Comparison of the Effect of 5% Albumin Infusion with Ringer Lactate Serum on Replacement of Patients' Bleeding during Surgery on the Function of Renal and Coagulation System and Their Electrolytes after Surgery
Effect of 5% albumin on replacement of hemorrhage during surgery on renal and coagulation system and patient's serum electrolytes after surgery
Design
Simple randomization using random number table and Phase 3 clinical trial. Groups are parallel. Patients, analyzers and outcome assessor will not be aware of group type.
Settings and conduct
This clinical trial will be conducted at General hospital of Ayatollah Kashani in Shahrekord. Patients will be randomly divided into intervention ( Albumin solution 5%) and control (Ringer lactate serum) groups for assessing preoperative renal function and coagulation status at 6, 12 and 24 hours after surgery.Patients, analyzers and outcome assessor will not be aware of group type.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 and 75 years, anesthesia class 1 and 2, blood urea less than 38.5 mg / dl, blood creatinine less than 1.3 mg / dl
Exclusion criteria: history of liver, kidney, heart disease, coagulation and anticoagulant use
Intervention groups
Intervention group: Albumin 5% will be used to compensate for bleeding. The control group will receive 3 times the amount of bleeding ringer lactate to compensate for bleeding.
Main outcome variables
Changes in Coagulation Tests (PT, PTT, INR), Renal Tests (BUN, Cr, Na, Ca, K)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191009045037N1
Registration date:2019-11-30, 1398/09/09
Registration timing:registered_while_recruiting
Last update:2019-11-30, 1398/09/09
Update count:0
Registration date
2019-11-30, 1398/09/09
Registrant information
Name
Hossein Madineh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3226 4835
Email address
hosseinmadineh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of 5% Albumin Infusion with Ringer Lactate Serum on Replacement of Patients' Bleeding during Surgery on the Function of Renal and Coagulation System and Their Electrolytes after Surgery
Public title
The effect of injectable albumin on renal and coagulation system activity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women 18 to 75 years
The risk of anesthesia is 1 or 2 with the division of the American Anesthesia Association
A blood urea of less than 38.5 mg / dl
Have a blood creatinine of less than 1.3 mg / dL
Blood platelets range between 150,000 and 300,000
Patient INR less than 1.2
The patient's consent form must be signed by the patient
Exclusion criteria:
Patient with a history of liver disease
Patient with a history of heart failure
Patient history of kidney disease
Patient with a history of coagulopathy
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects. Then, within each block, subjects will be randomly assigned to Albumin 5% or Ringer lactate. Random assignment will be done using a random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant was under general anesthesia during the intervention and the outcome assessor and analyzer received the results of the study as group A and B and were not aware of Albumin group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Ayatollah Kashani Ave Shahrekord University of Medical Sciences 8815713471
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2017-01-21, 1395/11/02
Ethics committee reference number
IR.SKUMS.REC.1395.211
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
2
Description of health condition studied
Coagulapathy
ICD-10 code
D68.9
ICD-10 code description
Coagulation defect, unspecified
Primary outcomes
1
Description
The effect of albumin on renal system activity
Timepoint
Preoperatively and 6, 12 and 24 hours postoperatively
Method of measurement
Calometric
Secondary outcomes
1
Description
The effect of albumin on coagulation activity
Timepoint
Preoperatively and 6,12,24 hours postoperatively
Method of measurement
Coagulometer
Intervention groups
1
Description
Intervention group: Intraoperative fluid therapy in the this group would be albumin 5% equal to bleeding volume. To study patients' coagulation status, Prothrombin time (PT), Partial thromboplastin time (PPT), and INR tests. Measurements will be at preoperative times, at 6, 12, and 24 hours after surgery. In addition , concentrations of electrolytes (sodium, potassium and calcium), urinary output, BUN and creatinine will also be collected.
Category
Treatment - Drugs
2
Description
Control group: Intraoperative fluid therapy in the this group would be Ringer lactate with three times of bleeding volume. To study patients' coagulation status, Prothrombin time (PT), Partial thromboplastin time (PPT), and INR tests. Measurements will be at preoperative times, at 6, 12, and 24 hours after surgery. In addition , concentrations of electrolytes (sodium, potassium and calcium), urinary output, BUN and creatinine will also be collected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatolah Kashani hospital
Full name of responsible person
Hossein Madineh
Street address
Parrastar St
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8871347038
Phone
+98 38 3226 4835
Email
hosseinmadineh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Kamal Solati
Street address
Ayatollahe Kashani St
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Hossein Madineh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Parrastar St
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3226 4835
Email
hosseinmadineh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hossein Madineh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Parrastar St
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3226 4835
Email
hosseinmadineh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hossein Madineh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Parrastar St
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3226 4835
Email
hosseinmadineh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Clinical characteristics and laboratory information of patients, sample collection method, inclusion and exclusion criteria, intraoperative bleeding, intraoperative fluid therapy, pre- and postoperative tests, information analysis method and information results
When the data will become available and for how long
2020
To whom data/document is available
Ministry of Health and Medical Education of the Islamic Republic of Iran
Under which criteria data/document could be used
For information on appropriate treatment and permission from the research officer
From where data/document is obtainable
From researcher hosseinmadineh@gmail.com and Shahrekord University of Medical Sciences: info@skums.ac.ir :
What processes are involved for a request to access data/document
Documentary Requirements for Information Required and Letter from his Affiliated Institution After Investigating If a Researcher and Shahrekord University of Medical Sciences Agree Within a Month