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Recruitment status
Unique ID issued by UMIN C000000125
Receipt No. 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

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Basic information
Public 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.
Acronym Effectiveness of immunonutrition and synbiotics in liver transplant recipients.
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.
Scientific Title:Acronym Effectiveness of immunonutrition and synbiotics in liver transplant recipients.
Region
Japan

Condition
Condition Patients scheduled for living-donor liver transplantation.
Classification by specialty
Infectious disease Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect on reduction of postoperative infectious complication between normal diet, immunonutrition without synbiotics and immunonutrition with synbiotics in liver transplant recipients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of postoperative infectious complication.
Key secondary outcomes 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).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 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 .
Interventions/Control_2 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).
Interventions/Control_3 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).
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients scheduled for living-donor liver transplantation with written informed consent.
Key exclusion 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)
Target sample size 105

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Ichiyama
Organization Kyoto University Hospital
Division name Department of Infection Control and Prevention
Zip code
Address 54 Kawahara-Cho, Shogoin, Sakyo-ku, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Fujihara
Organization Kyoto University Hospital
Division name Department of Infection Control and Prevention
Zip code
Address 54 Kawahara-Cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-4237
Homepage URL
Email

Sponsor
Institute Department of Infection Control and Prevention, Kyoto University Hospital
Institute
Department

Funding Source
Organization The Ministry of Education, Science, Sports and Culture.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Transplantation Immunology, Kyoto University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2005 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2005 Year 09 Month 01 Day
Last follow-up date
2007 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 07 Day
Last modified on
2005 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000185

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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