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Comparison of albumin-normal saline and albumin-gelatin injection on early outcome after liver transplant surgery

Protocol summary

Study aim
Comparison of albumin-normal saline and albumin-gelatin injection on early outcome after liver transplant surgery
Design
A randomized controlled clinical trial with 100 randomized double-blind,placebo-controlled trials will be performed.Simple randomization will be done using a random table.
Settings and conduct
This study will conduct to evaluate the prevalence of acute post-operative kidney injury in albumin-normal saline and albumin-gelatin patients in liver transplant surgery in Bo Ali Sina Hospital, Shiraz. Induction and maintenance of anesthesia and all necessary actions in the operating room are performed by an anesthesiologist who is not a project associate ,and the researcher who is responsible for recording and tracking patients in the transplant intensive care unit is unaware of the technique used during surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria:The final stage of liver disease, Age over 18 years ,Patients candidate for liver transplantation from brain death donors. Exclusion criteria: Liver recipients from live donors ,Patients undergoing redo transplantation, History of upper abdominal surgery ,A history of allergies to colloids, History of kidney dysfunction confirmed by laboratory and ultrasound sonography.
Intervention groups
In group 1, 10 grams of albumin in 1000 cc normal saline is infused from the beginning to the end of the procedure. In group two, the main preservative fluid is gelatin, which is injected based on the hemodynamic and CVP parameters from the beginning of the clamping to the end of surgery, one liter of normal saline containing 10 g of albumin is infused too.
Main outcome variables
Glomerular filtration rate, Serum creatinine level, Blood Urea Nitrogen, Liver Function Tests

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141009019470N88
Registration date: 2019-09-17, 1398/06/26
Registration timing: prospective

Last update: 2019-09-17, 1398/06/26
Update count: 0
Registration date
2019-09-17, 1398/06/26
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
2019-09-21, 1398/06/30
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of albumin-normal saline and albumin-gelatin injection on early outcome after liver transplant surgery
Public title
Comparison of albumin-normal saline and albumin-gelatin injection on early outcome after liver transplant surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The final stage of liver disease Age over 18 years Patients candidate for liver transplantation from brain death donors
Exclusion criteria:
Liver recipients from live donors Patients undergoing redo transplantation History of upper abdominal surgery A history of allergies to colloids History of kidney dysfunction confirmed by laboratory and ultrasound tests
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two groups of albumin-normal saline and gelatin-albumin group based on simple randomization by using randomized quadruple blocks of randomization table which is derived from www.randomization.org.
Blinding (investigator's opinion)
Double blinded
Blinding description
Induction and maintenance of anesthesia and all necessary actions in the operating room are performed by an anesthesiologist who is not a project associate. And the researcher who is responsible for recording and tracking patients in the transplant intensive care unit is unaware of the technique used during surgery.
Placebo
Not 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
2019-08-03, 1398/05/12
Ethics committee reference number
IR.SUMS.MED.REC.1398.323

Health conditions studied

1

Description of health condition studied
Liver transplant
ICD-10 code
Z94.4
ICD-10 code description
Liver transplant status

Primary outcomes

1

Description
Glomerular filtration rate
Timepoint
On the first day, second day, third day, fifth day and the last day of hospitalization
Method of measurement
Cochcroft and Gault formula

2

Description
Serum creatinine level
Timepoint
On the first day, second day, third day, fifth day and the last day of hospitalization
Method of measurement
Venous blood sample

3

Description
Blood Urea Nitrogen
Timepoint
On the first day, second day, third day, fifth day and the last day of hospitalization
Method of measurement
Venous blood sample

4

Description
Liver Function Tests: (AST, ALT, ALKP, INR, Bilirubin), Albumin
Timepoint
On the first day, second day, third day, fifth day and the last day of hospitalization
Method of measurement
Venous blood sample

Secondary outcomes

1

Description
ICU stay
Timepoint
At arrival time until the discharge from intensive care unit
Method of measurement
Observation

2

Description
Time interval between completion of operation and extubation
Timepoint
Between completion of operation to extubation
Method of measurement
Observation

3

Description
Hospital Stay
Timepoint
Hospital discharge time
Method of measurement
Observation

Intervention groups

1

Description
Intervention group: In group 1, 10 grams of albumin in 1000 cc normal saline is infused from the beginning to the end of the procedure.
Category
Prevention

2

Description
Intervention group: In group two, the main preservative fluid is gelatin, which is injected based on the hemodynamic and CVP parameters from the beginning of the clamping to the end of surgery, one liter of normal saline containing 10 g of albumin is infused too.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Bu Ali Sadra Hospital
Full name of responsible person
Samaneh Ghazanfar Tehran
Street address
Phase 2, Sadra New City .Shiraz
City
Shiraz
Province
Fars
Postal code
7134844112
Phone
+98 71 3640 7061
Email
BuAliSadra@sums.ac.ir

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
vrcd@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
Samaneh Ghazanfar Tehran
Position
Transplant Anesthesia Fellowship
Latest degree
Specialist
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
Tehranisamaneh88rasht@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Bagher Khosravi
Position
Transplant Anesthesia Fellowship/Cardio-anesthesiologist
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
khosravimb@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
Research Assistant
Latest degree
Master
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
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
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