Clinical trial NCT05834257: Crystalloid Fluids and Cardiac Surgery
Official title: Study on the Modulation of Inflammation by Crystalloid Fluids in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Surgery-Complications
Keywords: cardiac surgery
renal failure
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in monocyte phenotype before and after cardiac surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Sequential Organ Failure Assessment (SOFA) score after cardiac surgery
timeFrame: 48 hours
measure: Length of stay in intensive care unit after cardiac surgery
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: CRCHUM
name: Jean-François Cailhier, MD
role: PRINCIPAL_INVESTIGATOR
References: