Crystalloid Fluids and Cardiac Surgery
Study on the Modulation of Inflammation by Crystalloid Fluids in Cardiac Surgery Patients
Study Overview
Status
Conditions
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 0C1
- Centre Hospitalier de l'Universite de Montreal (CHUM)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patient for coronary artery bypass surgery with CPB (Cardiopulmonary bypass)
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Normal Saline
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.
|
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).
|
|
Experimental: PlasmaLyte
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.
|
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).
|
|
Experimental: Ringer's Lactate
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sequential Organ Failure Assessment (SOFA) score after cardiac surgery
Time Frame: 48 hours
|
will be evaluated by the clinical team.
Scale range is 0 (normal, best outcome) to 24 (abnormal, worse outcome).
|
48 hours
|
|
Length of stay in intensive care unit after cardiac surgery
Time Frame: up to 4 weeks
|
will be monitored by the clinical team
|
up to 4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean-François Cailhier, MD, CRCHUM
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15.167
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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