Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients

Completed

• Conditions: Hypernatremia; Hyponatremia

• Registration Number: NCT01456533
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-30
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-20
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• hyponatremia <125 or hypernatremia >155 mmol/L

Exclusion Criteria

• no informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy of copeptin within hospital stay	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.

Trial Locations

Locations (2)

Mirjam Christ-Crain; 🇨🇭 Basel, Switzerland

Beat Müller; 🇨🇭 Aarau, Aargau, Switzerland