Safety and local tolerance of SmofKabiven® Peripheral versus Kabiven® Peripheral: An assessor-blinded, randomised, controlled, multi-centre, non-inferiority study in adult patients with gastrointestinal disorders requiring parenteral nutrition
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 study will be a prospective, randomized, controlled, assessor blinded, multi-centre, non-inferiority clinical trial assessing the safety of the SmofKabiven® Peripheral versus Kabiven® Peripheral and also to assess the the local vein tolerance of the study drugs. The primary safety assessment will be the relative reduction of the individual Model of End Stage Liver Disease (MELD) score at the final visit versus baseline (Day -1).The MELD score is a combined surrogate marker for hepatic and renal function and the secondary end point includes clinical laboratory evaluation, reported adverse events, vital signs, physical examination, the total severity score (TSS) of local vein- and local skin reactions assessed from Day 1 to the last day of vein inspection 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
- Outcome Assessor Blinded
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 requires PN due to a gastrointestinal disorder or after elective major abdominal surgery (major abdominal surgery includes 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)
- •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
- •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)
- •Patient is expected to receive more than 30% of the individual energy demand by ON/EN during the first 4 days of treatment
- •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
- •Severe hyperlipidaemia
- •Hyperhydration or fluid overload and/or pulmonary oedema
- •Uncontrolled hyperglycaemia
- •Pathologically elevated serum levels of any of the included electrolytes
- •Haemophagocytic syndrome
- •Any serious or clinically significant condition that would preclude participation in the study (in the opinion of the investigator)
- •Patient is pregnant or lactating and intends to continue breast-feeding
- •Inadequate presentation or condition of the peripheral veins (dorsal hand, forearm, cubital veins)
- •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
- •Skin alterations that could potentially interfere with adequate assessment of local skin reactions.
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 (value at Screening).
时间窗: Final visit versus pre-surgery screening visit
The MELD score is a composite score combiningthe 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 including local vein and skin reactions(Severity,seriousness,clinical relevance,relatedness and outcome of AEs)