Randomized Controlled Double Blind Multi-Center Clinical Trial to Assess the Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- improved patients' nutritional and physiological status, fatigue score, as well as patients' health related quality of life.
研究概览
简要总结
Patients with endstage liver disease characteristically are malnourished which is associated with poor outcome. Formulas enriched with arginine,ω3 fatty acids, and nucleotides potentially improve their nutritional status. This randomized placebo-controlled double blind multicenter clinical trial with longterm preoperative supplementation with such an enriched formula will evaluate evaluate effects of such formulas on patients' quality of life, survival, and posttransplant morbidities.
详细描述
Background. Patients with end stage liver disease characteristically are malnourished which is associated with poor outcome. Formulas enriched with arginine, ω-3 fatty acids, and nucleotides, "immunonutrients", potentially improve their nutritional status. This study is designed to evaluate the clinical outcome of long-term "immunonutrition" of patients with end-stage liver disease while on the waiting list for liver transplantation.
Methods / design. A randomized controlled double blind multi-center clinical trial with two parallel groups comprising a total of 142 newly registered patients for primary liver transplantation has been designed to assess the safety and efficacy of the long-term administration of ORAL IMPACT®, an "immunonutrient" formula, while waiting for a graft. Patients will be enrolled the day of registration on the waiting list for liver transplantation. Study ends on the day of transplantation. Primary endpoints include patients' nutritional and physiological status, as measured by mid-arm muscle area, triceps skin fold thickness, grip strength, and fatigue score, as well as patients' health related quality of life. Furthermore, patients will be followed for 12 postoperative weeks to evaluate anabolic recovery after transplantation as shown by reduced post-transplant mechanical ventilation, hospital stay, wound healing, infectious morbidities (pneumonia, intra-abdominal abscess, sepsis, line sepsis, wound infection, and urinary tract infection), acute and chronic rejection, and mortality.
Discussion. Formulas enriched with arginine, ω-3 fatty acids, and nucleotides have been proven to be beneficial in reducing postoperative infectious complications and length of hospital stay among the patients undergoing elective gastrointestinal surgery. Possible mechanisms include downregulation of the inflammatory responses to surgery and immune modulation rather than a sole nutritional effect.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 18 and 68 years of age
- •Scheduled for first liver transplantation
- •Written informed consent
- •Protein-calorie malnutrition: Mid-arm muscle area (MAMA) <85% standard
排除标准
- •Patients < 18 and > 68 years
- •Pregnant or nursing women
- •History of hypersensitivity to arginine, ω-3 fatty acids, or nucleotides
- •Inability to take oral nutrition
- •Patients with fulminant or subacute hepatic failure requiring urgent transplantation
- •Mental condition rendering the subject incapable to understand the nature, scope, and consequences of the trial
- •Simultaneous participation in another clinical trial
结局指标
主要结局
improved patients' nutritional and physiological status, fatigue score, as well as patients' health related quality of life.
时间窗: while in the waiting list for liver transplantation
次要结局
- enhanced anabolic recovery after transplantation as shown by reduced post-transplant morbidities and mortalities(the first 12 posttransplant weeks)