Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients

NCT01456533 | Completed

• 1 other identifier: COMED Study
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Hyponatremia; Hypernatremia

Keywords

hyponatremia; hypernatremia

Outcome Measures

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.

  participants will be followed for up to 1 year

Study Arms (1)

hospitalized patients

hospitalized patients with hyponatremia

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

hospitalized patients with severe hypo or hypernatremia

You may qualify if:

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

You may not qualify if:

• no informed consent

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Kantonsspital Aarau: collaborator

Study Sites (2)

Mirjam Christ-Crain

Basel, Basel, 4031, Switzerland

Location

Beat Müller

Aarau, Canton of Aargau, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 30462243 DERIVED

• 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.

  PMID: 29422070 DERIVED

MeSH Terms

Conditions

Hyponatremia; Hypernatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mirjam Christ-Crain, MD, PhD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Beat Müller, MD

  Kantonsspital Aarau, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 20, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

CH (2)