The Impact of Preoperative Oral Glutamine Intake on the Immunocompetence and Outcomes of Malnourished Patients Undergoing Major Abdominal Surgery Due to Malignancies - A Randomized, Placebo-controlled Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Morbidity
研究概览
简要总结
Malnutrition occurs in up to 50% of patients requiring elective surgery for neoplastic diseases. It exerts a detrimental influence on outcome of surgery, because it can suppress immune function, exaggerate stress response and cause organ system dysfunction. Increased susceptibility to infection, protracted wound healing, impaired blood clotting and vessel wall fragility have been shown to be the leading causes of postoperative morbidity and mortality in malnourished patients undergoing major surgical resections.
This trial is designed as a prospective randomized, double-blinded, placebo-controlled pilot study in a academic single center in Switzerland. A total of 50 malnourished patients with gastro-intestinal tumors will receive orally glutamine or placebo-treatment during a period of 5 days prior to surgery. The investigators hypothesize that oral Glutamine administration is feasible, well tolerated, will decrease postoperative morbidity, will suppress postoperative cell damage and inflammatory response, and will improve the perioperative immunocompetence of the patients.
详细描述
Background
Malnutrition occurs in up to 50% of patients requiring elective surgery for neoplastic diseases. It exerts a detrimental influence on outcome of surgery, because it can suppress immune function, exaggerate stress response and cause organ system dysfunction. Increased susceptibility to infection, protracted wound healing, impaired blood clotting and vessel wall fragility have been shown to be the leading causes of postoperative morbidity and mortality in malnourished patients undergoing major surgical resections.
Immuno- or pharmaconutrition, defined as enteral or parenteral nutritional therapy based on a variety of products, such as omega-3-fatty acids, glutamine, arginine, sulfur-containing amino acids, nucleotides and anti-oxidants, is thought to have beneficial effects on postoperative recovery in a wide variety of surgical patients. Studies have shown its clinical effectiveness in terms of reduced postoperative complications, shortening the hospital stay and reduced hospitalization costs. Torosian et al. showed that severely malnourished patients benefit from preoperative nutrition, which reduce postoperative complications by 20%.
Although there is clinical evidence for the administration of immunonutrition to patients in the perioperative period, our understanding of the optimal type and time of immunonutrition, the characteristics of patients that benefit most, as well as the immunological mechanisms responsible for its beneficial effect is limited.
Objective
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
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed and surgically resectable carcinomas
- •Candidates for elective surgery with an estimated surgical stress score
- •A Nutritional Risk Screening 2002 (NRS-200232) score ≥3
- •Age ≥ 18 years
- •Completed primary immunization with tetanus toxoid
- •Last tetanus booster ≥10 years back
- •Informed consent
- •Exclusion Criteria
- •Refusal to participate
- •Clinically relevant alterations of the pulmonary renal of hepatic function
- •Insulin-dependent diabetes mellitus
- •Pre-existing autoimmune diseases and immune-deficiencies
- •Neutropenia
- •Pregnancy
- •Age <18 years
- •Last tetanus booster <10 years back
- •Ongoing infection
- •Intestinal obstruction at the time of entry into the study
排除标准
- 未提供
研究组 & 干预措施
Glutamin
干预措施: Glutamine (Dietary Supplement)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Morbidity
时间窗: 6 weeks
次要结局
- Postoperative cell damage(Up to seven days after surgery)
- Inflammatory response(Up to seven days after surgery)
- Nutritional status(Up to seven days after surgery)
- Perioperative immunocompetence(Seven and one day(s) before surgery. Postoperative week 1 and 6.)