Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Alanine aminotransferase (ALT)
研究概览
简要总结
Our primary aim is to investigate whether perioperative remote ischemic conditioning (PRIC) as an adjunctive treatment can improve postoperative recovery in patients undergoing hepatectomy as an adjunct to standard treatment.
详细描述
Remote Ischemic Conditioning (RIC) can be applied as repeated short-lasting ischemia in a distant tissue that results in protection against subsequent long-lasting ischemic injury in the target organ. This protection can be applied prior to or during a prolonged ischemic event as remote ischemic pre-conditioning (RIPreC) and per-conditioning (RIPerC), respectively, or immediate after reperfusion as remote ischemic post-conditioning (RIPostC).
RIC is a non-pharmacologic and non-invasive treatment without noticeable discomfort, commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion. However, whether perioperative remote ischemic conditioning (PRIC) can improve postoperative recovery in patients undergoing hepatectomy has never been investigated in a randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing hepatectomy under general anesthesia
- •American Society of Anesthesiology (ASA) grade of II ~ III
- •Male and female patients, age 25 to 75 years
- •New York Heart Association (NYHA) grade of I ~ III
排除标准
- •Patients with limb deformity or peripheral vascular disease affecting upper limb function
- •Patients with a medical history of nervous system, immune system and mental illness
- •Patients who have received hepatectomy in the past, have important organ diseases or have undergone surgical treatment recently
- •Patients who have recently used anti-inflammatory analgesics, anticoagulants, hormone drugs, immunosuppressants, and ATP-sensitive K-channel blockers (KATP)
- •Preoperative severe renal insufficiency (serum creatinine > 442 umol/L, with or without serum potassium > 6.5 mmol/L, or the clinician-recognized need for renal replacement therapy), liver insufficiency (Child-Pugh grade C)
- •Patients and/or their family members refuse to participate in the program
结局指标
主要结局
Alanine aminotransferase (ALT)
时间窗: 7 days
The levels of ALT in perioperative period
次要结局
- Rate of postoperative complications(30 days)
- Total bilirubin (TBIL)(7 days)
- Nuclear Factor-κB (NF-κB)(7 days)
- Platelet(7 days)
- White blood cell (WBC)(7 days)
- Aspartate aminotransferase (AST)(7 days)
- Malondialdehyde (MDA)(7 days)
- Heme oxygenase-1 (HO-1)(7 days)
- High mobility group box1 (HMGB1)(7 days)
- Neutrophil granulocyte percentage(7 days)
- Tumor necrosis factor-α (TNF-α)(7 days)
- International normalized ratio (INR)(7 days)
- Albumin (ALB)(7 days)
- Time to gastrointestinal tolerance(7 days)
- Prolonged postoperative ileus(7 days)