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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

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

Condition or disease Intervention/treatment
Diabetes Insipidus Primary Polydipsia Other: Water deprivation test Other: Hypertonic saline infusion

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
Actual Enrollment : 156 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Copeptin in the Differential Diagnosis of Diabetes insipidus-a Prospective International Study
Actual Study Start Date : July 2013
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017



Intervention Details:
    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


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Sensitivity, specificity, positive and negative predictive value [ Time Frame: beginning and end of protocol, up to 9hours ]
    each diagnostic test

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care center
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940614


Locations
Switzerland
Univerisity Hospital Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Mirjam Christ-Crain University Hospital

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01940614     History of Changes
Other Study ID Numbers: CODDI2013
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by University Hospital, Basel, Switzerland:
Copeptin
differential diagnosis of polyuria polydipsia syndrome
diabetes insipidus
compulsive water drinking
water deprivation test
Diabetes insipidus (central and nephrogenic)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Insipidus
Polydipsia
Polydipsia, Psychogenic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Pathologic Processes
Signs and Symptoms
Behavioral Symptoms
Neurobehavioral Manifestations
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs