NCT02012660

Brief Summary

The objective of this study is to explore the relationship between moderate to severe hyponatremia and heat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28,734

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

December 5, 2013

Last Update Submit

April 28, 2015

Conditions

Hyponatremia

Outcome Measures

Primary Outcomes (1)

  • Number of patients with moderate to severe hyponatremia

    Moderate to severe hyponatremia is defined as Sodium blood levels \< 125 mmol/L

    Natremia measured at admission in the ED

Secondary Outcomes (2)

  • Mortality

    December 2011 to August 2013

  • Hospital length of stay

    December 2011 to August 2013

Study Arms (1)

Hyponatremia, seasonality

Summer months = June, July, August Winter months = December, January, February

Other: Seasonality

Interventions

SeasonalityOTHER

The impact of high temperature during summer months on the prevalence of hyponatremia will be explores.

Also known as: Summer = June, July, August, Winter = December, January, February
Hyponatremia, seasonality

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults admitted to the emergency departement of a primary and tertiary care teaching hospital

You may qualify if:

  • all adults (\> 16 y) with blood natremia measured

You may not qualify if:

  • Patients without measure of natremia in the emergency department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University

Geneva, Canton of Geneva, 1200, Switzerland

Location

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Olivier T Rutschmann, MD, MPH

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 16, 2013

Study Start

February 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations

CH(1)