Intravenous Vitamin C for the Prevention of Postreperfusion Syndrome in Orthotopic Liver Transplantation From Deceased Donors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Postreperfusion syndrome
研究概览
简要总结
The goal of this clinical trial is to test the efficacy of intravenous ascorbic acid in preventing the postreperfusion syndrome in liver transplantation. The main questions it aims to answer are:
- Can intravenous ascorbic acid prevent postreperfusion syndrome in liver transplantation ?
- Can ascorbic acid decrease the incidence of liver graft dysfunction after liver transplantation?
- Can ascorbic acid decreased the incidence of postoperative complications after liver transplantation ?
Participants will receive 1.5 g of intravenous ascorbic acid diluted in 100 ml of saline or 100 ml of saline alone, during the anhepatic phase of liver transplantation before reperfusion of the new graft.
Researchers will compared the incidence of postreperfusion syndrome in both groups.
详细描述
Researches will compared:
- Incidence of postreperfusion syndrome in liver transplantation
- Changes in interleukin values and other inflammatory markers before and after transplantation
- Incidence of liver graft dysfunction between groups
- Incidence of acute renal failure and other complications between groups
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)
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing liver transplantation
排除标准
- •Pregnancy
- •Allergy to ascorbic acid
- •Nephrolithiasis
- •Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Hyperoxaluria
- •Hyperuricemia
- •Haemochromatosis
- •Sickle cell anemia
- •Serum Creatinine > 1.2 mg/dl in women and 1.3 mg/dl in men
- •Split liver graft
- •Acute liver failure
- •Living donor liver transplantation
- •Controlled donor asystolia
- •Treatment with: indinavir, Vitamin B12, Cyclosporine, iron, deferoxamine, disulfiram
研究组 & 干预措施
Ascorbic acid
1.5 gr of ascorbic acid diluted in 100 ml of 0.9% saline solution will be administered intravenously during the anhepatic phase of liver transplantation
干预措施: Ascorbic acid (Drug)
Saline solution
100 ml of 0.9% saline solution will be administered during the anhepatic phase of liver transplantation
干预措施: 0.9% Saline solution (Drug)
结局指标
主要结局
Postreperfusion syndrome
时间窗: Within the first 5 minutes after reperfusion of the grafted liver
When mean arterial pressure decreases by more than 30% relative to the value at the end of the anhepatic phase and lasts for at least 1 min
次要结局
- Ascorbic acid serum levels(Immediately before induction of anesthesia and 12 hours after repercussion of the graft)
- Interleukin1beta (IL-1β) levels(Immediately before induction of anesthesia and 12 hours after repercussion of the graft)
- Tumor Necrosis Factor-alpha (TNFα) levels(Immediately before induction of anesthesia and 12 hours after repercussion of the graft)
- Interleukin-6 levels (IL-6)(Immediately before induction of anesthesia and 12 hours after repercussion of the graft)
- Interleukin-8 (IL-8) levels(Immediately before induction of anesthesia and 12 hours after repercussion of the graft)
- Interferon gamma (IFNγ) levels(Immediately before induction of anesthesia and 12 hours after repercussion of the graft)
- Primary graft dysfunction(First postoperative week)
- Acute renal failure(First postoperative week)
- Mechanical ventilation(Postoperative until day 30)
- Mortality(Up to day 30)
- Length of hospitalization(Through study completion (30 days))
- Length of Intensive Care Unit (ICU) stay(Through study completion (30 days))
- Duration of vasopressor support after transplantation(Postoperative until study completion (30 days))
- Maximum dose of vasopressor support after transplantation(Postoperative until study completion (30 days))
研究者
Luis Gajate Martín
Principal investigator
Hospital Universitario Ramon y Cajal