Safety and Tolerance of SmofKabiven@versus Kabiven@:AnOpen, Randomized, Controlled, Multi-Centre, Non-Inferiority Study in AdultPatients Requiring Parenteral Nutrition after Major Abdominal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 8
- 主要终点
- Primary variable:
研究概览
简要总结
This is a prospective, randomized, controlled, open, multicentre, non-inferiority clinical trial assessing the Safety and tolerance of SmofKabiven® versus Kabiven. The primary safety assessment is the relative reduction of the individual Model of End Stage Liver Disease (MELD) score at the final visit versus baseline (Day -1) and the secondary end point includes clinical laboratory evaluation, reported adverse events, vital signs, physical examination and number of days on PN for each of the study drugs
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Female or male patients of any ethnicity
- •Patient is scheduled to undergo elective major abdominal surgery including surgery for cancer and non-cancer reasons including distant metastases with completely and incompletely resectable tumors: e.g., surgery for bleeding duodenal ulcer, gastrectomy, resection of small bowel, appendectomy, splenectomy, colectomy, vascular surgery, hysterectomy, ovarectomy
- •Patient has or is scheduled to peri-operatively receive a central venous catheter for routine medical care purposes
- •MELD score ≥7 and ≤29
- •Patient is expected to require PN for a minimum of 4 and maximum of 7 consecutive days
- •Patient is expected to receive ≥70 % of the individual energy demand by PN for a minimum of 4 days
- •Age between 18 and 65 years
- •BMI ≥16 and ≤35 kg/m2
- •Patient is capable to give Informed Consent
- •Informed Consent form signed by the patient or an impartial witness.
排除标准
- •Elective surgeries possible interfering with the parameters important in calculating the primary outcome measure: excessive hepatectomy with less than 50% of viable tissue remaining, cholecystectomy, nephrectomy
- •Patient is expected to receive more than 30% of the individual energy demand by ON/EN during the first 4 days of treatment
- •Acute organ transplantations (liver, pancreas, small bowel, kidney)
- •Patient has received PN (lipids and/ or amino acids with glucose) in the last 10 days prior to screening (the sole administration of glucose will be allowed)
- •Known or expected hypersensitivity to fish-, egg-, soybean-, olive or peanut protein or to any of the active substances or excipients
- •Severe renal impairment (creatinine clearance [CLCR] <30 ml/min)
- •Severe liver insufficiency or total bilirubin 3-times higher than the upper limit of normal
- •Inborn error of amino acid metabolism
- •Present signs of acute pancreatitis as diagnosed by clinical features
- •High likelihood of severe and life-threatening complications related to initial measures in the attempt to control the underlying disease
- •Instable septic shock or any other highly vulnerable condition of the cardiovascular system, such as uncompensated cardiac insufficiency/congestive heart failure
- •Severe metabolic acidosis
- •Hyperhydration or fluid overload and/or pulmonary oedema
- •Uncontrolled hyperglycaemia
- •Severe hyperlipidaemia
- •Pathologically elevated serum levels of any of the included electrolytes
- •Haemophagocytic syndrome
- •Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during study
- •Patient is pregnant or lactating and intends to continue breast-feeding.
结局指标
主要结局
Primary variable:
时间窗: Final visit versus pre-surgery screening visit
The primary safety parameter will be the relative reduction of the individual Model of End Stage Liver Disease (MELD) score at the final visit versus baseline (pre-surgery, screening visit).The MELD score is a composite score combining the officially acknowledged surrogate markers for hepatic and renal function (bilirubin, INR and creatinine, respectively).
时间窗: Final visit versus pre-surgery screening visit
•Outcome: safety
时间窗: Final visit versus pre-surgery screening visit
•Metric: Model of End Stage Liver Disease (MELD) score
时间窗: Final visit versus pre-surgery screening visit
次要结局
- Individual total number of adverse events (AEs)(Severity, seriousness, clinical relevance, relatedness and outcome of AEs)