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临床试验/NCT07034716
NCT07034716尚未招募不适用

Effects Of Pulsatile and Non-Pulsatile Cardiopulmonary Bypass Flow On Predictors Of Outcome After Coronary Artery Bypass Graft Surgery

Alexandria University0 个研究点目标入组 60 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
effects of pulsatile versus non-pulsatile perfusion methods in CABG surgeries on arterial lactate level.

研究概览

简要总结

In cardiac operations, high values of blood lactate have been associated with bad outcomes if detected both during CPB and at the arrival in the intensive care unit (ICU) in adult patients. Many studies highlighted the potential role of hyperlactatemia on admission to the ICU as a marker for adverse outcome, and one study linked hyperlactatemia during CPB with postoperative morbidity and mortality. Evidence that both CENTRAL VENOUS SATURATION (ScVO2) and blood lactates during CPB are potential early predictors of morbidity and mortality in adult cardiac operations are still lacking.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •cardiac surgical patients who will undergo isolated elective CABG and fulfill these criteria:
  • •Aged 18 years or above.
  • •Operated with cardiopulmonary bypass.

排除标准

  • •Preoperative lactate level greater than 3 mmol/l.
  • •Redo surgery.
  • •If the patient will be reoperated during the study time.
  • •Preoperative hemoglobin level less than 10 mg/dl.
  • •Ejection fraction (EF) of <30%.
  • •Renal impairment.
  • •Liver impairment.
  • •History of stroke and significant carotid artery stenosis.
  • •Chronic obstructive or restrictive lung disease.

研究组 & 干预措施

Group (P): Pulsatile flow will be used during CPB

Experimental

Pulsatile flow will be used during CPB

干预措施: cardiac surgical patients who will undergo isolated elective cardiopulmonary bypass (Procedure)

Group NP: non-pulsatile perfusion.

Active Comparator

non-pulsatile perfusion during CARDIOPULMONARY BYPASS

干预措施: CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASS (Procedure)

结局指标

主要结局

effects of pulsatile versus non-pulsatile perfusion methods in CABG surgeries on arterial lactate level.

时间窗: 24 hour

Arterila Lactate values (mmol/L).

effects of pulsatile versus non-pulsatile perfusion methods in CABG surgeries on saturation of central venous blood.

时间窗: 24 hour

saturation of central venous blood (percentage)

次要结局

  • Length of ICU stay (days)(24 hour)
  • The duration of mechanical ventilation (hours).(24 hour)
  • Occurrence of major morbidity(72 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Islam Elbardan

Lecture of anesthesia and surgical intensive care

Alexandria University

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