Evaluation of the Effect of Perioperative Lidocaine Administration on Reducing Pulmonary Injury in Infants Following Cardiac Surgery: A Randomized, Placebo-Controlled, Double-Blind, Multi-center Superiority Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Acute Lung Injury Score within 72 hours after surgery
研究概览
简要总结
Cardiopulmonary bypass-associated pulmonary injury is a common complication after infant cardiac surgery and may contribute to impaired oxygenation, prolonged mechanical ventilation, and longer intensive care stay. Lidocaine has anti-inflammatory and membrane-stabilizing properties and may attenuate perioperative lung injury. This investigator-initiated, randomized, placebo-controlled, double-blind trial will evaluate whether perioperative intravenous lidocaine reduces postoperative pulmonary injury in infants undergoing corrective non-palliative congenital cardiac surgery with cardiopulmonary bypass.
详细描述
Infants undergoing cardiac surgery with cardiopulmonary bypass are at risk of postoperative pulmonary injury due to systemic inflammatory activation, ischemia-reperfusion injury, and disruption of the alveolar-capillary barrier. Intravenous lidocaine has been reported to exert anti-inflammatory, anti-arrhythmic, and potential organ-protective effects. However, evidence in infants undergoing cardiac surgery remains limited.
This randomized, double-blind, placebo-controlled superiority trial will enroll infants aged 0 to 12 months scheduled for corrective, non-palliative congenital cardiac surgery with cardiopulmonary bypass at a tertiary pediatric center. Participants will be randomized in a 1:1 ratio to receive either perioperative intravenous lidocaine or volume-matched normal saline placebo. The trial will assess postoperative pulmonary injury severity over the first 72 hours after surgery, together with respiratory, laboratory, echocardiographic, and safety outcomes until postoperative day 7 or at discharge.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, parents/guardians, treating clinicians, investigators, and outcome assessors/statisticians will remain blinded to treatment allocation. Study medication will be prepared by designated anesthesia staff not involved in outcome assessment.
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 0 to 12 months.
- •Congenital heart disease requiring corrective, non-palliative cardiac surgery with cardiopulmonary bypass.
- •American Society of Anesthesiologists (ASA) physical status I to III.
- •Written informed consent provided by parent(s) or legal guardian(s).
排除标准
- •Multiple malformations, chromosomal abnormalities, or immunodeficiency.
- •Known or suspected allergy to lidocaine.
- •Concomitant continuous infusion of another local anesthetic.
- •Conditions associated with increased risk of lidocaine accumulation or toxicity, including severe conduction block or severe bradycardia.
- •ASA physical status IV or higher.
- •Severe malnutrition expected to substantially impair postoperative recovery.
- •Severe hepatic or renal dysfunction.
- •Significant pre-existing pulmonary disease or markedly impaired preoperative pulmonary function.
- •Central nervous system disorders that may increase susceptibility to lidocaine neurotoxicity, including epilepsy or prior central nervous system infection.
- •Use of medications that may interact with lidocaine or constitute an exclusion, including class I or class III antiarrhythmic agents, cimetidine, or antiviral drugs, as determined by the clinical team.
- •Current or recent participation in another interventional clinical trial in its active intervention phase.
结局指标
主要结局
Acute Lung Injury Score within 72 hours after surgery
时间窗: Assessed at 0, 12, 24, 36, 48, 60, and 72 hours after surgery
Composite lung injury severity score ranging from 0 to 4, based on oxygenation index or oxygen saturation index, chest radiograph findings, positive en-expiratory pressure, and pulmonary compliance. Higher scores indicate more severe lung injury.
次要结局
- Plasma soluble receptor for advanced glycation end products (sRAGE) concentration(Baseline, 24, 48, and 72 hours after surgery)
- Plasma interleukin-1 beta (IL-1β) concentration(Baseline, 24, 48, and 72 hours after surgery)
- Arterial partial pressure of oxygen(0, 12, 24, 36, 48, 60, and 72 hours after surgery)
- Arterial partial pressure of carbon dioxide(0, 12, 24, 36, 48, 60, and 72 hours after surgery)
- Plasma soluble intercellular adhesion molecule-1 (sICAM-1) concentration(Baseline, 24, 48, and 72 hours after surgery)
- Plasma surfactant protein D (SP-D) concentration(Baseline, 24, 48, and 72 hours after surgery)
- Arterial oxygen saturation(0, 12, 24, 36, 48, 60, and 72 hours after surgery)
- Arterial lactate concentration(0, 12, 24, 36, 48, 60, and 72 hours after surgery)
- Duration of mechanical ventilation(From postoperative ICU admission until successful discontinuation of invasive mechanical ventilation, assessed up to 72 hours after surgery.)
- PICU length of stay(From postoperative admission to the pediatric intensive care unit until discharge from the pediatric intensive care unit, assessed up to 7 days after surgery.)
- Left ventricular ejection fraction (LVEF)(Baseline, 24, 48, and 72 hours after surgery)
- Plasma lidocaine concentration(6, 12, 18, 24 hours after surgery)
- Incidence of postoperative pulmonary complications(Assessed within 72 hours after surgery)
- Prothrombin time (PT)(Baseline, 24, 48, and 72 hours after surgery)
- Activated partial thromboplastin time (aPTT)(Baseline, 24, 48, and 72 hours after surgery)
- Alanine aminotransferase (ALT)(Baseline, 24, 48, and 72 hours after surgery)
- Aspartate aminotransferase (AST)(Baseline, 24, 48, and 72 hours after surgery)
- Serum creatinine(Baseline, 24, 48, and 72 hours after surgery)
- Blood urea nitrogen(Baseline, 24, 48, and 72 hours after surgery)
- Plasma angiopoietin-2 concentration(Baseline, 24, 48, and 72 hours after surgery)
- Plasma double-stranded DNA (dsDNA) concentration(Baseline, 24, 48, and 72 hours after surgery)
- Plasma high-mobility group box 1 (HMGB1) concentration(Baseline, 24, 48, and 72 hours after surgery)
- Plasma neurofilament light chain (NFL) concentration(Baseline, 24, 48, and 72 hours after surgery)
- Plasma S100B concentration(Baseline, 24, 48, and 72 hours after surgery)