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Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients (COMED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01456533
First Posted: October 20, 2011
Last Update Posted: December 2, 2015
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:
Kantonsspital Aarau
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
  Purpose

Background: Hypo- and hypernatremia are common in hospitalized patients. The differential diagnosis of dysnatremia is challenging.

Osmotically inadequate secretion of antidiuretic hormone (ADH) is the predominant mechanism in most dysnatremic disorders. ADH measurement is cumbersome. It is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of ADH.

Objective: To evaluate the additional value of copeptin to improve a currently used algorithm in the differential diagnosis of (A) severe hypoosmolar hypo- and (B) severe hypernatremia.

Design: Prospective observational study.


Condition
Hyponatremia Hypernatremia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • diagnostic accuracy of copeptin within hospital stay [ Time Frame: participants will be followed for up to 1 year ]
    diagnostic accuracy will be determined by receiver operated curve (ROC) analysis. The study is powered to detect a difference of copeptin levels between patients with partial central diabetes insipidus (DI) and patients with primary polydipsia.


Enrollment: 300
Study Start Date: October 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
hospitalized patients
hospitalized patients with hyponatremia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
hospitalized patients with severe hypo or hypernatremia
Criteria

Inclusion Criteria:

  • hyponatremia <125 or hypernatremia >155 mmol/L

Exclusion Criteria:

  • no informed consent
  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): NCT01456533


Locations
Switzerland
Beat Müller
Aarau, Aargau, Switzerland
Mirjam Christ-Crain
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Kantonsspital Aarau
Investigators
Principal Investigator: Mirjam Christ-Crain, MD, PhD University Hospital, Basel, Switzerland
Principal Investigator: Beat Müller, MD Kantonsspital Aarau, University Hospital Basel
  More Information

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01456533     History of Changes
Other Study ID Numbers: COMED Study
First Submitted: September 30, 2011
First Posted: October 20, 2011
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by University Hospital, Basel, Switzerland:
hyponatremia
hypernatremia

Additional relevant MeSH terms:
Hyponatremia
Hypernatremia
Water-Electrolyte Imbalance
Metabolic Diseases