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Crystalloid Fluids and Cardiac Surgery

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05834257
Enrollment
0
Registered
2023-04-28
Start date
2023-03-31
Completion date
2025-02-19
Last updated
2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery-Complications

Keywords

cardiac surgery, renal failure

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.

Interventions

PROCEDURENormal 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).

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).

PROCEDURERinger'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).

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in monocyte phenotype before and after cardiac surgery24 hoursUsing 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

MeasureTime frameDescription
Sequential Organ Failure Assessment (SOFA) score after cardiac surgery48 hourswill 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 surgeryup to 4 weekswill be monitored by the clinical team

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026