The purpose of this study is to compare the efficacy of two different antibiotic prophylactic regimens for bacterial infections in liver transplant recipients.
Design
single-blinded randomized clinical trial which included 182 candidates for liver transplantation,"simple randomization" method will be use to divide the patients into two groups.
Settings and conduct
All patients will be divided into two groups after randomization. The first group will receive Ampicillin-Sulbactam (3 g every 6 hours) with Ceftizoxime (2 g every 8 hours) and the second group will receive Ampicillin - Sulbactam (3 g every 6 hours) with Gentamicin (5 mg/kg/day intravenously once daily ) for 48 hours. All patients will be followed for bacterial infections for one month after liver transplantation.
This study will be done at Bou Ali Sina hospital which affiliated to Shiraz University of Medical Sciences, Shiraz, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients who are candidates for liver transplantation.
Exclusion criteria: patients with known renal failure or require dialysis, and also any prior history of allergic drug reactions to one of the antibiotics used in this study.
Intervention groups
Patients were randomly assigned in two groups receiving Ampicillin-Sulbactam (3 g every 6 hours) with Ceftizoxime (2 g every 8 hours) or Ampicillin - Sulbactam (3 g every 6 hours) with Gentamicin (5 mg/ kg/day intravenously once daily )for 48 hours. All medications adjusted according to renal function.
Main outcome variables
Primary outcomes included: Length of hospital stay,mortality rate during the study period, the pattern of sensitivity and resistance of all pathogens isolated from patients with positive culture and type and number of them, any clinical or laboratory manifestation suggests bacterial infections
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120731010453N2
Registration date:2018-11-09, 1397/08/18
Registration timing:prospective
Last update:2018-11-09, 1397/08/18
Update count:0
Registration date
2018-11-09, 1397/08/18
Registrant information
Name
Mojtaba Shafiekhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4255
Email address
mshafikhan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of two different antibiotic prophylactic regimens for bacterial infections in liver transplant recipients
Public title
Efficacy of two different antibiotic prophylactic regimens in liver transplant recipients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients which candidate to liver transplant
older than 18 years old
Exclusion criteria:
Positive history of allergic reactions to antibiotics which use in this study
renal failure patients with hemo-dialysis
serum creatinine levels more than 1.5 mg/dL,blood urea nitrogen (BUN) more than 25 mg/dL
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
182
Randomization (investigator's opinion)
Randomized
Randomization description
Before the beginning of liver transplant surgery, all eligible patients were divided into two intervention and control groups by operating room technician using the random numbers table that was at his disposal.
Blinding (investigator's opinion)
Single blinded
Blinding description
In our study, liver transplant surgeons do not know the patients took which of antibiotic prophylactic regimens before surgery
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-09-30, 1397/07/08
Ethics committee reference number
IR.SUMS.REC.1397.644
Health conditions studied
1
Description of health condition studied
liver transplantation
ICD-10 code
T86.43
ICD-10 code description
Liver transplant infection
Primary outcomes
1
Description
Incidence of bacterial infections in the first month after liver transplantation
Timepoint
During first month after liver transplantation
Method of measurement
Centers for Disease Control and Prevention (CDC) definitions for nosocomial infections.
Secondary outcomes
1
Description
mortality rate in liver transplant patients
Timepoint
Duration of hospitalization
Method of measurement
By reviewing patient file information
2
Description
Length of intensive care unit stay
Timepoint
Duration of hospitalization
Method of measurement
By reviewing patient file information
3
Description
Length of hospital stay
Timepoint
Duration of hospitalization
Method of measurement
By reviewing patient file information
Intervention groups
1
Description
first Intervention group: Ampicillin-sulbactam(3 g every 6 hours) with Ceftizoxime (2 g every 8 hours)
Category
Treatment - Drugs
2
Description
Second Intervention group: Ampicillin-sulbactam(3 g every 6 hours) with Gentamicin (5 mg/Kg.once daily)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu Ali Sina Organ Transplant hospital
Full name of responsible person
Mojtaba Shafiekhani
Street address
Abu Ali Sina Organ Transplant, Sadra Highway
City
Shiraz
Province
Fars
Postal code
71994-67985
Phone
+98 71 3344 0000
Email
info@booali.org
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Central building of Shiraz University of Medical Sciences Zand St.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2713
Email
relation@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mojtaba Shafiekhani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Karafrin street ; Roknabad ;School Of Pharmacy; Shiraz
City
Shiraz
Province
Fars
Postal code
71546-57145
Phone
+98 71 3242 4255
Fax
+98 71 1242 4126
Email
mshafikhan@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mojtaba Shafiekhani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Karafrin street ; Roknabad ;School Of Pharmacy; Shiraz
City
Shiraz
Province
Fars
Postal code
71546-57145
Phone
+98 71 3242 4255
Fax
+98 71 1242 4126
Email
mshafikhan@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mojtaba Shafiekhani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Karafrin street ; Roknabad ;School Of Pharmacy; Shiraz
City
Shiraz
Province
Fars
Postal code
71546-57145
Phone
+98 71 3242 4255
Fax
+98 71 1242 4126
Email
mshafikhan@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available