Sepsis, Endothelial Function, and Lipids in Critically Ill Patients With Liver Failure (SELLIFA). Randomized Controlled Trial Comparing the Tolerance on Lipids and Safety of Isocaloric Parenteral Nutrition With Enteral Nutrition.
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Liver Failure
- 发起方
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in plasma concentration of triglycerides, total cholesterol, HDL-cholesterol, free fatty acids, apolipoproteins, lipoprotein (a)
- 状态
- 已完成
- 最后更新
- 16年前
概览
简要总结
The purpose of the study is to determine the tolerance on lipid metabolism and the safety of short-term parenteral nutrition as compared to enteral nutrition in critically ill patients with liver failure.
详细描述
An impaired lipid metabolism is often found in patients with liver disease and is assumed to influence the prognosis. The central role of lipid metabolism in the pathophysiology of fatty liver disease and steatohepatitis is well established. In cirrhotic patients, serum lipid levels are mostly decreased and related to the severity of liver failure; in addition, the structure and composition of lipoproteins differ from that of healthy individuals. A reduction in high-density lipoproteins has been associated with higher cytokines levels and a poorer clinical outcome in septic patients. Furthermore, the oxidative stress induced by septic complications in critically ill patients with liver failure may lead to further hepatocellular injury and activation of systemic inflammation cascade. In this setting, the influence of nutrition on lipid metabolism may have an impact on the severity of liver failure and associated complications. Although plasma clearance and oxidation of lipids were considered to be normal in the majority of patients with cirrhosis, most previous studies only reported the effects of an oral ingestion or parenteral infusion of lipids during a few hours. The present randomized controlled trial will be conducted in a subgroup of patients enrolled in the SELLIFA-01 prospective study (NCT00488917). The purpose of the nutritional trial is to determine the tolerance on lipid metabolism and the safety of isocaloric short-term parenteral nutrition as compared to enteral nutrition in critically ill septic and non septic patients with liver failure. The nutrition will be delivered continuously for 5 days and will provide a daily energy supply corresponding to current resting energy expenditure as determined by indirect calorimetry, with 35% of total energy requirements as lipids, 15% as proteins (maximum 1.2g/kg ideal body weight/day), and 50% as dextrose. A tight glucose control strategy will be implemented to avoid hyperglycemia. The trial is designed to randomly assign 15 patients in each interventional group in order to detect more than 25% increase in plasma triglycerides levels with 80% statistical power for two-tailed type I error of 5%.
研究者
入排标准
入选标准
- •All consecutive patients with a diagnosis of chronic liver failure;
- •Planned total nutritional support;
- •Adult patient aged 18 years or above, and less than 85;
- •Admission to the ICU for an expected period of \> 24 hours;
- •Informed consent of the patient or nearest relative.
排除标准
- •Absolute contra-indications to enteral nutrition : total mechanical ileus, persistent vomiting, high output fistulas, uncertain gastrointestinal anastomosis;
- •Absolute contra-indications to parenteral nutrition : severe hypertriglyceridemia \> 6 mmol/l (\> 545 mg/dL), severe diabetic ketoacidosis;
- •Age less than 18 years or more than 85;
- •Pregnancy, including HELLP syndrome;
- •Active malignancy with metastases (localized hepatocellular carcinoma is not an exclusion criteria);
- •Systemic chemotherapy in the last 4 weeks (trans-arterial chemo-embolisation for localized hepatocellular carcinoma is not an exclusion criteria);
- •Acquired immunodeficiency syndrome and antiretroviral therapy;
- •Refusal of the patient or nearest relative.
结局指标
主要结局
Change in plasma concentration of triglycerides, total cholesterol, HDL-cholesterol, free fatty acids, apolipoproteins, lipoprotein (a)
时间窗: within 5 days
次要结局
- Incidence of hyperglycaemia(within 5 days)
- Alteration of liver function(within 5 and 28 days)
- Gastrointestinal intolerance(within 5 days)
- Gastrointestinal bleeding(within 5 and 28 days)
- Septic complications(within 5 and 28 days)
- Occurence of new organ dysfunction(within 5 and 28 days)
- Length of stay in the intensive care unit (ICU)(within 5 and 28 days)
- Mortality(within 5 and 28 days)