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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Trauma

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4J1C5
      • Hôpital du Sacré-Coeur de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	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	12 hours

Collaborators and Investigators

• Sponsor: Hopital du Sacre-Coeur de Montreal
• Collaborators: Fonds de la Recherche en Santé du Québec

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2018
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 16, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: uric acid; organ failure
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 263425

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No