NCT01326429

Brief Summary

Hypo- and hypernatremia are the most frequent electrolyte disorders found in hospitalized patients. The increasing use of diuretics and other medications influencing the water and sodium homeostasis potentially lead to a rise in the prevalence of the electrolyte disorders. Only little data is available on the frequency and the mechanisms leading to hypo-/hypernatremia. Thus, the investigators aim to A.) determine the frequency of hypo- and hypernatremia in the emergency department of a large tertiary university hospital and B.) explore the mechanisms leading to the development of dysnatremias by detailed clinical and laboratory examinations.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2011

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

1.4 years

First QC Date

March 29, 2011

Last Update Submit

July 22, 2015

Conditions

Keywords

SodiumHyponatremiaHypernatremiaEmergency department

Outcome Measures

Primary Outcomes (1)

  • Frequency of hypo- and hypernatremia in the emergency department

    The investigators aim to determine the frequency of hypo- and hypernatremia in the emergency department of a large tertiary university hospital.

    approx. 6 months

Secondary Outcomes (1)

  • Origin of hypo- and hypernatremia in the emergency department

    approx. 6 months

Study Arms (2)

Hypernatremia

Patients admitted to the emergency department with a serum sodium exceeding 145 mmol/L.

Hyponatremia

Patients admitted to the emergency room with a serum sodium below 135 mmol/L.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to the emergency department of a large tertiary university hospital with a serum sodium below 135 mmol/L (hyponatremia) or exceeding 145 mmol/L.

You may qualify if:

  • Serum sodium below 135 mmol/L (i.e. hyponatremia); serum sodium exceeding 145 mmol/L (hypernatremia)

You may not qualify if:

  • Patients below age 18 years; patients declining study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

HyponatremiaHypernatremiaEmergencies

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gregor Lindner, M.D.

    Dept. of Nephrology and Hypertension, Inselspital Bern, University of Bern

    PRINCIPAL INVESTIGATOR
  • Felix J Frey, M.D.

    Dept. of Nephrology and Hypertension, Inselspital Bern, University of Bern

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2011

First Posted

March 30, 2011

Study Start

October 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

July 23, 2015

Record last verified: 2015-07