Unique ID issued by UMIN | C000000125 |
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Receipt number | R000000185 |
Scientific Title | 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. |
Date of disclosure of the study information | 2005/09/07 |
Last modified on | 2005/09/07 15:32:19 |
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.
Effectiveness of immunonutrition and synbiotics in liver transplant recipients.
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.
Effectiveness of immunonutrition and synbiotics in liver transplant recipients.
Japan |
Patients scheduled for living-donor liver transplantation.
Infectious disease | Hepato-biliary-pancreatic surgery |
Others
NO
To compare the effect on reduction of postoperative infectious complication between normal diet, immunonutrition without synbiotics and immunonutrition with synbiotics in liver transplant recipients.
Efficacy
The rate of postoperative infectious complication.
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).
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
3
Prevention
Food |
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).
18 | years-old | <= |
Not applicable |
Male and Female
Patients scheduled for living-donor liver transplantation with written informed consent.
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)
105
1st name | |
Middle name | |
Last name | Satoshi Ichiyama |
Kyoto University Hospital
Department of Infection Control and Prevention
54 Kawahara-Cho, Shogoin, Sakyo-ku, Kyoto
1st name | |
Middle name | |
Last name | Naoko Fujihara |
Kyoto University Hospital
Department of Infection Control and Prevention
54 Kawahara-Cho, Shogoin, Sakyo-ku, Kyoto
075-751-4237
Department of Infection Control and Prevention, Kyoto University Hospital
The Ministry of Education, Science, Sports and Culture.
Department of Transplantation Immunology, Kyoto University Hospital
NO
2005 | Year | 09 | Month | 07 | Day |
Unpublished
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2005 | Year | 09 | Month | 01 | Day |
2007 | Year | 09 | Month | 01 | Day |
2005 | Year | 09 | Month | 07 | Day |
2005 | Year | 09 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000185
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