Copeptin in Normal- to Hyperosmolar States

Copeptin Blood Values Clinical Trial

Official title:

Kinetics of Copeptin in Healthy Volunteers - a Prospective International Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647736
• Other study ID #: CoNorm
• Status: Completed
• Phase: N/A
• First received: December 23, 2015
• Last updated: August 2, 2016
• Start date: September 2012

Study information

• Verified date: August 2016
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Kinetics of Copeptin in response to osmotic alterations in healthy volunteers

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Copeptin Blood Values

Intervention

Other:
• Hypertonic saline infusion

Locations

Country	Name	City	State
Germany	University Hospital Würzburg	Würzburg
Switzerland	University hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological relationship between Serum osmolality and Plasma copeptin release.	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	No
Primary	Half life of Copeptin	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	No