Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients (COMED)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kantonsspital Aarau
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01456533
First received: September 30, 2011
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition
Hyponatremia
Hypernatremia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • diagnostic accuracy of copeptin within hospital stay [ Time Frame: participants will be followed for up to 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
hospitalized patients
hospitalized patients with hyponatremia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

hospitalized patients with severe hypo or hypernatremia

Criteria

Inclusion Criteria:

  • hyponatremia <125 or hypernatremia >155 mmol/L

Exclusion Criteria:

  • no informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456533

Locations
Switzerland
Beat Müller
Aarau, Aargau, Switzerland
Mirjam Christ-Crain
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Kantonsspital Aarau
Investigators
Principal Investigator: Mirjam Christ-Crain, MD, PhD University Hospital, Basel, Switzerland
Principal Investigator: Beat Müller, MD Kantonsspital Aarau, University Hospital Basel
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01456533     History of Changes
Other Study ID Numbers: COMED Study
Study First Received: September 30, 2011
Last Updated: June 11, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
hyponatremia
hypernatremia

Additional relevant MeSH terms:
Hypernatremia
Hyponatremia
Metabolic Diseases
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on November 25, 2014