A Safety, Efficacy Study of CombiflexOmega Peri Versus SmofKabiven Peripheral in Patients With Parenteral Nutrition

Phase 3

Completed

• Conditions: Parent
• Interventions: Drug: CombiflexOmega peri; Drug: SmofKabiven peripheral

• Registration Number: NCT01533298
• Lead Sponsor: JW Life Science

Brief Summary

The purpose of this study is to compare the safety and efficacy of CombiflexOmega peri in comparison to SmofKabiven peripheral in postoperative patients requiring parenteral nutrition.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-15
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-15
• Last Update Posted: 2013-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients aged 20 and older
• Patients are expected to require PN for more than 3 days
• Patients who voluntarily signed the consent form

Exclusion Criteria

• Patients are expected difficult to survive more than 3 days

• Pregnant or breast-feeding women

• BMI > 30 kg/m2

• Patients with severe blood coagulation disorders

• Patients with congenital amino acid metabolism disorders

• Patients with acute shock

• Patients with uncontrollable diabetes mellitus

• Patients with hemophage syndrome

• Patients with hypopotassemia (K < 3.0mEq/L)

• Patients having the history of myocardial infarction

• Patients reported the following laboratory value

  • fasting TG > 250mg/dl, TC > 300mg/dl
  • ALT/AST ≥ 2×ULN, Bilirubin ≥ 3mg/dl (Exception : patients with periampullary carcinoma including biliary tract or pancreas)
  • Creatinine ≥1.5mg/dl
  • Ca > 11.2mg/dl, Na ≥ 145mEq/L, Mg ≥ 2.1mEq/L, K ≥ 5.5mEq/L

• Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug

• Patients having the history of drug or alcohol abuse

• General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, cardiac decompensation

• Patients are in unstable conditions

• Patients with difficult peripheral intravenous

• Patients with parenteral nutrition within 7 days prior to start of the trial

• Participation in another clinical study with an investigational drug or an investigational medical device within 28 days prior to start of study

• Patients judged to be unsuitable for this trial by investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CombiflexOmega peri	CombiflexOmega peri	-
SmofKabiven peripheral	SmofKabiven peripheral	-

Primary Outcome Measures

Name	Time	Method
Comparison of adverse drug reaction	4days

Secondary Outcome Measures

Name	Time	Method
Changes of laboratory parameters (biochemistry, hematology, coagulation)	5days
Changes of vital signs	5days

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of