Pilot Study to Measure Uric Acid in Traumatized Patients:... | NCT03622632

Studies
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association

NCT03622632

Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Status

Unknown status

Last Update Posted

Feb 18, 2020Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Trauma
Inflammation

Interventions

Not provided

Countries

Canada

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

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2018Actual

Primary Completion Date

Aug 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Jul 24, 2018

First Submission Date that Met QC Criteria

Aug 7, 2018

First Posted Date

Aug 9, 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

Feb 16, 2020

Last Update Posted Date

Feb 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emmanuel Charbonney, MD PhD, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealPrincipal Investigator

Lead Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealOTHER

Collaborators

Name	Class
Fonds de la Recherche en Santé du Québec	OTHER_GOV

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

The goal of this project, is to better understand the fluctuation of the level of uric acid in traumatized patients by making serial measurements during their hospitalization in the intensive care unit. In addition, the determinants (e.g. type of trauma, diseases, interventions) of the blood level of uric acid and its association with the development of organ failure will be sought.

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

25Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of serial plasmatic uric acid sampling after trauma	Number of measures collected/number of measures planned	7 days

Secondary Outcomes

Measure	Description	Time Frame
Impact of resuscitation on uric acid measures	Impact of fluid administration (amount in mL) on the changes of subsequent uric acid blood level	24 to 48 hours
Clinical predictors of the first blood uric acid (μmol/L) level measured

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Direct admission to trauma center
≤ 3h after trauma
ISS ≥ 16
Received at least 1L of fluid at ER entrance

Exclusion Criteria:

Isolated head injury
Isolated spine injury
Chemotherapy within the last month
Hematologic disease
Chronic hemodialysis
Uricase treatment within the last week
Expected death within 48h

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

Multiple trauma patients admitted in the trauma center and requiring ICU admission.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital du Sacré-Cœur de Montréal		Montreal	Quebec	H4J1C5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D007249	Inflammation

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Impact of patient's characteristics and physiological variables on the first measured blood uric acid.

Characteristics will include: age (years), gender, Injury severity score, presence of acute renal impairment.

Physiological variables will include: lower systolic blood pressure, base deficit, lactate level