Copeptin in Normal- to Hyperosmolar States

August 2, 2016 updated by: Mirjam Christ-Crain, University Hospital, Basel, Switzerland

Kinetics of Copeptin in Healthy Volunteers - a Prospective International Study

Kinetics of Copeptin in response to osmotic alterations in healthy volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Würzburg, Germany
        • University Hospital Würzburg
  • Switzerland
      • Basel, Switzerland
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
beginning and end of protocol, up to 8 hours
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)
beginning and end of protocol, up to 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Mirjam Christ-Crain, Prof., University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CoNorm

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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