ED Hypernatremia. Prognostic Factors and Epidemiology. | NCT04265976

Studies
ED Hypernatremia. Prognostic Factors and Epidemiology.

NCT04265976

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Unknown status

Last Update Posted

Feb 17, 2020Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Hypernatremia

Interventions

Not provided

Countries

France

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

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 26, 2019Actual

Primary Completion Date

May 26, 2020Estimated

Completion Date

Sep 1, 2020Estimated

First Submitted Date

Feb 10, 2020

First Submission Date that Met QC Criteria

Feb 10, 2020

First Posted Date

Feb 12, 2020Actual

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

Feb 13, 2020

Last Update Posted Date

Feb 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study evaluate the 1-month mortality of patients who proceed a blood sample while in the ED with an hypernatremia (>145 mmol/l). This prospective study will try to show several prognostic factors, and show the epidemiology of hypernatremia in this single center evaluation.

Detailed Description

Not provided

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

250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
one month survival	Survival at 1 month after the blood sample at the ED	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Natremia > 145 mmol/l

Exclusion Criteria:

Age < 18 years
Refusal

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Every >18 years old patient from who a blood sample was taken in the ED with a natremia > 145 mmol/l and don't show a refusal after information.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Romain ADAM, Resident	Contact	+33646470168		radam@chu-besancon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Besançon	Recruiting	Besançon		25000	France

Condition Browse Module

MeSH Terms

ID	Term
D006955	Hypernatremia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided