christ-Crain M. A Copeptin-Based Approach in the Diagnosis of Diabetes Insipidus. N Engl J Med. 2018 Aug 2;379(5):428-439. doi: 10.1056/NEJMoa1803760.