Prognostic Value of Neutrophil-Lymphocyte Ratio (NLR), Absolute Lymphocyte Count (ALC), and Thrombocyte-Lymphocyte Ratio (TLR) in Predicting the Outcomes of Tetralogy of Fallot Primary Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- Number of Patients Requiring Redo surgery
研究概览
简要总结
Tetralogy of Fallot (ToF) were cyanotic congenital heart disease with chronic hypoxia which increases the risk of exacerbated inflammatory response in ToF primary repair. Various studies have recently shown inflammatory biomarkers to predict morbidity and mortality in hypoxemic patients, but they are not readily available and expensive.This study aims to compare the prognostic value of neutrophil-lymphocyte ratio (NLR), absolute lymphocyte count (ALC), and thrombocyte-lymphocyte ratio (TLR) in predicting ToF primary repair outcomes. This was a retrospective observational study on ToF primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022. Preoperative NLR, ALC, and TLR were derived from blood test obtained <14 days before surgery. The primary endpoints were redo surgery, 30-day mortality, and complications. The secondary endpoints were hospital length of stay (HLOS) and postoperative LOS.
详细描述
This was a retrospective observational study on tetralogy of Fallot (ToF) primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022. The preoperative demographic data included were patients' gender, age, weight, oxygen saturation, and associated diagnosis other than ToF. The preoperative data of complete blood count and differential count must be tested from the most recent peripheral blood samples taken no later than 14 days before the surgery. The data obtained were the number of days of the most recent blood test including the leukocyte count, percentage neutrophil, percentage and absolute lymphocyte count, thrombocyte count, as well as the derived variables such as neutrophil lymphocyte ratio (NLR) ratio and thrombocyte lymphocyte ratio (TLR). The intraoperative data included were the use of cardiopulmonary bypass (CPB), CPB time, aortic cross-clamp (AOX) time, and the total duration of surgery. Patients were evaluated and followed-up for any complications and postoperative mortality during the same hospital stay until discharge. Patients were then followed up for any cause of mortality within 30 days postoperative.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with ToF and any other associated cardiac anomalies, who underwent ToF primary repair and had a complete blood cell count with differential count available preoperatively
排除标准
- •Surgery other than ToF primary repair
- •Association with other procedures (except patent ductus arteriosus/PDA ligation, patent foramen ovale/PFO or atrial septal defect/ASD closure, or pulmonary arteries enlargement)
- •Preoperative hemodynamic instability
- •Suspected or confirmed infection with prior antibiotic administration during the same hospital admission
- •Absence of complete blood count with differential count
结局指标
主要结局
Number of Patients Requiring Redo surgery
时间窗: From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first
Redo surgery was defined as additional or corrective surgery after the initial primary ToF repair within the same hospital admission.
Mortality
时间窗: Until 30 days postoperative
Mortality intraoperative or postoperative
Complications (categorized as mild, moderate, severe)
时间窗: From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first
Complication was defined as any adverse events that arised during the operation or postoperative until the discharge of the patient.
次要结局
- Postoperative Length of Stay(From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first)
- Hospital Length of Stay(From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first)
研究者
Sisca Natalia Siagian
Principal Investigator
National Cardiovascular Center Harapan Kita Hospital Indonesia