Determining The Effect of Vacuum Assisted Venous Drainage (VAVD) on Kidney Function and Blood Transfusion in Patients Undergoing Cardiac reoperation
Design
A randomized, controlled, double-blinded, paralleled clinical trial on 90 patients
Settings and conduct
90 patients who are candidates for cardiac reoperation referred to Tehran Shaheed Rajaie Cardiovascular Medical and Research Center will be divided into two groups if they meet the inclusion criteria using random blocks of size 6. All anesthesia and cardiopulmonary bypass (CPB) conditions will be similar in patients and the only difference will be the use of VAVD during CPB in the intervention group. Patients and intensive care unit (ICU) nurses will not be aware of the use or non-use of VAVD during CPB
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are candidates for cardiac reoperation, Informed consent to participate in the study, Age more than 18 years, Ejection Fraction (EF) greater than 35%; Exclusion criteria: Presence of large vessel surgeries requiring Deep Hypothermic Circulatory Arrest (DHCA), third time reoperation and more, Presence of kidney failure before surgery (patient with previous diagnosis of kidney failure or creatinine higher than 1.5 mg/dL), Presence of History of bleeding disorders before surgery, Presence of Anemia before surgery (hemoglobin less than 10 gr/dL), Presence of history of cerebrovascular diseases
Intervention groups
In the patients undergoing cardiac reoperation in the intervention group, venous drainage will be performed using VAVD, but in the control group, venous drainage will be based on gravity and the height difference between the patient and the oxygenator
Main outcome variables
The average level of serum creatinine up to 48 hours after surgery and the occurrence of acute kidney injury based on the KDIGO (Kidney Disease Improving Global Outcomes) criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230915059434N1
Registration date:2023-10-14, 1402/07/22
Registration timing:prospective
Last update:2023-10-14, 1402/07/22
Update count:0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
Zahra Majidi parizi
Name of organization / entity
Shaheed Rajaie Cardiovascular Medical and Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 23921
Email address
zahra.majidiparizi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-01, 1402/08/10
Expected recruitment end date
2024-05-30, 1403/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Vacuum Assisted Venous Drainage on Kidney Function and Blood Transfusion in Patients Undergoing Cardiac reoperation
Public title
The Effect of Vacuum Assisted Venous Drainage (VAVD) on Kidney Function and Blood Transfusion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for cardiac reoperation
Informed consent to participate in the study
Age more than 18 years
(Left Ventricular Ejection Fraction) LVEF greater than 35%
Exclusion criteria:
Presence of large vessel surgeries requiring Deep Hypothermic Circulatory Arrest (DHCA), third time reoperation and more
Presence of kidney failure before surgery (patient with previous diagnosis of kidney failure or creatinine higher than 1.5 mg/dL)
Presence of History of bleeding disorders before surgery
Presence of Anemia before surgery (hemoglobin less than 10 gr/dL)
Presence of history of cerebrovascular diseases
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups using a random block method with a size of 6: 45 patients in the VAVD group (receiving VAVD during cardiopulmonary bypass) and 45 patients in the GD group (venous drainage with gravity only)
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining informed consent, due to being under anesthesia and surgery, the patients will not know whether they will be assigned to the control or intervention group and ICU nurses will not know about the use or non use of VAVD during cardiopulmonary bypass.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Rajaie Cardiovascular Medical and Research Center
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center, Valiasr Ave, Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2023-08-05, 1402/05/14
Ethics committee reference number
IR.RHC.REC.1402.052
Health conditions studied
1
Description of health condition studied
Cardiac reoperation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum creatinine level
Timepoint
Preoperatively, upon admission to the intensive care unit, 24 and 48 hours later
Method of measurement
laboratory test
Secondary outcomes
1
Description
Blood Urea Nitrogen
Timepoint
Preoperatively, upon admission to the intensive care unit, 24 and 48 hours later
Method of measurement
laboratory test
2
Description
The amount of urinary output
Timepoint
During cardiopulmonary bypass, 6, 12, 24 and 48 hours after surgery
Method of measurement
Patient file information
3
Description
Central Venous Pressure
Timepoint
Before starting bypass, During and after the completion of cardiopulmonary bypass, upon entering the intensive care unit, 6, 12, 24 and 48 hours after surgery
Method of measurement
Patient monitoring information
4
Description
Mean Arterial Pressure
Timepoint
Before starting bypass, During and after the completion of cardiopulmonary bypass, upon entering the intensive care unit, 6, 12, 24 and 48 hours after surgery
Method of measurement
Patient monitoring information
5
Description
Prime volume used in cardiopulmonary bypass circuit
Timepoint
The volume of fluid used in the circuit at the start of cardiopulmonary bypass
Method of measurement
Patient file information
6
Description
Hemoglobin
Timepoint
Preoperatively, before starting bypass, during and after completion of cardiopulmonary bypass, upon admission to the intensive care unit, 6, 12, 24, and 48 hours after surgery
Method of measurement
laboratory test
7
Description
The amount of blood transfusion
Timepoint
Up to 48 hours after surgery
Method of measurement
Patient file information
Intervention groups
1
Description
Intervention group: In the intervention group, by using the Polystan VAVD Controller and reducing the height difference between the patient and the venous reservoir, the length of the cardiopulmonary bypass circuit lines will be reduced to reduce the volume of the primary bypass circuit by 250 cc. Throughout the use of Vacuum Assisted Venous Drainage(VAVD), the negative pressure of the venous reservoir will be monitored and controlled in the range of -30 to -45 mm Hg.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Zahra Majidi Parizi
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center, Valiasr Ave, Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
zahra.majidiparizi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shaheed Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Zahra Majidi Parizi
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center, Valiasr Ave, Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
zahra.majidiparizi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shaheed Rajaie Cardiovascular Medical and Research Center
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
Shaheed Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Zahra Majidi Parizi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Extracorporcal Circulation Technology
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center, Valiasr Ave, Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
zahra.majidiparizi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Zahra Majidi Parizi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Extracorporcal Circulation Technology
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center, Valiasr Ave, Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
zahra.majidiparizi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shaheed Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Zahra Majidi Parizi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Extracorporcal Circulation Technology
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center, Valiasr Ave, Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
zahra.majidiparizi@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
All information related to the study procedure and its consequences can be provided
When the data will become available and for how long
After publishing the articles from the study, the data will be available.
To whom data/document is available
All researchers in the field of medical sciences
Under which criteria data/document could be used
With scientific purposes and with the author's knowledge
From where data/document is obtainable
To access the data, you can contact the researcher Zahra Majidi via e-mail zahra.majidiparizi@gmail.com and the address of Tehran, Shaheed Rajaie Heart Hospital.
What processes are involved for a request to access data/document
After communicating with the researcher via email or address and fully introducing the applicant and stating the purpose of using the data, it will be possible to access the data in less than a month.