Crystalloid Fluids and Cardiac Surgery

NCT05834257 | Withdrawn

• 1 other identifier: 15.167
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery-Complications

Keywords

cardiac surgery; renal failure

Outcome Measures

Primary Outcomes (1)

• Change in monocyte phenotype before and after cardiac surgery

  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 Outcomes (2)

• Sequential Organ Failure Assessment (SOFA) score after cardiac surgery

  48 hours

• Length of stay in intensive care unit after cardiac surgery

  up to 4 weeks

Study Arms (3)

Normal Saline

EXPERIMENTAL

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units will receive, following consent and randomisation, Normal Saline as resuscitation fluid. 50mL of blood will be withdrawn before surgery and 24 hours after for each patient in order to isolate neutrophils and monocytes.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.

Procedure: Normal Saline for fluid resuscitation

PlasmaLyte

EXPERIMENTAL

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care units will receive, following consent and randomisation, PlasmaLyte as resuscitation fluid. 50mL of blood will be withdrawn before surgery and 24 hours after for each patient in order to isolate neutrophils and monocytes.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.

Procedure: PlasmaLyte for fluid resuscitation

Ringer's Lactate

EXPERIMENTAL

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units will receive, following consent and randomisation, Ringer's lactate as resuscitation fluid. 50mL of blood will be withdrawn before surgery and 24 hours after for each patient in order to isolate neutrophils and monocytes.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.

Procedure: Ringer's Lacatate for fluid resusciation

Interventions

Normal Saline for fluid resuscitation 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).

Normal Saline

PlasmaLyte for fluid resuscitation 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).

PlasmaLyte

Ringer's Lacatate for fluid resusciation 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).

Ringer's Lactate

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• patient for coronary artery bypass surgery with CPB (Cardiopulmonary bypass)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0C1, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Saline Solution; Plasmalyte A

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jean-François Cailhier, MD

  CRCHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 28, 2023
• Study Start: March 31, 2023
• Primary Completion: February 19, 2025
• Study Completion: February 19, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Following completion of the study and upon demand
• Access Criteria: reasonable request

Locations

CA (1)