To Compare the Outcome of Temporary Portocaval Shunt During Recipient Hepatectomy Versus No Shunt in Adult Elective Live Donor Liver Transplantation- A Prospective Randomised Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Ionotropes requirement between two groups at fixed time points
研究概览
简要总结
Temporary portocaval Shunt during recipient hepatectomy improves intra operative parameters and morbidity in LDLT recipients
详细描述
All patients satisfying the inclusion criteria, written informed consent will be taken and patients are randomized into intervention group ( Portocaval Shunt Group) and Non intervention group ( No Shunt Group).Patients from both the groups will be assessed for Hemodynamic parameters, Urine Output, Blood loss, blood products requirement , Duration of surgery during the procedure. They will be assessed for renal function, presence of sepsis, Morbidity, early graft dysfunction, ICU stay and total hospital stay in the post operative period.All patients will be followed up till discharge from hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Adult LDLT Recipients at ILBS, New Delhi
排除标准
- •Acute Liver Failure as an indication for transplant
- •Pediatric transplants
- •Presence of Yerdel grade III and grade IV Portal vein thrombosis
- •Presence of significant portosystemic shunting (greater than 10mm) in pre operative period.
- •Patients who have undergone TIPS procedure.
- •Hypercoagulable states like Budd-Chiari syndrome
- •Refusal to participate in the study
结局指标
主要结局
Ionotropes requirement between two groups at fixed time points
时间窗: T4- During procedure- Before closure of abdomen
Noradrenaline and Vasopressin requirement in milliliter/hour
Blood Pressure between two groups at fixed time points
时间窗: T4- During procedure- Before closure of abdomen
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg
Lactate level between two groups at fixed time points
时间窗: T4- During procedure- Before closure of abdomen
Lactate levels are documented from Arterial Blood Gas analysis
Blood loss between two groups during intraoperative period
时间窗: During Procedure
Blood loss during the procedure is measured in milliliter
Duration of surgery between two groups.
时间窗: During Procedure
Duration between incision time to closure of abdomen is noted in minutes
Increase in creatinine levels of Increase 1.5-1.9 times from baseline in the post op period.
时间窗: Number of days post transplantation procedure (upto 45 days)
Serum Creatinine is measured in milligram per deciliter
≥0.3 mg/dl increase within 48 h or Urine output < 0.5 ml/kg/h for 6-12 h in the post op period.
时间窗: Number of days post transplantation procedure (upto 45 days)
Serum Creatinine is measured in milligram per deciliter
Urine output between two groups
时间窗: During Transplantation procedure
Urine output during the transplantation procedure is measured in milliliter
次要结局
- Number of days of hospital stay(Number of days post transplantation procedure (upto 45 days))
- Incidence of Morbidity(Number of days post transplantation procedure (upto 45 days))
- Endotoxin levels(Levels of Serum endotoxin levels in pre op and 12 hours after surgery)
- Incidence of sepsis(Number of days post transplantation procedure (upto 45 days))
- Number of days of ICU stay(Number of days post transplantation procedure (upto 45 days))
- Number of patients with Early allograft dysfunction(For 5 consecutive days after day 7)
- To compare tolerance to enteral feed between two groups(Number of days post transplantation procedure (upto 45 days))