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Use of Copeptin in Diabetes Insipidus

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ClinicalTrials.gov Identifier: NCT01940614
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date September 9, 2013
First Posted Date September 12, 2013
Last Update Posted Date April 17, 2018
Actual Study Start Date July 2013
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2018)
Overall diagnostic accuracy [ Time Frame: 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
Original Primary Outcome Measures
 (submitted: September 11, 2013)
Discriminative value of copeptin during different diagnostic tests. [ Time Frame: beginning and end of protocol, up to 8hours ]
Change History
Current Secondary Outcome Measures
 (submitted: April 12, 2018)
  • Sensitivity, specificity, positive and negative predictive value [ Time Frame: beginning and end of protocol, up to 9hours ]
    each diagnostic test
  • post-hoc best copeptin cut-off optimising overall performance [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: before or after tests ]
    Evaluation of predictive value of absent bright spot in T1 weighted cranial MRI scans
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Use of Copeptin in Diabetes Insipidus
Official Title Use of Copeptin in the Differential Diagnosis of Diabetes insipidus-a Prospective International Study
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary care center
Condition
  • Diabetes Insipidus
  • Primary Polydipsia
Intervention
  • Other: Water deprivation test
    Classical water deprivation test alone
  • Other: Water deprivation test
    classical water deprivation test plus plasma copeptin cut-off levels
  • Other: Hypertonic saline infusion
    hypertonic saline infusion test plus plasma copeptin measurement
Study Groups/Cohorts Not Provided
Publications * 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, Tönjes 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 12, 2018)
156
Original Estimated Enrollment
 (submitted: September 11, 2013)
140
Actual Study Completion Date December 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01940614
Other Study ID Numbers CODDI2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor University Hospital, Basel, Switzerland
Collaborators Not Provided
Investigators
Principal Investigator: Mirjam Christ-Crain University Hospital
PRS Account University Hospital, Basel, Switzerland
Verification Date April 2018