Copeptin in Normal- to Hyperosmolar States

Not Applicable

Completed

• Conditions: Copeptin Blood Values
• Interventions: Other: Hypertonic saline infusion

• Registration Number: NCT02647736
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Kinetics of Copeptin in response to osmotic alterations in healthy volunteers

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-06
• Primary Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-02
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Copeptin values in normo- to hyperosmolar states	Hypertonic saline infusion	-

Primary Outcome Measures

Name	Time	Method
Half life of Copeptin	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)
Physiological relationship between Serum osmolality and Plasma copeptin release.	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.

Trial Locations

Locations (2)

University Hospital Würzburg; 🇩🇪 Würzburg, Germany

University hospital Basel; 🇨🇭 Basel, Switzerland