Status:
COMPLETED
Efficacy and Safety of SmofKabiven Peripheral Versus Compounded Emulsion
Lead Sponsor:
Fresenius Kabi
Collaborating Sponsors:
Parexel
Conditions:
Parenteral Feeding
Surgery
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The present protocol describes a randomized, open-labelled study in which either SmofKabiven Peripheral or a hospital compounded control Parenteral Nutrition (PN) regimen will be given to adult surgic...
Detailed Description
In addition, other variables will be assessed in this study, i.e., C-reactive Protein (CRP), free fatty acids, immunology parameters, taurine, comparison of the time required for Total Parenteral Nutr...
Eligibility Criteria
Inclusion
- Patient is scheduled to undergo elective abdominal surgery
- Female or male patient, age between 18 and 75 years (inclusively)
- Postoperatively, patient is expected to receive 100% of the total daily energy demand via PN for at least 5 consecutive days
- Body Mass Index (BMI) ≥ 16 and ≤ 30 kg /m2, and actual body weight ≥ 40 kg
- Patient is capable to give Informed Consent, agrees to participate in the study, and signs the Informed Consent Form
Exclusion
- Patient has received PN or parenteral amino acids in the last 10 days before randomization (exception: administration of glucose will be allowed)
- Severe liver insufficiency or AST, ALT or total bilirubin at least 1.5-times higher than the upper limit of normal range
- International Normalised Ratio (INR) at least 1.5 times higher than the upper limit of normal range
- Uncontrolled hyperglycaemia, fasting blood glucose \> 180 mg/ dl (10 mmol/L)
- Severe renal impairment defined as serum creatinine value at least 1.5 times higher than the upper limit of normal range
- Serious hyperlipidaemia (serum cholesterol and/or triglycerides and/or LDL-C level at least 1.5 times higher than the upper limit of normal range)
- Inborn abnormality of amino acid metabolism
- Present signs of acute pancreatitis, hypothyroidism or hyper-thyroidism as diagnosed clinically
- Serum level of any of the electrolytes (sodium, potassium, magnesium, total calcium, chloride, phosphate) above the upper limit of the normal range
- Known unstable metabolism (e.g., known metabolic acidosis)
- Known hypersensitivity to fish-, egg-, soybean, or peanut protein or to any of the active substances or excipients of the study drugs
- General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency /congestive heart failure
- Unstable conditions (e.g., acute myocardial infarction, stroke, embolism, severe sepsis, shock)
- Drug abuse and/or chronic alcoholism
- Psychiatric diseases, epilepsy
- Administration of growth hormones within the previous 4 weeks before surgery, or chronic maintenance therapy with systemic glucocorticoids 4 weeks before surgery
- 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
- Development of intraoperative/ postoperative conditions (assessed after surgery and before enrollment of patients):
- Intra-operative blood loss \> 1000ml;
- Development of a condition in which PN is contraindicated;
- Intra- or postoperative urine output \<0.5 ml/kg/h;
- Need for postoperative haemo-filtration or dialysis;
- Contraindication or inability to obtain peripheral or central venous catheter access;
- Intra-operative decision on limited treatment, e.g. due to diagnosis of carcinomatosis;
- Intra-operative severe complications including resuscitation, hemorrhagic and septic shock, acute single and multiple organ dysfunction including pulmonary, hepatic, and renal dysfunction prohibiting early postsurgical extubation, requiring liver-specific treatment and renal replacement therapy.
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2018
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT03792087
Start Date
December 21 2017
End Date
December 30 2018
Last Update
August 2 2021
Active Locations (5)
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1
Beijing Friendship Hospital Capital Medical University
Beijing, China
2
Peking University People's Hospital
Beijing, China
3
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
4
The Affiliated Hospital of Qingdao University
Qingdao, China