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Assessment of Circulating Copeptin Levels in Healthy Subjects and Patients With Renal Insufficiency After Oral Water Load and Hypertonic Saline Infusion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00696605
First Posted: June 12, 2008
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Brahms AG
Information provided by (Responsible Party):
Jonas Rutishauser, Hospital Centre Biel/Bienne
  Purpose

The are 2 principal goals in this study:

  1. To measure plasma copeptin levels in healthy subjects and to correlate them with plasma AVP concentrations and urine osmolalities in iso-, hypo-, and hyperosmolar states.
  2. To measure plasma copeptin concentrations in patients with chronic renal failure under the same conditions described above, in order to characterize the impact of renal function on circulating copeptin levels in correlation to plasma AVP and urine osmolality.

Condition
Hypoosmolality Hyperosmolality Renal Failure

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Assessment of Circulating Copeptin Levels in Healthy Subjects and Patients With Renal Insufficiency After Oral Water Load and Hypertonic Saline Infusion

Resource links provided by NLM:


Further study details as provided by Jonas Rutishauser, Hospital Centre Biel/Bienne:

Enrollment: 20
Study Start Date: July 2008
Study Completion Date: October 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers; patients with chronic renal failure
Criteria

Inclusion Criteria:

  • chronic renal failure grade I through IV
  • healthy age-matched controls

Exclusion Criteria:

  • chronic renal failure grade V
  • heart failure
  • liver disease
  • nephrotic syndrome
  • anemia (hemoglobin level < 100 g/L)
  • uncontrolled hypertension (systolic BP > 160 mmHg; diastolic BP > 95 mm Hg)
  • coexisting severe disease
  • known thyroid disease
  • known hypocortisolism
  • known hypercortisolism
  • known diabetes insipidus
  • pregnancy
  • lactation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696605


Locations
Switzerland
Clinic of Internal Medicine, Hospital Center
Biel/Bienne, Switzerland, 2501
Sponsors and Collaborators
Hospital Centre Biel/Bienne
Brahms AG
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonas Rutishauser, M.D., Hospital Centre Biel/Bienne
ClinicalTrials.gov Identifier: NCT00696605     History of Changes
Other Study ID Numbers: Swiss AVP-Copeptin Trial
First Submitted: June 10, 2008
First Posted: June 12, 2008
Last Update Posted: February 27, 2017
Last Verified: February 2017

Keywords provided by Jonas Rutishauser, Hospital Centre Biel/Bienne:
Hypoosmolality
Hyperosmolality
Copeptin
Vasopressin

Additional relevant MeSH terms:
Renal Insufficiency
Diabetes Insipidus
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs