continuous versus rapid infusion of albumin on the clinical outcomes of pediatric undergoing liver transplantation
Design
A double-blind clinical trial that includes 42 liver transplant candidates under the age of 18. Permutation blocking randomization method will be used to divide patients into two groups.
Settings and conduct
at Bou Ali Sina Organ Transplantation Hospital in Shiraz and need to receive albumin for at least 48 hours.Patients are divided into two groups of 21 people using a random number table of unclassified randomization and with a random ratio of 1:1. The first group received albumin at a dose of 0.5 to 1 g/kg slowly for 180 minutes and the second group received the same dose quickly for 30 minutes. Albumin injection is done up to 48 hours after transplantation and in at least 3 doses.
Participants/Inclusion and exclusion criteria
Including factors: All liver transplant candidates under 18 years old
Excluding factors: re-transplantation
Simultaneous liver and kidney transplantation
Hemorrhagic shock after transplantation during hospitalization
Known hypersensitivity to albumin
Intervention groups
Patients are randomly divided into two groups: the first group received albumin at a dose of 0.5 to 1 g/kg slowly for 180 minutes and the second group received the same dose quickly for 30 minutes. Albumin injection is done up to 48 hours after transplantation and at least in 3 doses.
Main outcome variables
1- Examination of 24-hour urine volume after liver transplantation
2- Incidence and stability of abdominal ascites, pleural effusion and leakage rate after transplantation based on radiological findings
3- Incidence of portal vein thrombosis and the amount of hepatic artery based on radiological findings
4- Increase in albumin number after transplantation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120731010453N5
Registration date:2023-07-04, 1402/04/13
Registration timing:registered_while_recruiting
Last update:2023-07-04, 1402/04/13
Update count:0
Registration date
2023-07-04, 1402/04/13
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
2023-07-01, 1402/04/10
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
continuous versus rapid infusion of albumin on the clinical outcomes of pediatric undergoing liver transplantation, a randomized clinical trial.
Public title
continuous versus rapid infusion of albumin on the clinical outcomes of pediatric undergoing liver transplantation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ll patients which candidate to liver transplant younger than 18 years old
Exclusion criteria:
Re-transplantation
simultaneous liver and kidney transplantation
Hemorrhagic shock after liver transplantation during hospitalization
known Hypersensitivity to albumin
Age
To 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
After liver transplant surgery, all eligible patients are divided into two groups of 21 people, intervention and control, using a random number table, permutation blocking method. This table was prepared by a biostatistician and the patients are divided into one of two groups receiving fast and slow albumin according to the order of sampling according to the table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The albumin prescription will be given by the gastroenterologist or pediatric special care specialist, and the head of the department, who does not have a role in the evaluation of results and data analysis, will assign the patients to It divides the above two groups, so the prescribing person as well as the researchers of this study are blinded in terms of what albumin regimen the patient receives.
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
2023-05-30, 1402/03/09
Ethics committee reference number
IR.SUMS.REC.1402.098
Health conditions studied
1
Description of health condition studied
liver transplantation
ICD-10 code
T86.49
ICD-10 code description
Other complications of liver transplant
Primary outcomes
1
Description
Albumin level after transplantation
Timepoint
during hospitalization
Method of measurement
By measuring plasma level of albumin
2
Description
24-hour urine volume
Timepoint
During hospitalization
Method of measurement
By reviewing patient information
Secondary outcomes
1
Description
Required dose of intravenous or oral diuretic after transplantation
Timepoint
during hospitalization
Method of measurement
Based on the drug chart
2
Description
The required dose of inotropes and vasopressors after liver transplantation
Timepoint
during hospitalization
Method of measurement
Based on the drug chart
3
Description
Hospital and ICU stay
Timepoint
During hospital and ICU stay
Method of measurement
By reviewing patient information
4
Description
Duration of ventilation
Timepoint
during hospitalization
Method of measurement
By reviewing patient information
5
Description
Hemodynamic status and patient resuscitation after shock
Timepoint
during hospitalization
Method of measurement
By reviewing patient information
6
Description
Status of transplanted liver
Timepoint
during hospitalization
Method of measurement
By reviewing patient information
7
Description
Death rate
Timepoint
during hospitalization
Method of measurement
By reviewing patient information
8
Description
Incidence of post-transplant infections
Timepoint
during hospitalization
Method of measurement
By reviewing patient information
9
Description
The incidence and stability of abdominal ascites
Timepoint
during hospitalization
Method of measurement
By reviewing patient information
10
Description
Pleural effusion
Timepoint
during hospitalization
Method of measurement
By reviewing patient information
11
Description
Incidence of portal vein thrombosis
Timepoint
during hospitalization
Method of measurement
By reviewing patient information
12
Description
Leakage rate after transplant
Timepoint
during hospitalization
Method of measurement
By reviewing patient information
Intervention groups
1
Description
Intervention group: They receive albumin at a dose of 0.5 to 1 g/kg slowly over 180 minutes.
Category
Treatment - Drugs
2
Description
Control group: They receive albumin at a dose of 0.5 to 1 g/kg rapidly for 30 minutes
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
mojtabashafiekhani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
mohammad mehdi hashempour
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
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Karafrin street, Roknabad, Shiraz
City
Shiraz
Province
Fars
Postal code
71546-57145
Phone
+98 71 3242 4255
Fax
+98 71 1242 4126
Email
mojtabashafiekhani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mojtaba Shafiekhani
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
clinical pharmacy
Street address
دانشکده داروسازی شیراز, رکن آباد , خیابان کارآفرین
City
shiraz
Province
Fars
Postal code
71546-57145
Phone
+98 71 3242 4255
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
assistant professor
Latest degree
Specialist
Other areas of specialty/work
clinical pharmacy
Street address
School of Pharmacy, Karafrin street, Roknabad, 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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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