BurnsNCT04893382
Inflammatory Consequences of Crystalloids in Severely Burned Patients
A study testing PlasmaLyte for fluid resuscitation and Ringer's Lactate for fluid resuscitation in people with Burns, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This is a pilot study, but the investigators will also observe key immunological events with potential significance. The global objective is to study the inflammatory profiles of PlasmaLyte and Ringer's Lactate used in the initial massive fluid resuscitation of severely burned patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- PlasmaLyte for fluid resuscitation and Ringer's Lactate for fluid resuscitation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 17 Oct 2021to 19 Feb 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admission to the CHUM
- more than 20% of burned area
- first blood withdrawal in the first 24 hours following burn
Who cannot join
- immunosuppression
- chemotherapy 6 months before admission
- radiotherapy 6 months before admission
- autoimmune diseases
- neoplasia
- pregnancy
Show all 12Show fewer
- severe infections
- cardiac dysfunctions
- renal dysfunction
- hepatic dysfunctions
- Hepatitis C
- HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deciphering the Inflammatory Consequences of Crystalloids Used in the Resuscitation of Severely Burned Patients
This is a pilot study, but the investigators will also observe key immunological events with potential significance. The global objective is to study the inflammatory profiles of PlasmaLyte and Ringer's Lactate used in the initial massive fluid resuscitation of severely burned patients. On the long term, the investigators will identify the crystalloid that prevents hyperactivation of macrophages and death of severely burned patients.
Read the detailed description
The investigators have 4 specific objectives. First, the investigators will compare the activation profiles of macrophages and neutrophils in patients admitted to the severely burned unit with regards to the crystalloids used. Secondly, the investigators will assess the differences in the SOFA scores according to the crystalloids used. Thirdly, the investigators will evaluate the impact of crystalloids in the quality of skin grafts performed on severely burned patients. Lastly, with the help of a patient partner, the investigators will determine the right immunological terminology of the study for a non-scientific population.
- Conditions
- Burns
- Being tested
- PlasmaLyte for fluid resuscitation, Ringer's Lactate for fluid resuscitation
- Keywords
- Resuscitation, Crystalloids, Inflammation
- Medical subject headings
- Burns, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmaLyte for fluid resuscitationProcedure or surgery
Fluid resuscitation is a critical and essential part in the treatment of severely burned patients. Patients randomized for this arm will be submitted to PlasmaLyte infusion (as clinically prescribed).
Ringer's Lactate for fluid resuscitationProcedure or surgery
Fluid resuscitation is a critical and essential part in the treatment of severely burned patients. Patients randomized for this arm will be submitted to Ringer's Lactate infusion (as clinically prescribed).
| Study group | Role | What they receive |
|---|---|---|
| PlasmaLyte | Experimental | Seven (7) severely burned patients will be infused with PlasmaLyte (following randomization) during the resuscitation period following admission to the ICU. 50mL of blood will be withdrawn before the first infusion and for the following days (Day 1-2-5 and 10) in order to isolate neutrophils and monocytes. Plasma will be preserved for future cytokines characterization. Receives: Procedure: PlasmaLyte for fluid resuscitation |
| Ringer's Lactate | Experimental | Seven (7) severely burned patients will be infused with Ringer's Lactate (following randomization) during the resuscitation period following admission to the ICU. 50mL of blood will be withdrawn before the first infusion and for the following days (Day 1-2-5 and 10) in order to isolate neutrophils and monocytes. Plasma will be preserved for future cytokines characterization. Receives: Procedure: Ringer's Lactate for fluid resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in monocyte phenotype from admission to day 10
Following blood draws, monocytes will be subjected to flow cytometry for phenotype evaluation.
Measured: Pre-infusion to day 10 post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start17 Oct 2021
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Why it stopped: Lack of funds and participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients admitted to the severely burned unit will be randomized by the research nurse to either received PlasmaLyte or Ringer's Lactate. Research Nurse will then advise the treating team.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François Cailhier, MD, Principal investigator, CRCHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893382
- Sponsor's protocol ID
- 20.443
- Status last verified
- Feb 2025
- First submitted
- 12 May 2021
- Last updated
- 21 Feb 2025
- 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 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Inflammatory Consequences of Crystalloids Used in the Resuscitation of Severely Burned Patients
- ClinicalTrials.gov ID
- NCT04893382
- Acronym / sponsor ID
- 20.443
- Conditions
- Burns
- Keywords
- Resuscitation, Crystalloids, Inflammation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funds and participants
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 17 Oct 2021 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 19 May 2021 (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.
This is a pilot study, but the investigators will also observe key immunological events with potential significance. The global objective is to study the inflammatory profiles of PlasmaLyte and Ringer's Lactate used in the initial massive fluid resuscitation of severely burned patients. On the long term, the investigators will identify the crystalloid that prevents hyperactivation of macrophages and death of severely burned patients.
Detailed description
The investigators have 4 specific objectives. First, the investigators will compare the activation profiles of macrophages and neutrophils in patients admitted to the severely burned unit with regards to the crystalloids used. Secondly, the investigators will assess the differences in the SOFA scores according to the crystalloids used. Thirdly, the investigators will evaluate the impact of crystalloids in the quality of skin grafts performed on severely burned patients. Lastly, with the help of a patient partner, the investigators will determine the right immunological terminology of the study for a non-scientific population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients admitted to the severely burned unit will be randomized by the research nurse to either received PlasmaLyte or Ringer's Lactate. Research Nurse will then advise the treating team.
| Arm | Type | Receives |
|---|---|---|
| PlasmaLyte | Experimental | Procedure: PlasmaLyte for fluid resuscitationSeven (7) severely burned patients will be infused with PlasmaLyte (following randomization) during the resuscitation period following admission to the ICU. 50mL of blood will be withdrawn before the first infusion and for the following days (Day 1-2-5 and 10) in order to isolate neutrophils and monocytes. Plasma will be preserved for future cytokines characterization. |
| Ringer's Lactate | Experimental | Procedure: Ringer's Lactate for fluid resuscitationSeven (7) severely burned patients will be infused with Ringer's Lactate (following randomization) during the resuscitation period following admission to the ICU. 50mL of blood will be withdrawn before the first infusion and for the following days (Day 1-2-5 and 10) in order to isolate neutrophils and monocytes. Plasma will be preserved for future cytokines characterization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- admission to the CHUM
- more than 20% of burned area
- first blood withdrawal in the first 24 hours following burn
Key exclusion criteria (12 listed)
- immunosuppression
- chemotherapy 6 months before admission
- radiotherapy 6 months before admission
- autoimmune diseases
- neoplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlasmaLyte for fluid resuscitationFluid resuscitation is a critical and essential part in the treatment of severely burned patients. Patients randomized for this arm will be submitted to PlasmaLyte infusion (as clinically prescribed). | Procedure or surgery | PlasmaLyte |
| Ringer's Lactate for fluid resuscitationFluid resuscitation is a critical and essential part in the treatment of severely burned patients. Patients randomized for this arm will be submitted to Ringer's Lactate infusion (as clinically prescribed). | Procedure or surgery | Ringer's Lactate |
Primary outcome
Change in monocyte phenotype from admission to day 10
Time frame: Pre-infusion to day 10 post-infusion
Following blood draws, monocytes will be subjected to flow cytometry for phenotype evaluation.
Results and safety
The study was stopped early (reason given: Lack of funds and participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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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.
Jean-François Cailhier, MD principal investigator
CRCHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PlasmaLyte for fluid resuscitation and Ringer's Lactate for fluid resuscitation in people with Burns, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 21 Feb 2025. 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?
The study was stopped early (reason given: Lack of funds and participants). 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?
Change in monocyte phenotype from admission to day 10 (time frame: Pre-infusion to day 10 post-infusion). 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 21 Feb 2025.