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Clinical Trials/NCT01456533
NCT01456533CompletedNot Applicable

Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients

University Hospital, Basel, Switzerland2 sites in 1 country300 target enrollmentStarted: October 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
300
Locations
2
Primary Endpoint
diagnostic accuracy of copeptin within hospital stay

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 110 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • hyponatremia <125 or hypernatremia >155 mmol/L

Exclusion Criteria

  • no informed consent

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Basel, Switzerland
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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