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

November 30, 2015 updated by: University Hospital, Basel, Switzerland

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Mirjam Christ-Crain
    • Aargau
      • Aarau, Aargau, Switzerland
        • Beat Müller

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

hospitalized patients with severe hypo or hypernatremia

Description

Inclusion Criteria:

  • hyponatremia <125 or hypernatremia >155 mmol/L

Exclusion Criteria:

  • no informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
hospitalized patients
hospitalized patients with hyponatremia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
participants will be followed for up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Kantonsspital Aarau

Investigators

  • Principal Investigator: Mirjam Christ-Crain, MD, PhD, University Hospital, Basel, Switzerland
  • Principal Investigator: Beat Müller, MD, Kantonsspital Aarau, University Hospital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

September 30, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (Estimate)

October 20, 2011

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMED Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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