Copeptin in Normal- to Hyperosmolar States

NCT02647736 — Not applicable, Completed, 90 participants, University Hospital, Basel, Switzerland

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Kinetics of Copeptin in Healthy Volunteers - a Prospective International Study

Registry	NCT02647736
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none
Enrollment	90 (Actual)
Sponsor	University Hospital, Basel, Switzerland (Other)
Conditions	Copeptin Blood Values
Interventions	Hypertonic saline infusion (Other)
Dates	start 2012-09-01, primary completion 2016-07-01, first posted 2016-01-06, last updated 2016-08-03
Locations	2 sites in Germany, Switzerland

-Summary

Kinetics of Copeptin in response to osmotic alterations in healthy volunteers

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Copeptin values in normo- to hyperosmolar states	Experimental	Other: Hypertonic saline infusion

Hypertonic saline infusion (Other)

+Outcome measures

Primary outcomes

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.
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)

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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

+Locations (2)

Facility	City	Country	Status
University Hospital Würzburg	Würzburg	Germany
University hospital Basel	Basel	Switzerland

+Publications

Results publication: Sailer CO, Refardt J, Blum CA, Schnyder I, Molina-Tijeras JA, Fenske W, Christ-Crain M. Validity of different copeptin assays in the differential diagnosis of the polyuria-polydipsia syndrome. Sci Rep. 2021 May 12;11(1):10104. doi: 10.1038/s41598-021-89505-9. PMID 33980941
Results publication: Fenske WK, Schnyder I, Koch G, Walti C, Pfister M, Kopp P, Fassnacht M, Strauss K, Christ-Crain M. Release and Decay Kinetics of Copeptin vs AVP in Response to Osmotic Alterations in Healthy Volunteers. J Clin Endocrinol Metab. 2018 Feb 1;103(2):505-513. doi: 10.1210/jc.2017-01891. PMID 29267966

+Investigators

Mirjam Christ-Crain, Prof., Principal investigator, University Hospital, Basel, Switzerland

My Notes

Public

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