Hypophosphatemia as a Predictor in Surgical Resuscitation... | NCT03740802

Studies
Hypophosphatemia as a Predictor in Surgical Resuscitation Sepsis

NCT03740802

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Nov 27, 2018Actual

Enrollment

264Actual

Phase

Not provided

Conditions

Hypophosphatemia
Infection

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

Jan 2018

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

Jan 26, 2018Actual

Primary Completion Date

Apr 9, 2018Actual

Completion Date

Apr 9, 2018Actual

First Submitted Date

Apr 25, 2018

First Submission Date that Met QC Criteria

Nov 12, 2018

First Posted Date

Nov 14, 2018Actual

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

Nov 22, 2018

Last Update Posted Date

Nov 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Retrospective study in the surgical intensive care unit of the Brest Teaching Hospital (France) during a 6-months period (January 2015 -May 2015) to study the independent association between hypophosphatemia and 28-day infection.

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

264Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with sepsis within 28 days after ICU admission	Sepsis was defined according to the criteria of the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).	28 days since the ICU admission

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults

Exclusion Criteria:

Less than 18 years old
Infected at admission

Accepts Healthy Volunteers

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

All patients admitted to 15-bed surgical ICU between January 1, 2015 and June 31, 2015 were screened for inclusion.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest		29609	France

Condition Browse Module

MeSH Terms

ID	Term
D017674	Hypophosphatemia
D007239	Infections

Ancestor Terms

ID	Term
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided