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CompletedNCT01456533COMEDUpdated Dec 2, 2015

Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients

An observational study in Hyponatremia and Hypernatremia, sponsored by University Hospital, Basel, Switzerland. Completed at 2 sites in Switzerland. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2015-12-02.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 110 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hyponatremia
  • Hypernatremia

Keywords

  • hyponatremia
  • hypernatremia
03

In context

Hyponatremia

156 studies on the registry are indexed under Hyponatremia; 17 are open to participants now.

This study's enrollment of 300 is above the median of 190 across 58 observational studies indexed under Hyponatremia.

Browse Hyponatremia studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 989 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

hospitalized patients with severe hypo or hypernatremia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • hyponatremia \<125 or hypernatremia >155 mmol/L

Exclusion criteria

Exclusion Criteria:

  • no informed consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)

Groups and cohorts

  • hospitalized patients

    hospitalized patients with hyponatremia

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: participants will be followed for up to 1 year

07

Study locations

2 sites
  • Mirjam Christ-Crain
    Basel, Basel 4031, Switzerland
  • Beat Müller
    Aarau, Canton of Aargau, Switzerland
08

References and documents

Publications

  • Sailer CO, Winzeler B, Nigro N, Bernasconi L, Mueller B, Christ-Crain M. Influence of Outdoor Temperature and Relative Humidity on Incidence and Etiology of Hyponatremia. J Clin Endocrinol Metab. 2019 Apr 1;104(4):1304-1312. doi: 10.1210/jc.2018-01507. PubMed 30462243 ↗
  • Nigro N, Winzeler B, Suter-Widmer I, Schuetz P, Arici B, Bally M, Refardt J, Betz M, Gashi G, Urwyler SA, Burget L, Blum CA, Bock A, Huber A, Muller B, Christ-Crain M. Copeptin levels and commonly used laboratory parameters in hospitalised patients with severe hypernatraemia - the "Co-MED study". Crit Care. 2018 Feb 9;22(1):33. doi: 10.1186/s13054-018-1955-7. PubMed 29422070 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01456533
Collaborators
Kantonsspital Aarau
Responsible party
Sponsor
First posted
Oct 20, 2011
Start date
Oct 2011
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Dec 2, 2015

Study contacts

Mirjam Christ-Crain, MD, PhD
principal investigator · University Hospital, Basel, Switzerland
Beat Müller, MD
principal investigator · Kantonsspital Aarau, University Hospital Basel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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