Crystalloid Fluids and Cardiac Surgery

Not Applicable

Withdrawn

• Conditions: Surgery-Complications
• Interventions: Procedure: Ringer's Lacatate for fluid resusciation; Procedure: PlasmaLyte for fluid resuscitation; Procedure: Normal Saline for fluid resuscitation

• Registration Number: NCT05834257
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Timeline

• Study Start: 2023-03-31
• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-28
• Status Verified: 2025-02
• Primary Completion: 2025-02-19
• Study Completion: 2025-02-19
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer's Lactate	Ringer's Lacatate for fluid resusciation	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.
PlasmaLyte	PlasmaLyte for fluid resuscitation	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.
Normal Saline	Normal Saline for fluid resuscitation	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.

Primary Outcome Measures

Name	Time	Method
Change in monocyte phenotype before and after cardiac surgery	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.

Secondary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment (SOFA) score after cardiac surgery	48 hours	will be evaluated by the clinical team. Scale range is 0 (normal, best outcome) to 24 (abnormal, worse outcome).
Length of stay in intensive care unit after cardiac surgery	up to 4 weeks	will be monitored by the clinical team

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montreal, Quebec, Canada