UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000125
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

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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 or person

Institute

Department of Infection Control and Prevention, Kyoto University Hospital

Institute

Department

Personal name



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

Value
https://center6.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