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Copeptin in Normal- to Hyperosmolar States

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ClinicalTrials.gov Identifier: NCT02647736
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Mirjam Christ-Crain, University Hospital, Basel, Switzerland

Brief Summary:
Kinetics of Copeptin in response to osmotic alterations in healthy volunteers

Condition or disease Intervention/treatment Phase
Copeptin Blood Values Other: Hypertonic saline infusion Not Applicable

Detailed Description:
Construction of the standard area of copeptin release in the normo- and hyperosmolar state and its half-life based on ist decline during hypoosmotic Suppression in healthy volunteers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Kinetics of Copeptin in Healthy Volunteers - a Prospective International Study
Study Start Date : September 2012
Actual Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Copeptin values in normo- to hyperosmolar states Other: Hypertonic saline infusion



Primary Outcome Measures :
  1. Physiological relationship between Serum osmolality and Plasma copeptin release. [ Time Frame: beginning and end of protocol, up to 8 hours ]

    Copeptin and Blood osmolality will be measured concomitantly while hypertonic saline is infused. The infusion is continued until a hyperosmolar state is reached (defined with a sodium-level of 150mmol/l).

    Definition of an area of normality describing the physiological relationship between Serum osmolality and Plasma copeptin release in normo- to hyperosmolar states.


  2. Half life of Copeptin [ Time Frame: beginning and end of protocol, up to 8 hours ]
    Calculation of Copeptin half-life based on its decline during hypoosmotic suppression (oral waterload and glucose 5%-infusion)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Minimum Age 18
  • no severe comorbidities
  • no medication (except contraceptives)
  • baseline sodium Level 135-145mmol/l
  • euvolemic status

Exclusion Criteria:

  • history of heart failure
  • liver cirrhosis
  • kidney disease (GFR <60ml/min)
  • anemia
  • uncontrolled Hypertension
  • pregnancy
  • Diabetes mellitus
  • BMI >28kg/m2
  • other severe disease

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): NCT02647736


Locations
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Germany
University Hospital Würzburg
Würzburg, Germany
Switzerland
University hospital Basel
Basel, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Mirjam Christ-Crain, Prof. University Hospital, Basel, Switzerland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mirjam Christ-Crain, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02647736    
Other Study ID Numbers: CoNorm
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Diabetes Insipidus
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases