TraumaNCT03622632
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
An observational study of Trauma and Inflammation, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Inflammation
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2018to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Multiple trauma patients admitted in the trauma center and requiring ICU admission.
Who may be able to join
- Direct admission to trauma center
- ≤ 3h after trauma
- ISS ≥ 16
- Received at least 1L of fluid at ER entrance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Trauma, Inflammation
- Keywords
- uric acid, organ failure
- Medical subject headings
- Wounds and Injuries, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of serial plasmatic uric acid sampling after trauma
Number of measures collected/number of measures planned
Measured: 7 days
Secondary outcomes (2)
Impact of resuscitation on uric acid measures
Impact of fluid administration (amount in mL) on the changes of subsequent uric acid blood level
Measured: 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
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start30 Sep 2018
- Primary completionAug 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Responsible party
- Principal investigator, Emmanuel Charbonney, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622632
- Sponsor's protocol ID
- 263425
- Status last verified
- Feb 2020
- First submitted
- 24 Jul 2018
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
- ClinicalTrials.gov ID
- NCT03622632
- Acronym / sponsor ID
- 263425
- Conditions
- Trauma, Inflammation
- Keywords
- uric acid, organ failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Multiple trauma patients admitted in the trauma center and requiring ICU admission.
Key inclusion criteria (4 listed)
- Direct admission to trauma center
- ≤ 3h after trauma
- ISS ≥ 16
- Received at least 1L of fluid at ER entrance
Key exclusion criteria (7 listed)
- Isolated head injury
- Isolated spine injury
- Chemotherapy within the last month
- Hematologic disease
- Chronic hemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of serial plasmatic uric acid sampling after trauma
Time frame: 7 days
Number of measures collected/number of measures planned
2 secondary outcomes
Impact of resuscitation on uric acid measures
Time frame: 24 to 48 hours
Clinical predictors of the first blood uric acid (μmol/L) level measured
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Inflammation, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of serial plasmatic uric acid sampling after trauma (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.