Relationship Between Heat Wave and Hyponatremia | NCT02012660

Studies
Relationship Between Heat Wave and Hyponatremia

NCT02012660

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Apr 29, 2015Estimated

Enrollment

28,734Actual

Phase

Not provided

Conditions

Hyponatremia

Interventions

Seasonality

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Dec 5, 2013

First Submission Date that Met QC Criteria

Dec 10, 2013

First Posted Date

Dec 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2015

Last Update Posted Date

Apr 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

We will explore the relationship between heat wave and moderate and severe hyponatremia in a population of adult patients admitted in the emergency department of a primary and tertiary care teaching urban hospital. We will compare the prevalence of hyponatremia between summer and winter periods. We will describe the types of observed hyponatremia and describe the characteristics of the patients suffering of moderate to severe hyponatremia.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28,734Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyponatremia, seasonality		Summer months = June, July, August Winter months = December, January, February	Other: Seasonality

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Seasonality	Other	The impact of high temperature during summer months on the prevalence of hyponatremia will be explores.	Hyponatremia, seasonality

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Mortality		December 2011 to August 2013
Hospital length of stay		December 2011 to August 2013

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all adults (> 16 y) with blood natremia measured

Exclusion Criteria:

Patients without measure of natremia in the emergency department

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier T Rutschmann, MD, MPH	University Hospital, Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Geneva University		Geneva	Canton of Geneva	1200	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D007010	Hyponatremia

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided