Crystalloid Fluids and Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study on the Modulation of Inflammation by Crystalloid Fluids in Cardiac Surgery Patients

Conditions
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Surgery-Complications

Intervention / Treatment
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* Other: Crystalloid fluid infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Saline group<br>Randomised patients with consent that will received Normal Saline as crystalloid fluid | Other: Crystalloid fluid infusion<br>* Cardiac surgery patients admitted to the intensive care units will either receive, following consent and randomisation, Normal Saline, PlasmaLyte or Ringer's Lactate as resuscitation fluid. 50mL of blood will be withdrawn before surgery and 24 hours after for each patient enrolled in the study.<br>|
| Active Comparator: PlasmaLyte group<br>Randomised patients with consent that will received PlasmaLyte as crystalloid fluid | Other: Crystalloid fluid infusion<br>* Cardiac surgery patients admitted to the intensive care units will either receive, following consent and randomisation, Normal Saline, PlasmaLyte or Ringer's Lactate as resuscitation fluid. 50mL of blood will be withdrawn before surgery and 24 hours after for each patient enrolled in the study.<br>|
| Active Comparator: Ringer's Lactate group<br>Randomised patients with consent that will received Ringer's Lactate as crystalloid fluid | Other: Crystalloid fluid infusion<br>* Cardiac surgery patients admitted to the intensive care units will either receive, following consent and randomisation, Normal Saline, PlasmaLyte or Ringer's Lactate as resuscitation fluid. 50mL of blood will be withdrawn before surgery and 24 hours after for each patient enrolled in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocyte activation | 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 score | will be evaluated by the clinical team. Scale range is 0 (normal, best outcome) to 24 (abnormal, worse outcome). | 48 hours | 
| Presence of infections | will be monitored by the clinical team | up to 4 weeks | 
| Length of stay in intensive care unit | will be monitored by the clinical team | up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, renal failure