Crystalloid Fluids and Cardiac Surgery

NCT ID: NCT05834257

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2025-02-19

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.

Conditions

Surgery-Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Normal Saline for fluid resuscitation

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

PlasmaLyte for fluid resuscitation

Intervention Type: PROCEDURE

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 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.

Group Type: EXPERIMENTAL

Ringer's Lacatate for fluid resusciation

Intervention Type: PROCEDURE

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).

Interventions

Normal Saline for fluid resuscitation

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).

Intervention Type: PROCEDURE

PlasmaLyte for fluid resuscitation

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).

Intervention Type: PROCEDURE

Ringer's Lacatate for fluid resusciation

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).

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-François Cailhier, MD

Role: PRINCIPAL_INVESTIGATOR

CRCHUM

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

15.167

Identifier Type: -

Identifier Source: org_study_id