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临床试验/NCT02618707
NCT02618707已完成不适用

Changes of Lactate Levels During Cardiopulmonary Bypass in Pediatric Undergoing Cardiac Surgery: Possible Early Marker of Morbidity and Mortality

Assiut University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Serum lactate during CPB

研究概览

简要总结

Many variables measured in critically ill patients have been used to estimate severity of disease, prognosticate morbidity and mortality, evaluate costs of treatment, and finally indicate specific treatment and monitor the adequacy of treatment and its timing. It is unlikely that one measurement can replace all of these, but in the remainder of this manuscript the investigators will show that lactate levels may come close. Although in our mind strongly linked to tissue hypoxia, lactate levels follow many more metabolic processes not related to tissue hypoxia and, therefore, subject to many disturbances found in various clinical situations

详细描述

Forty consecutive pediatric patients who required cardiopulmonary bypass for repair or palliation of complex congenital heart disease will be enrolled in this study. Patients for the study were selected by convenience sampling, without randomization or control of surgical procedure, conduct of anesthesia, or CPB management.

Patients will be monitored intra-operatively using ECG, invasive and non-invasive blood pressure monitoring, pulse oximetry and capnography for determination of End Tidal Co2 ( ETCo2 ) and nasopharyngeal temperature. After induction of anesthesia and placement of an intra-arterial catheter 1 ml of arterial blood will collected into a heparinized 3 ml blood gas syringe and immediately analyzed on the arterial blood gas analyzer (GEM Premier 3000) for blood gas, hematocrit, electrolytes, calcium and glucose. Management strategy of cardio-pulmonary bypass (CPB) was standardized for all the patients. Lactate samples will drawn at specific time points within 5 time intervals: before CPB after induction, during cooling on CPB, during rewarming on CPB, immediately after CPB in the operating room, and after admission to the post-operative intensive care unit.

Differences in lactate levels related to diagnosis will examined. To examine the effect of patient diagnosis and surgical risk on serum lactate level and outcome, the investigators separated patients into surgical risk categories Risk adjustment for congenital heart surgery (RACHS-1). This classification does not include heart transplantation. Patient mortality and the prevalence of postoperative complications for each of the 3 surgical risk categories relative to the change in lactate will examined.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
12 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age range (1-12 years)
  • Usage of cardiopulmonary bypass

排除标准

  • chest problems
  • Renal problems
  • Hepatic problems

结局指标

主要结局

Serum lactate during CPB

时间窗: first 24 hours

lactate value (mmol/L)

次要结局

未报告次要终点

研究者

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

Sayed Kaoud Abd-Elshafy

Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Assiut University

研究点 (1)

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