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临床试验/NCT04254744
NCT04254744已完成不适用

Systemic Inflammatory Response Syndrome Cyanotic and Acyanotic Children Undergoing Cardiac Surgery

Cukurova University1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2020年2月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
197
试验地点
1
主要终点
White blood cell count

研究概览

简要总结

Systemic inflammatory response syndrome (SIRS) is frequently observed in children after open-heart surgery and has been associated with both cardiopulmonary bypass and surgical trauma. Children with congenital cyanotic heart disease (CCHD) have complex changes in all blood values and clotting profiles due to chronic hypoxemia. Increased erythrocyte count decreases plasma and coagulation factors, platelet count and function. Therefore, blood and blood products transfusion may increase during intraoperative and postoperative periods. In addition, durations of cardiopulmonary bypass may prolong due to the complex defects of children with CCHD. The aim of this study is to investigate postoperative SIRS rates and risk factors in cyanotic and acyanotic children undergoing open heart surgery for congenital heart disease.

详细描述

Systemic inflammatory response syndrome (SIRS) in adults has been defined as a non-specific systemic inflammatory process in the absence of infection, following incidents such as trauma, burns, pancreatitis, or major surgery. For children, age-specific SIRS criteria were established by the International Pediatric Sepsis Consensus Conference in 2005. SIRS was defined as presence of at least two out of four parameters, one of which must be an abnormal temperature or leukocyte count. The two other criteria consist of either an elevated heart rate or respiratory rate. SIRS is frequently observed in children after open-heart surgery and has been associated with both cardiopulmonary bypass and surgical trauma. Following cardiac surgery the pathophysiological mechanisms of SIRS involve a cytokine-mediated general capillary leakage followed by intravascular volume depletion, generalized edema, circulatory compromise, and altered microcirculation. The inflammatory process may further impair the function of the lung, myocardium, kidney, liver, intestine, and brain.

Children with congenital cyanotic heart disease (CCHD) have complex changes in all blood values and clotting profiles due to chronic hypoxemia. Increased erythrocyte count decreases plasma and coagulation factors, platelet count and function. Therefore, blood and blood products transfusion may increase during intraoperative and postoperative periods. In addition, durations of cardiopulmonary bypass may prolong due to the complex defects of children with CCHD. Previous studies have reported that the duration of CPB and the amount of fresh frozen plasma transfusion increase SIRS formation.

The aim of this study is to investigate postoperative SIRS rates and risk factors in cyanotic and acyanotic children undergoing open heart surgery for congenital heart disease.

Patients aged between 0-16 years and undergoing open heart surgery for cyanotic and acyanotic congenital heart disease will be included in the study. Patients with preoperative renal failure or hepatic disease will be excluded. Patient's age, weight, comorbidities, details of previous operation will be recorded. Preoperative hematocrit value, white blood cell and platelet counts, biochemical parameters (blood urea nitrogen, creatinine, electrolyte values), diagnosis of CCHD, RACHS1 (risk adjustment for surgery for congenital heart disease) will be recorded. In intraoperative period; operation time, CPB time, aortic cross-clamp time, circulatory arrest time, body temperature and lowest body temperature reached during CPB, cardioplegia amount, The ACT (activated coagulation time), urine amount will be recorded. Intraoperative blood gas values, lactate, mean arterial pressure, glucose values will be recorded at 30 min intervals. The amount of crystalloid and colloid, erythrocyte, fresh frozen plasma, platelet and cryoprecipitate used in intraoperative period will be recorded. Heparin and protamine doses administered will be recorded. Vasoactive agents (dopamine, dobutamine, adrenaline, nitroglycerine) used in intraoperative period will be recorded.

During the postoperative intensive care period; arterial blood gases and lactate, hematocrit, liquid (crystalloid and colloid) and blood products administered will be monitored at 6th, 24th and 48th hours. The vasoactive agents used, the inotropic score, the amount of urine and the use of diuretics will be recorded. Length of stay ICU, duration of mechanical ventilation, length of stay hospital will be recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 0-16 years
  • undergoing open heart surgery for cyanotic and acyanotic congenital heart disease

排除标准

  • Patients with preoperative renal failure
  • Patients with preoperative hepatic disease
  • Patients with preoperative inflammatory disease
  • Patients using anti-inflammatory drug

研究组 & 干预措施

Acyanotic children

Acyanotic children undergoing cardiac surgery due to congenital heart disease

干预措施: Sevoflurane (Drug)

Cyanotic children

Cyanotic children undergoing cardiac surgery due to congenital heart disease

干预措施: Sevoflurane (Drug)

结局指标

主要结局

White blood cell count

时间窗: 48 hours after arrival in Intensive care unit

heart rate

时间窗: 48 hours after arrival in Intensive care unit

body temperature

时间窗: 48 hours after arrival in Intensive care unit

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

Feride Karacaer

Associated professor

Cukurova University

研究点 (1)

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