Surgery-ComplicationsNCT05834257
Crystalloid Fluids and Cardiac Surgery
A study testing Normal Saline for fluid resuscitation, PlasmaLyte for fluid resuscitation and Ringer's Lacatate for fluid resusciation in people with Surgery-Complications, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
All cardiac patients admitted to the intensive care unit after surgery received crystalloid fluids as standard care procedure. 3 crystalloid fluids can be used during their stay: Normal Saline, PlasmaLyte or Ringer's Lactate. They differ in their respective composition, mainly in chloride and sodium concentrations. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Surgery-Complications
- What is being tested?
- Normal Saline for fluid resuscitation, PlasmaLyte for fluid resuscitation and Ringer's Lacatate for fluid resusciation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 31 Mar 2023to 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patient for coronary artery bypass surgery with CPB (Cardiopulmonary bypass)
Who cannot join
- use of immunomodulating medication 6 months before surgery
- chemiotherapy/radiotherapy 6 months before surgery
- history of neoplasia
- auto-immune disorders
- pregnancy
- severe infection 1 month before surgery
Show all 14Show fewer
- renal/hepatic failure
- left ventricular ejection fraction <40%
- hepatitis C or HIV
- symptomatic peripheral vascular diseases
- chronic obstructive pulmonary disease
- cerebrovascular accident
- hemoglobin <90g/L
- leukocytes <6 or >12x10e6/L
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0C1
About this study
Official title: Study on the Modulation of Inflammation by Crystalloid Fluids in Cardiac Surgery Patients
All cardiac patients admitted to the intensive care unit after surgery received crystalloid fluids as standard care procedure. 3 crystalloid fluids can be used during their stay: Normal Saline, PlasmaLyte or Ringer's Lactate. They differ in their respective composition, mainly in chloride and sodium concentrations. Inflammatory consequences of the crystalloid fluids used in this population are unknown. The investigators plan to evaluate which one of the three fluids mentioned above is advantageous in cardiac surgery patients with regards to reduced rate of infection and renal failure.
Read the detailed description
Inflamed patients admitted to the intensive care unit after cardiac surgery received large volumes of crystalloid fluids as standard care procedure. The goal is to control the balance between the initial pro-inflammatory phase and the subsequent/compensatory anti-inflammatory phase, the later being associated to immune fatigue and the apparition or re-activation of infections. Infectious complications are responsible for the increased rate of morbidity and mortality in this cardiac surgery population. The inflammatory impacts of each of the crystalloid fluids administered to the patient are still ill-defined and represent an opportunity to better control the hyperinflammation and/or immunosuppression often observed following cardiac surgery. Hence, the investigators will evaluate the activation of the immune system following crystalloid fluid (either Normal saline (NS), PlasmaLyte (PL) or Ringer's Lactate (RL)) administration in this population with regard to one recurrent clinical issue, i.e renal failure.
The hypothesis is that LR is less ''immuno-activator'' on monocytes than NS and PL. The objectives are: 1-evaluate the inflammatory profiles of each of the crystalloid fluids in consent cardiac surgery patients during their stay in the intensive care unit by studying white blood cell phenotypes and inflammatory cytokines present in plasma and 2-evaluate the impacts of crystalloid fluids in vitro using white blood cell from cardiac surgery patients obtained before surgery.
- Conditions
- Surgery-Complications
- Being tested
- Normal Saline for fluid resuscitation, PlasmaLyte for fluid resuscitation, Ringer's Lacatate for fluid resusciation
- Keywords
- cardiac surgery, renal failure
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline for fluid resuscitationProcedure or surgery
Fluid resuscitation is a critical and essential part in cardiac surgery procedures. Patients randomized for this arm will be submitted to Normal Saline infusion (as clinically prescribed).
PlasmaLyte for fluid resuscitationProcedure or surgery
Fluid resuscitation is a critical and essential part in cardiac surgery procedures. Patients randomized for this arm will be submitted to PlasmaLyte infusion (as clinically prescribed).
Ringer's Lacatate for fluid resusciationProcedure or surgery
Fluid resuscitation is a critical and essential part in cardiac surgery procedures. Patients randomized for this arm will be submitted to Ringer's Lactate infusion (as clinically prescribed).
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Experimental | 5 Cardiac surgery patients admitted to the intensive care units will receive, following consent and randomisation, Normal Saline as resuscitation fluid. 50mL of blood will be withdrawn before surgery and 24 hours after for each patient in order to isolate neutrophils and monocytes. Plasma will be preserved for future cytokines characterization. Receives: Procedure: Normal Saline for fluid resuscitation |
| PlasmaLyte | Experimental | 5 Cardiac surgery patients admitted to the intensive care units will receive, following consent and randomisation, PlasmaLyte as resuscitation fluid. 50mL of blood will be withdrawn before surgery and 24 hours after for each patient 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 | 5 Cardiac surgery patients admitted to the intensive care units will receive, following consent and randomisation, Ringer's lactate as resuscitation fluid. 50mL of blood will be withdrawn before surgery and 24 hours after for each patient in order to isolate neutrophils and monocytes. Plasma will be preserved for future cytokines characterization. Receives: Procedure: Ringer's Lacatate for fluid resusciation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in monocyte phenotype before and after cardiac surgery
Using white blood cells from patients, the investigators will evaluate CD14/16 expression on monocytes by flow cytometry before and after infusion of crystalloid fluids. Results will be presented as percentage of positive cells.
Measured: 24 hours
Secondary outcomes (2)
Sequential Organ Failure Assessment (SOFA) score after cardiac surgery
will be evaluated by the clinical team. Scale range is 0 (normal, best outcome) to 24 (abnormal, worse outcome).
Measured: 48 hours
Length of stay in intensive care unit after cardiac surgery
will be monitored by the clinical team
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start31 Mar 2023
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Why it stopped: Lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery-ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François Cailhier, MD, Principal investigator, CRCHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834257
- Sponsor's protocol ID
- 15.167
- Status last verified
- Feb 2025
- First submitted
- 4 Apr 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: as mentioned below. Patient names won't be available.
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
- Study on the Modulation of Inflammation by Crystalloid Fluids in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT05834257
- Acronym / sponsor ID
- 15.167
- Conditions
- Surgery-Complications
- Keywords
- cardiac surgery, renal failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 28 Apr 2023 (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.
All cardiac patients admitted to the intensive care unit after surgery received crystalloid fluids as standard care procedure. 3 crystalloid fluids can be used during their stay: Normal Saline, PlasmaLyte or Ringer's Lactate. They differ in their respective composition, mainly in chloride and sodium concentrations. Inflammatory consequences of the crystalloid fluids used in this population are unknown. The investigators plan to evaluate which one of the three fluids mentioned above is advantageous in cardiac surgery patients with regards to reduced rate of infection and renal failure.
Detailed description
Inflamed patients admitted to the intensive care unit after cardiac surgery received large volumes of crystalloid fluids as standard care procedure. The goal is to control the balance between the initial pro-inflammatory phase and the subsequent/compensatory anti-inflammatory phase, the later being associated to immune fatigue and the apparition or re-activation of infections. Infectious complications are responsible for the increased rate of morbidity and mortality in this cardiac surgery population. The inflammatory impacts of each of the crystalloid fluids administered to the patient are still ill-defined and represent an opportunity to better control the hyperinflammation and/or immunosuppression often observed following cardiac surgery. Hence, the investigators will evaluate the activation of the immune system following crystalloid fluid (either Normal saline (NS), PlasmaLyte (PL) or Ringer's Lactate (RL)) administration in this population with regard to one recurrent clinical issue, i.e renal failure.
The hypothesis is that LR is less ''immuno-activator'' on monocytes than NS and PL. The objectives are: 1-evaluate the inflammatory profiles of each of the crystalloid fluids in consent cardiac surgery patients during their stay in the intensive care unit by studying white blood cell phenotypes and inflammatory cytokines present in plasma and 2-evaluate the impacts of crystalloid fluids in vitro using white blood cell from cardiac surgery patients obtained before surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Experimental | Procedure: Normal Saline for fluid resuscitation5 Cardiac surgery patients admitted to the intensive care units will receive, following consent and randomisation, Normal Saline as resuscitation fluid. 50mL of blood will be withdrawn before surgery and 24 hours after for each patient in order to isolate neutrophils and monocytes. Plasma will be preserved for future cytokines characterization. |
| PlasmaLyte | Experimental | Procedure: PlasmaLyte for fluid resuscitation5 Cardiac surgery patients admitted to the intensive care units will receive, following consent and randomisation, PlasmaLyte as resuscitation fluid. 50mL of blood will be withdrawn before surgery and 24 hours after for each patient in order to isolate neutrophils and monocytes. Plasma will be preserved for future cytokines characterization. |
| Ringer's Lactate | Experimental | Procedure: Ringer's Lacatate for fluid resusciation5 Cardiac surgery patients admitted to the intensive care units will receive, following consent and randomisation, Ringer's lactate as resuscitation fluid. 50mL of blood will be withdrawn before surgery and 24 hours after for each patient in order to isolate neutrophils and monocytes. Plasma will be preserved for future cytokines characterization. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- patient for coronary artery bypass surgery with CPB (Cardiopulmonary bypass)
Key exclusion criteria (14 listed)
- use of immunomodulating medication 6 months before surgery
- chemiotherapy/radiotherapy 6 months before surgery
- history of neoplasia
- auto-immune disorders
- pregnancy
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 |
|---|---|---|
| Normal Saline for fluid resuscitationFluid resuscitation is a critical and essential part in cardiac surgery procedures. Patients randomized for this arm will be submitted to Normal Saline infusion (as clinically prescribed). | Procedure or surgery | Normal Saline |
| PlasmaLyte for fluid resuscitationFluid resuscitation is a critical and essential part in cardiac surgery procedures. Patients randomized for this arm will be submitted to PlasmaLyte infusion (as clinically prescribed). | Procedure or surgery | PlasmaLyte |
| Ringer's Lacatate for fluid resusciationFluid resuscitation is a critical and essential part in cardiac surgery procedures. 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 before and after cardiac surgery
Time frame: 24 hours
Using white blood cells from patients, the investigators will evaluate CD14/16 expression on monocytes by flow cytometry before and after infusion of crystalloid fluids. Results will be presented as percentage of positive cells.
2 secondary outcomes
Sequential Organ Failure Assessment (SOFA) score after cardiac surgery
Time frame: 48 hours
Length of stay in intensive care unit after cardiac surgery
Time frame: up to 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: Yes. as mentioned below. Patient names won't be available.
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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 Normal Saline for fluid resuscitation, PlasmaLyte for fluid resuscitation and Ringer's Lacatate for fluid resusciation in people with Surgery-Complications, 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 1 inclusion and 14 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: withdrawn, 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 withdrawn before enrolling participants, so there are no results.
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 before and after cardiac surgery (time frame: 24 hours). 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.