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Trial record 2 of 24 for:    Recruiting, Not yet recruiting, Available Studies | Diabetes insipidus

Use of Copeptin Measurement After Arginine Infusion for the Differential Diagnosis of Diabetes Insipidus - the CARGOx Study (CARGOx)

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ClinicalTrials.gov Identifier: NCT03572166
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
Kantonsspital Aarau
Luzerner Kantonsspital
Kantonsspital St. Gallen, Switzerland
University Hospital, Zürich
Wuerzburg University Hospital
University Hospital Lübeck
Federal University of Minas Gerais
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:

The differential diagnosis of central diabetes insipidus (cDI) is difficult and the current test with the highest diagnostic accuracy is copeptin measurement after hypertonic saline infusion (HIS). Although the HIS improved diagnostic accuracy compared to the standard water deprivation test used for decades before, it still comprises great discomfort for patients due to the rise in serum sodium levels above 149mmol/l and requires the presence of medical staff at all times to guarantee safety of the test.

The arginine stimulation test is routinely used to stimulate growth hormone. Own data in 52 patients with polyuria / polydipsia syndrome showed that arginine infusion is a potent stimulator of the neurohypophysis and provides a new diagnostic tool in the differential diagnosis of cDI. Copeptin measurements upon arginine stimulation (CAS) discriminated patients with diabetes insipidus vs. patients with primary polydipsia with a high diagnostic accuracy of 94%.

To validate these results and to compare them against the HIS a large multicenter trial is needed, where the diagnostic accuracy of the CAS is compared to the HIS.


Condition or disease Intervention/treatment Phase
Diabetes Insipidus Polydipsia, Primary Diagnostic Test: Arginine infusion Diagnostic Test: Hypertonic saline infusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Observational randomized cross-over diagnostic international multicenter study
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Use of Copeptin Measurement After Arginine Infusion for the Differential Diagnosis of Diabetes Insipidus - the CARGOx Study
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arginine Infusion
Arginine Stimulation Test
Diagnostic Test: Arginine infusion
Intravenous Infusion of Arginine is given, copeptin measurement will be collected before and 60minutes after start of infusion

Active Comparator: Hypertonic saline infusion
Hypertonic Saline Infusion Test
Diagnostic Test: Hypertonic saline infusion
Intravenous Infusion of hypertonic Saline is given, copeptin measurement will be collected before and once Plasma sodium rises above 149mmol/l




Primary Outcome Measures :
  1. The primary outcome is the overall diagnostic accuracy - defined as the proportion of correct diagnoses - of each diagnostic procedure in differentiating patients with central diabetes insipidus from patients with primary polydipsia. [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Sensitivity of both diagnostic procedures for each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) according to recommended diagnostic test criteria and previously generated cutoff values [ Time Frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial) ]
  2. Specificity of both diagnostic procedures for each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) according to recommended diagnostic test criteria and previously generated cutoff values [ Time Frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial) ]
  3. Positive predictive value of both diagnostic procedures for each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) according to recommended diagnostic test criteria and previously generated cutoff values [ Time Frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial) ]
  4. Negative predictive value of both diagnostic procedures for each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) according to recommended diagnostic test criteria and previously generated cutoff values [ Time Frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial) ]
  5. Best fit diagnostic copeptin cut-off values for differentiation between each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) upon arginine stimulation and hypertonic saline infusion stimulation [ Time Frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial) ]
  6. Accuracy of the copeptin cut-off of 3.5pmol/l for Arginine Stimulation test [ Time Frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial) ]
  7. Sensitivity of the copeptin cut-off of 3.5pmol/l for Arginine Stimulation test [ Time Frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial) ]
  8. Specificity of the copeptin cut-off of 3.5pmol/l for Arginine Stimulation test [ Time Frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial) ]
  9. Accuracy of the copeptin cut-off of 6.5pmol/l for Hypertonic Saline Infusion test [ Time Frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial) ]
  10. Sensitivity of the copeptin cut-off of 6.5pmol/l for Hypertonic Saline Infusion test [ Time Frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial) ]
  11. Specificity of the copeptin cut-off of 6.5pmol/l for Hypertonic Saline Infusion test [ Time Frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial) ]
  12. Frequency and severity of thirst assessed by visual analogue scale during both tests [ Time Frame: 2 days (1 for each test) ]
    assessed by visual analogue scale from 0 to 10, with 0 indicating no symptoms and 10 indicating severe symptoms.

  13. Frequency and severity of headache assessed by visual analogue scale during both tests [ Time Frame: 2 days (1 for each test) ]
    assessed by visual analogue scale from 0 to 10, with 0 indicating no symptoms and 10 indicating severe symptoms.

  14. Frequency and severity of nausea assessed by visual analogue scale during both tests [ Time Frame: 2 days (1 for each test) ]
    assessed by visual analogue scale from 0 to 10, with 0 indicating no symptoms and 10 indicating severe symptoms.

  15. Frequency and severity of vertigo assessed by visual analogue scale during both tests [ Time Frame: 2 days (1 for each test) ]
    assessed by visual analogue scale from 0 to 10, with 0 indicating no symptoms and 10 indicating severe symptoms.

  16. Frequency and severity of general malaise assessed by visual analogue scale during both tests [ Time Frame: 2 days (1 for each test) ]
    assessed by visual analogue scale from 0 to 10, with 0 indicating no symptoms and 10 indicating severe symptoms.

  17. Subjective burden assessed by visual analogue scale of both tests [ Time Frame: 2 days (1 for each test) ]
    assessed by visual analogue scale from 0 to 10, with 0 indicating no symptoms and 10 indicating severe symptoms.

  18. Health care costs of both tests [ Time Frame: 2 days (1 for each test) ]
  19. Frequency of test preference at follow up visit [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Hypotonic polyuria / polydipsia syndrome defined as: polyuria >50ml/kg body weight/24h and polydipsia >3l /24h or known diabetes insipidus under treatment with DDAVP
  • Urine-Osmolality <800mOsm/L

Exclusion Criteria:

  • Polyuria / polydipsia secondary to diabetes mellitus, hypercalcemia or hypokalemia
  • Nephrogenic diabetes insipidus (defined as baseline copeptin level >21.4pmol/L)
  • Evidence of any acute illness
  • Epilepsy requiring treatment
  • Uncontrolled arterial hypertension (blood pressure >160/100mmHg at baseline)
  • Cardiac failure (NYHA III-IV)
  • Liver cirrhosis (Child B-C)
  • Uncorrected adrenal or thyroidal deficiency
  • Patients refusing or unable to give written informed consent
  • Pregnancy or breast feeding
  • End of life care

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): NCT03572166


Contacts
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Contact: Mirjam Christ-Crain, Prof, MD +41 61 265 50 78 mirjam.christ@usb.ch
Contact: Julie Refardt, MD +41 61 328 76 08 julie.refardt@usb.ch

Locations
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Switzerland
University Hospital Basel, Department of Endocrinology Recruiting
Basel, Basel Stadt, Switzerland, 4031
Contact: Julie Refardt, Dr., MD    +41 61 328 76 08    julie.refardt@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Kantonsspital Aarau
Luzerner Kantonsspital
Kantonsspital St. Gallen, Switzerland
University Hospital, Zürich
Wuerzburg University Hospital
University Hospital Lübeck
Federal University of Minas Gerais
Investigators
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Principal Investigator: Mirjam Christ-Crain, Prof, MD University Hospital, Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03572166     History of Changes
Other Study ID Numbers: CARGOx
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
Copeptin

Additional relevant MeSH terms:
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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