Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery: The ERIC-LIVER Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- serum AST (unit/L) following liver resection, measured at 24 hours
研究概览
简要总结
Liver resection has improved health outcomes in patients with hepatocellular carcinoma (HCC) in Singapore and worldwide. However, due to acute ischaemia/reperfusion injury (IRI) to the liver at the time of surgery, patients still experience significant morbidity and mortality. Therefore, novel therapies are required to protect the liver against acute IRI during partial hepatectomy. Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion has been shown to protect the liver in experimental animal studies. In the ERIC-LIVER trial the investigators investigate whether RIC can reduce liver injury and preserve liver function in patients with HCC undergoing partial hepatectomy.
详细描述
Liver resection has improved health outcomes in patients with hepatocellular carcinoma (HCC) in Singapore and worldwide. However, due to acute ischaemia/reperfusion injury (IRI) to the liver at the time of surgery, patients still experience significant morbidity and mortality. Therefore, novel therapies are required to protect the liver against acute IRI during partial hepatectomy. Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion has been shown to protect the liver in experimental animal studies. In the ERIC-LIVER trial the investigators investigate whether RIC can reduce liver injury and preserve liver function in patients with HCC undergoing partial hepatectomy.
50 patients with HCC undergoing partial hepatectomy will be randomised to receive either RIC (four-5 minute arm cuff inflations/deflations) or sham control (four-5 minute arm cuff simulated inflations/deflations) after induction of anesthesia and prior to surgical incision. The primary endpoint of the study will be acute liver injury assessed by serum transaminases measured at 24 hours post-resection. Secondary endpoints will include liver function in subset of patients (N=24, assessed by indocyanine green [ICG] clearance measured at 24 hours post-resection), incid ence of liver failure, episodes of confirmed sepsis, acute kidney injury, intensive care unit and hospital stay, and quality of life.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 21 years and above
- •Patients undergoing partial hepatectomy for primary HC
排除标准
- •Patients with significant pulmonary disease (FEV1<40% predicted).
- •Patients with known severe renal failure with a GFR<30 mL/min/1.73 m
- •Patients on sulphonylurea or nicorandil, as these medications may interfere with the protective effect of RIC.
- •Patients recruited into another study which may impact on this study. Significant peripheral arterial disease affecting the upper limbs.
- •Patients undergoing repeat liver resection surgery.
研究组 & 干预措施
Active RIC
Active RIC using a manual BP cuff to inflate to 200mmHg.
干预措施: Active RIC (Device)
Sham Control
A sham control using a manual blood pressure cuff visually identical to that used in the RIC protocol will be placed on the upper arm and a simulated RIC protocol will be administered.
干预措施: Sham Control (Device)
结局指标
主要结局
serum AST (unit/L) following liver resection, measured at 24 hours
时间窗: 24 hours
serum AST as a measure of acute liver injury
serum ALT (unit/L) following liver resection, measured at 24 hours
时间窗: 24 hours
serum ALT as a measure of acute liver injury
次要结局
- serum AST (unit/L) following liver resection, measured at 6 hours(6 hours)
- serum AST (unit/L) following liver resection, measured at 48 hours(48 hours)
- Rate of hospital admission(30 days)
- serum ALT (unit/L) following liver resection, measured at 48 hours(48 hours)
- Acute liver ischemia reperfusion injury on histology(up to 2 weeks)
- serum ALT (unit/L) following liver resection, measured at 6 hours(6 hours)
- Mortality(30 days)
- Episodes of culture-confirmed sepsis(30 days)
- Serum creatine (umol/L)(3 days)
- ITU and hospital stay(Up to 30 days)
- Indocyanine Green (ICG) retention test.(baseline in pre-admission clinic and post-operation day 1.)
- presence/absence of liver failure based on serum bilirubin and INR on post op day 5(Baseline and day 5 post-surgery)
- serum ALT (unit/L) following liver resection, measured at 2 weeks(2 weeks)