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Completed

NCT Number: NCT02647736

Copeptin in Normal- to Hyperosmolar States

Kinetics of Copeptin in response to osmotic alterations in healthy volunteers

Completed

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Key information

Conditions

Copeptin Blood Values

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Würzburg, Würzburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypertonic Saline Infusion

Other

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Kinetics of Copeptin in Healthy Volunteers - a Prospective International Study

Important dates

Study start
2012
Primary completion
2016
First posted
Jan 6, 2016
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.