A randomised controlled trial to evaluate the effectiveness of perioperative immunonutrition and synbiotics in living-donor liver transplant recipients on reduction of postoperative infectious complication.

UMIN ID: C000000125

Registered date:07/09/2005

Basic Information

• Health condition(s) or Problem(s) studied: Patients scheduled for living-donor liver transplantation.
• Date of first enrollment: 2005/09/01
• Target sample size: 105
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Enteral nutrition (Elental, Ajinomoto Pharma, Japan) start via an intraoperatively placed ileostomy as soon as tolerated, within 5 days after surgery at the latest. Feeding begin at 10ml/hr, advance to full feeding and continue until oral intake is allowed .
Before surgery, the patient of this group is asked to drink 1000ml/day for 5 consecutive days of immunonutrition (Oral Impact, Ajinomoto Pharma, Japan). In the postoperative course, the same formula (Oral Impact, Ajinomoto Pharma, Japan) start via an intraoperatively placed ileostomy as soon as tolerated, within 5 days after surgery at the latest. Feeding begin at 10ml/hr, advance to full feeding and continue until oral intake is allowed. If enteral feeding continue after postoperative day 15, enteral formula change from immunonutrition to normal formula (Elental, Ajinomoto Pharma, Japan).
Before surgery, the patient of this group is asked to drink 1000ml/day for 5 consecutive days of immunonutrition (Oral Impact, Ajinomoto Pharma, Japan) supplemented with synbiotics (LactoPlas, Saraya, Japan). In the postoperative course, the same formula (Oral Impact, Ajinomoto Pharma, Japan) supplemented with synbiotics (LactoPlas, Saraya, Japan) start via an intraoperatively placed ileostomy as soon as tolerated, within 5 days after surgery at the latest. Feeding begin at 10ml/hr, advance to full feeding and continue until oral intake is allowed. If enteral feeding continue after postoperative day 15, enteral formula change from immunonutrition with synbiotics to normal formula (Elental, Ajinomoto Pharma, Japan).

Outcome(s)

• Primary Outcome: The rate of postoperative infectious complication.
• Secondary Outcome: Amount of antibiotic therapy, Duration of hospital stay, Acquisition of resistant bacteria, Postoperative mortality, The rate of postoperative non- infectious complication (wound dehiscence, rejection, bleeding, re-operation, anastomotic leak).

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: transplantation for fulminant hepatitis, re-transplantation, ABO incompatibility, weight loss >=10% (with respect to usual body weight) in the past 6 months, respiratory dysfunction (arterial PaO2 <70mmHg), renal dysfunction (serum creatinine level >3mg/dl, hemodialysis), cardiac dysfunction (New York Heart Class >=3), pregnancy, ongoing infection, neoadjuvant radiochemotherapy, allergy to components of immunonutrition (protein derived from milk, soybean, peanuts, gelatin)

Related Information

• Primary Sponsor: Department of Infection Control and Prevention, Kyoto University Hospital
• Secondary Sponsor: Department of Transplantation Immunology, Kyoto University Hospital
• Source(s) of Monetary Support: The Ministry of Education, Science, Sports and Culture.