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临床试验/NCT00247793
NCT00247793已完成不适用

The Effect of Pre- and Postoperative Supplemental Enteral Nutrition in High-Risk Patients Undergoing Elective Cardiac Surgery. A Prospective Double Blind Study.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家开始时间: 1996年7月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
试验地点
2
主要终点
Postoperative infectious morbidity

研究概览

简要总结

Effect of two preoperative oral immune-enhancing nutritional supplements in patients at high risk of infection after cardiac surgery: a randomized placebo-controlled study.

Introduction: In our first study we showed that the use of a preoperative oral immune-enhancing nutritional supplement (OIENS) resulted in an improved patients' host-defence with a reduction in postoperative infectious morbidity in 'high-risk' cardiac surgery patients. The use of the OIENS resulted also in less postoperative organ dysfunction. Experimental studies have shown that additional glycine results in less ischemia-reperfusion damage and that glycine has anti-inflammatory properties.

Objective: The use of an OIENS in the preoperative period in patients at high risk of infection after elective cardiac surgery with the use of cardiopulmonary bypass (CPB) results in a reduction in infections as in our first study. The addition of 9.6 gram glycine per sachet OIENS results in a further reduction in postoperative dysfunction.

Design: A prospective randomized placebo controlled study with two oral immune enhancing nutritional formula's and an isocaloric control formula. Patients: Seventy-four consecutive patients undergoing cardiac surgery with the use of an CPB who met one or more of the following inclusion criteria: Age 70 years or older, mitral valve replacement or cardiac ejection fraction less then 40%. Exclusion criteria were age < 18 years, proven malignancy, use of corticosteroids, severe renal and liver failure. Definition of a protocol violation was the intake of less then 5 L or more then 10 L of the nutritional supplement in the preoperative period.

Intervention: Patients were split up in three groups by concealed randomisation. One group received the arginine, omega3-PUFAs and nucleotides enriched formula (OIENS). Another group received the OIENS further enriched with glycine (OIENS+glyc). The control group received an isocaloric nutritional supplement without the enrichments.

详细描述

Objective To study the effect of two preoperative immune enhancing nutritional supplements compared with a control nutritional supplement in 'high risk' risk cardiac surgery patients

Introduction: Elderly patients and patients with a poor ventricular function undergoing cardiac operations with hypothermic cardiopulmonary bypass (CPB), have an increased postoperative morbidity and mortality. Host defence may be diminished due to nutritional deficiencies, hypoperfusion, anaesthesia and operative trauma. Immune function is additionally depressed by the use of CPB and hypothermia. It has been suggested that L-arginine can improve postoperative outcome in cardiac surgery patients, glycine may have a role in protecting tissues against insults such as ischemia-reperfusion and hypoxia, and omega-3 polyunsaturated fatty acids (omega3-PUFA's) can limit the postoperative generalised inflammatory response.

Experimental studies have shown that the use of nutritional supplements containing L-arginine, omega3-PUFA's or nucleotides, boost immune responsiveness after surgery or trauma. L-arginine is a semi-essential amino acid and precursor of nitrous oxide (NO), the most important endothelial vasodilator. In experimental studies, L-arginine improved wound healing, restored postoperative depressed macrophage function and lymphocyte responsiveness and augmented resistance to infections. Arginine protected against ischemia-reperfusion injury by increasing oxygen delivery upon reflow, thereby improving cardiac function. The intake of additional omega3-PUFA's alters cell membrane phospholipid content and prostaglandin synthesis. This might be an important factor in limiting the generalised inflammatory response and subsequent immunosuppression and capillary leakage following major surgery. Purines and pyrimidines are essential nutrients for rapidly dividing cells. The administration of nucleotides in the form of yeast-RNA has improved the host immune response to an infectious challenge. In experimental studies glycine has been proven cytoprotective in stomach, kidney, liver and cardiovascular system. The metabolic response to oral glycine is that it facilitates the uptake op glucose from the circulation.

The immunonutrients, arginine, omega3-PUFA's and yeast-RNA, have been combined into a single oral immune enhancing nutritional supplement (OIENS). In cancer surgery, trauma and critically ill patients 'post event' nutrition with this immune enhancing formula has improved immunocompetence, reduced infections and shortened length of stay in the hospital (LOSH). The onset of the effect of postoperative immune enhancing nutrition starts after 3 days and seems to be dose dependent. For this reason, it can be hypothesised that it may be beneficial to commence an oral immune enhancing nutritional supplement (OIENS) before surgery. A recent published clinical trail showed that the OIENS with these three immunonutrients in high risk cardiac surgery patients improves preoperative clinical relevant immunological parameters, reduced postoperative infectious morbidity and attenuated postoperative organ dysfunction. Recently, the three immunonutrients have been combined with glycine into a new single OIENS. Aim of the present study in 'high risk' cardiac surgery patients was to determine whether the intake of the new OIENS for minimally five days improves preoperative host defence and subsequently reduces postoperative infections and organ dysfunction.

Study design: A prospective randomized placebo-controlled three armed double blind study

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing cardiac surgery with the use of cardiopulmonary bypass, who met one of the following criteria
  • age >= 70 years
  • poor left ventricular function (ejection fraction < 0.4)
  • mitral valve replacement

排除标准

  • Age =< 21 years
  • Pregnancy
  • Insulin dependent diabetes mellitus
  • Hepatic Cirrhosis
  • Known malignancy
  • Use of chemotherapy, NSAIDs (except ASA), or corticosteroids
  • Schizophrenia
  • Severe renal failure (creatinine clearance < 25 mL/h) before study entrance
  • Patients with an organ transplantation in the past

结局指标

主要结局

Postoperative infectious morbidity

Mortality

次要结局

  • Immunological measurements
  • Postoperative organ function/support
  • Recovery (Length of ICU stay, postoperative length of hospital stay)

研究者

研究点 (2)

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