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

This study is ongoing, but not recruiting participants.
Kantonsspital Aarau
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland Identifier:
First received: September 30, 2011
Last updated: March 9, 2015
Last verified: March 2015

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.


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

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 ] [ Designated as safety issue: No ]
    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.

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
hospitalized patients with severe hypo or hypernatremia

Inclusion Criteria:

  • hyponatremia <125 or hypernatremia >155 mmol/L

Exclusion Criteria:

  • no informed consent
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Please refer to this study by its identifier: NCT01456533

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

No publications provided

Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT01456533     History of Changes
Other Study ID Numbers: COMED Study
Study First Received: September 30, 2011
Last Updated: March 9, 2015
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:

Additional relevant MeSH terms:
Metabolic Diseases
Water-Electrolyte Imbalance processed this record on November 25, 2015