Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients
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