Effect of Preoperative Oral Carbohydrate Loading on Postoperative Outcomes in Liver Transplant Patients: A Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- Hospital-Free Days at 30 (HFD30)
研究概览
简要总结
The aim of the study is to evaluate the effect of preoperative oral carbohydrate loading on postoperative outcomes in liver transplant recipients. The results of this study may contribute to improving recovery after liver transplantation and shortening postoperative hospital stay in these patients.
Participants will be randomly assigned to either the study group or the control group. Patients assigned to the study group will receive 400 mL of a carbohydrate beverage (Nutricia preOp®), to be consumed up to 2 hours before the anesthesia induction. Patients assigned to the control group will receive 400 mL of a placebo administered in an identical manner as in the study group. Participants will not be informed which group they have been assigned to.
In the postoperative period, routine laboratory and imaging tests will be performed, and their results will be used to assess the effects of the intervention. Follow-up of the patient's clinical course is planned for up to 30 days after surgery. The schedule of follow-up visits will not differ from standard clinical practice.
详细描述
The aim of the study is to evaluate the effect of preoperative oral carbohydrate loading on postoperative recovery in liver transplant recipients. Additionally, the study aims to assess the effect of preoperative oral carbohydrate loading on additional recovery parameters following liver transplantation, such as length of stay in the intensive care unit, time to first oral intake, and time to recovery of gastrointestinal function.
Participants will be randomly assigned in a 1:1 ratio to the study group or control group using block randomization with a block size of 10. A randomization list of 440 allocations will be generated prior to enrolment. Recruitment will end after the planned sample size of 434 participants is achieved and remaining allocations will not be used. Patients assigned to the study group will receive 400 mL of a carbohydrate beverage (Nutricia preOp®), to be consumed up to 2 hours before the anesthesia induction. Patients assigned to the control group will receive 400 mL of a placebo administered in an identical manner as in the study group. Participants will not be informed which group they have been assigned to.
In the postoperative period, routine laboratory and imaging tests will be performed, and their results will be used to assess the effects of the intervention. Follow-up of the patient's clinical course is planned for up to 30 days after surgery. The schedule of follow-up visits will not differ from standard clinical practice. No biological material will be collected or stored for the purposes of this study.
Hospital-Free Days at 30 (HFD30), defined as the number of days a patient is both alive and discharged from the hospital within the first 30 days after transplantation, will serve as the primary endpoint, reflecting early postoperative recovery. Based on retrospective data, the mean number of HFD30 was 9.4, with a standard deviation (SD) of 7.1. To detect a 2-day difference with 80% power and a two-sided alpha of 0.05, assuming a 10% early postoperative loss, a total of 434 patients (217 per group) will be required.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •elective liver transplantation at the Department of General, Transplant, and Liver Surgery, Medical University of Warsaw
- •grafts from brain-dead donors
- •MELD score <35
排除标准
- •acute liver failure
- •insulin-dependent diabetes mellitus
- •gastroparesis
- •mechanical bowel obstruction
- •liver retransplantation within less than 6 months of the primary transplant
研究组 & 干预措施
Preoperative Oral Carbohydrate Loading Group
Participants will receive 400 mL of a preoperative oral carbohydrate drink (Nutricia preOp®), with intake completed 2 hours prior to anesthesia induction.
干预措施: Preoperative Oral Carbohydrate Loading (Dietary Supplement)
Placebo Group
Participants will receive 400 mL of a water-based, sensory-similar placebo drink, with intake completed 2 hours prior to anesthesia induction. The placebo contains a low concentration of sugar for flavoring to mimic the taste of the carbohydrate drink.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Hospital-Free Days at 30 (HFD30)
时间窗: From the date of liver transplantation up to 30 days post-surgery
The number of days a patient is both alive and discharged from the hospital within the first 30 days after transplantation.
次要结局
- Time to First Oral Intake(From the end of surgery up to hospital discharge, assessed up to 30 days)
- Time to Return of Gastrointestinal Function(From the end of surgery up to hospital discharge, assessed up to 30 days)
- Incidence of Postoperative Infections(From the date of liver transplantation up to 30 days post-surgery)
- Length of ICU Stay(From the date of ICU admission until transfer to a surgical ward or hospital discharge (up to 30 days))
- Incidence and Severity of Postoperative Complications(From the date of liver transplantation up to 30 days post-surgery)