CTRI/2014/06/004665已完成3 期
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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Female or male patients of any ethnicity
- •2. 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)
- •3. MELD score >=7 and <=29
- •4. Patient is expected to require PN for a minimum of 4 and maximum of 7 consecutive days
- •5. Patient is expected to receive >=70 % of the individual energy demand by PN for a minimum of 4 days
- •6. Age between 18 and 65 years
- •7. BMI >=16 and <=35 kg/m2
- •8. Patient is capable to give Informed Consent
- •9. Informed Consent Form signed by the patient or an impartial witness.
排除标准
- •1. 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
- •2. Acute organ transplantations (liver, pancreas, small bowel, kidney)
- •3. 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)
- •4. Patient is expected to receive more than 30% of the individual energy demand by ON/EN during the first 4 days of treatment
- •5. Known or expected hypersensitivity to fish-, egg-, soybean-, olive or peanut protein or to any of the active substances or excipients
- •6. Severe renal impairment (creatinine clearance [CLCR] <30 ml/min)
- •7. INR >2.5
- •8. Severe liver insufficiency or total bilirubin 3-times higher than the upper limit of normal
- •9. Inborn error of amino acid metabolism
- •10. Present signs of acute pancreatitis as diagnosed by clinical features
- •11. High likelihood of severe and life-threatening complications related to initial measures in the attempt to control the underlying disease
- •12. Instable septic shock or any other highly vulnerable condition of the cardiovascular system, such as uncompensated cardiac insufficiency/congestive heart failure
- •13. Severe metabolic acidosis
- •14. Severe hyperlipidaemia
- •15. Hyperhydration or fluid overload and/or pulmonary oedema
- •16. Uncontrolled hyperglycaemia
- •17. Pathologically elevated serum levels of any of the included electrolytes
- •18. Haemophagocytic syndrome
- •19. Any serious or clinically significant condition that would preclude participation in the study (in the opinion of the investigator)
- •20. Patient is pregnant or lactating and intends to continue breast-feeding
- •21. Inadequate presentation or condition of the peripheral veins (dorsal hand, forearm, cubital veins)
- •22. 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
- •23. Skin alterations that could potentially interfere with adequate assessment of local skin reactions.
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