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NCT01456533 Clinical Trial

Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients

Hyponatremia Clinical Trial

— COMED  

Official title:
Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01456533
Other study ID # COMED Study
Secondary ID
Status Completed
Phase N/A
First received September 30, 2011
Last updated November 30, 2015
Start date October 2011
Est. completion date April 2015

Study information
Verified date November 2015
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 110 Years
Eligibility Inclusion Criteria:

- hyponatremia <125 or hypernatremia >155 mmol/L

Exclusion Criteria:

- no informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Beat Müller Aarau Aargau
Switzerland Mirjam Christ-Crain Basel

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland Kantonsspital Aarau

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary diagnostic accuracy of copeptin within hospital stay 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 No
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