跳至主要内容
临床试验/NCT05834257
NCT05834257撤回不适用

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

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年3月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
15
试验地点
1
主要终点
Change in monocyte phenotype before and after cardiac surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Normal Saline for fluid resuscitation (Procedure)

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.

干预措施: PlasmaLyte for fluid resuscitation (Procedure)

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.

干预措施: Ringer's Lacatate for fluid resusciation (Procedure)

结局指标

主要结局

Change in monocyte phenotype before and after cardiac surgery

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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