The effect of Aminophylline on renal function after liver transplant surgery
Design
Double blinded randomized clinical trial
Settings and conduct
Methods: 100 patients who are undergoing liver transplantation will included to the study in Namazi Hospital, Shiraz, two groups A and B are considered.
Patients in the intervention group receive 5 mg / kg of aminophylline as bolus after induction of anesthesia and then receive aminophylline infusion at a dose of 0.25 mg / kg / hour to 48 hours post-operatively.
In the control group patients at the same times receive normal saline.
Blinding:According to the selected dose of aminophylline, 0.25 micrograms per kilogram per hour, a 50-cc syringe of aminophylline (1cc /25 mg) is provided for the intervention group in the operating room and placed in a pump syringe for prescribing the drug in ICU.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:All patients who are undergoing liver transplant surgery.
Exclusion Criteria:History of cardiac arrhythmia Tachycardia Renal injury Obstructive uropathy Congenital anomalies of the kidney Creatinine above 1.5 Sodium level less than 135 Patients who use of donated cadaver liver.
Intervention groups
Patients in the intervention group receive 5 mg / kg of aminophylline as bolus after induction of anesthesia and then receive aminophylline infusion at a dose of 0.25 mg / kg / hour to 48 hours post-operatively. In the control group patients at the same times receive normal saline.
Main outcome variables
Primary outcome variable:
The serum glomerular and creatinine clearance levels are measured before surgery, and after the operation, GFR and serum creatinine are measured every day for up to 5 days in the ICU.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N79
Registration date:2019-04-06, 1398/01/17
Registration timing:prospective
Last update:2019-04-06, 1398/01/17
Update count:0
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aminophyllin on renal function after liver transplant surgery
Public title
The effect of aminophyllin on renal function after liver transplant surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who are undergoing liver transplant surgery.
Exclusion criteria:
History of cardiac arrhythmia
Tachycardia
Renal injury
Obstructive uropathy
Congenital anomalies of the kidney
Creatinine above 1.5
Sodium level less than 135
Patients who use of donated cadaver liver
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomly enter the study through the randomization chart which is derived from the www.randomization.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
According to the selected dose of aminophylline, 0.25 micrograms per kilogram per hour, a 50-cc syringe of aminophylline (1cc /25 mg) is provided for the intervention group in the operating room and placed in a pump syringe for prescribing the drug in ICU.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Shiraz University of Medical Sciences
Street address
Vice chancellor for research, 7th floor of central building of Shiraz University of medical sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.SUMS.MED.REC.1396.35
Health conditions studied
1
Description of health condition studied
kidney transplant
ICD-10 code
T86.1
ICD-10 code description
Complications of kidney transplant
Primary outcomes
1
Description
Glomerular filtration rate
Timepoint
Before the operation and daily until 5 days post-operatively
Method of measurement
Cochcroft and Gault formula
2
Description
Serum creatinine level
Timepoint
Before the operation and daily until 5 days post-operatively
Method of measurement
Venous blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group receive 5 mg / kg of aminophylline as bolus after induction of anesthesia and then receive aminophylline infusion at a dose of 0.25 mg / kg / hour to 48 hours post-operatively.
Category
Prevention
2
Description
Control group: Patients at the same times of intervention group receive normal saline with the same volume of aminophylline, and only use usual care during and after liver transplantation
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Amin Valipour
Street address
Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Yones Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
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
Mohammad Hossein Eghbal
Position
Fellow ship of Organ Transplantation anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
hoseineghbal@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Eghbal
Position
Fellow ship of Organ Transplantation anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
hoseineghbal@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in English Teaching, BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Others
Street address
5th floor, Mohammad Raoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 716474270
Email
masihifarzaneh@yahoo.com
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