Intraoperative Hemodynamic Management and Postoperative Outcomes in Liver Transplantation: a Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 852
- 试验地点
- 1
- 主要终点
- Occurence of primary graft dysfunction
研究概览
简要总结
The overarching objective of the research program entitled ELIPTO (Enhancing Liver Insufficiency and Postoperative Transplantation Outcomes) (www.elipto.ca) is to improve the perioperative care of liver transplant recipients. One of this program's purposes is to better define the effects of intraoperative hemodynamic management on postoperative outcomes in adult liver transplant recipients. In this study, the incidence of postoperative complications within this population will be defined in Canada and France and the association between intraoperative hemodynamics and postoperative outcomes will be measured.
Liver transplantation improves the survival of patients with end-stage liver disease (ESLD). It is the second most transplanted organ with a continuously increasing annual number of transplantations, an observation partly explained by an endemic ESLD etiology in the United States, the obesity-related non-alcoholic steatohepatitis (NASH) cirrhosis. In recent decades, although sicker patients are prioritized, survival has improved possibly through an overall improvement in the quality of care. However, postoperative complications have concomitantly increased. On average, liver transplant recipients suffer from more than three postoperative complications, mainly infectious, pulmonary, renal or graft-related, two thirds of them being severe. In a low-risk patients cohort, close to 60% of all patients suffered from at least one severe complication up to 6 months after surgery. Such complications increase mortality, readmissions and cost of care. Organs available for transplantation are a scarce resource; up to 10% of grafts are no longer functional after one year. Interventions that improve patients' postoperative and graft outcomes are needed and few perioperative ones are supported by high-quality evidence.
详细描述
OBJECTIVES:
The main objective of this study is to describe and measure the effects of intraoperative hemodynamic management on postoperative outcomes in liver transplantation in Canada and France.
The specific objectives are:
- To describe the overall incidence of postoperative complications and graft outcomes in adult liver transplant recipients in Canada and France and across different recipients' characteristics.
- To measure the effects of fluid balance, within an overall hemodynamic instability and management strategy, on the postoperative outcomes of liver transplant recipients in Canada and France.
The central hypotheses of this study are that an intraoperative hemodynamic management based on a restrictive fluid administration may improve postoperative outcomes in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive adult liver transplant recipients in each center during a one-year period or more (anywhere in between June 1, 2021 and November 30, 2022).
排除标准
- •Same patients who undergo a retransplantation during the same period of observation.
结局指标
主要结局
Occurence of primary graft dysfunction
时间窗: At 7 days after transplantation
This outcome was chosen because preliminary data from the CHUM suggested that a higher fluid balance was associated with primary graft non-function (retransplantation or death). Since graft perfusion is correlated with cardiac output, intraoperative hemodynamic management may have an effect on graft perfusion and postoperative graft function. Also, this is a well-defined, quantitative definition, that is associated with overall graft and patient survival. Since graft loss of 10% at 1 year is a concern among the transplant community, finding causes and solutions to improve graft function is paramount.
次要结局
- Occurrence of biliary complications(Up to 6 months after transplantation)
- Hospital length of stay(30 days after transplantation)
- Retransplantation(Up to 6 months after transplantation)
- The need for a new postoperative ICU admission(Up to 30 days after transplantation)
- 30-day organ dysfunction free days(Up to 30 days after transplantation)
- Liver transplant-related reoperations(Up to 30 days after transplantation)
- Occurence of acute rejection episode(30 days after transplantation)
- Survival up to 6 months(6 months after transplantation)
- Occurence of biliary anastomotic strictures(Up to 6 months after transplantation)
- Occurence of acute kidney injury(48 hours, 7 days and 30 days after transplantation)
- Occurence of infectious complications(Up to 30 days after transplantation)
- 30-day mechanical ventilation free-days(Up to 30 days after transplantation)
- Occurrence of pulmonary complications(Up to 30 days after transplantation)
