Clinical Trial: Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:
Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome: 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.


Original Primary Outcome: diagnostic accuracy of copeptin within hospital stay [ Time Frame: participants will be followed for the duration of hospital stay (for on average 14 days) ]

diagnostic accuracy will be determined by ROC analysis. The study is powered to detect a difference of copeptin levels between patients with partial central DI and patients with primary polydipsia.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: September 30, 2011
Date Started: October 2011
Date Completion:
Last Updated: November 30, 2015
Last Verified: November 2015