Review and compare of renal function in pulsatile and non-pulsatile perfusion in patient undergoing coronary artery surgery
Design
Double blind clinical trial by two groups of patients with pulsatile perfusion and non-pulsatile perfusion 25 patients in each group (50 patients generally) in parallel analyzing with spss software.
Settings and conduct
Patiens undergoing coronary artery surgery were accidentally chosen to the study
surgeeon nurses patients and researcher were not aware about the kind of perfusion applied during surgery
Participants/Inclusion and exclusion criteria
Entrance criterions:
Age above 18 years
Coronary artery surgery
Exit criterions:
Suffering MI in the last two weeks
Off pump surgery
Urgent surgery
Untreated diabetes
Abnormal liver function
Reduced level of consciousness before surgery
Intervention groups
Intervention group: Patients undergoing coronary surgery with pulsatile blood flow of pump
After getting anesthesia and opening the chest, patients were connected to the heart-lung mashine that was set on pulsatile mode.
Control group: Patients undergoing coronary surgery with nonpulsatile blood flow of pump
In this group like the intervention group after anesthasia and openning the chest patients were connected to heart-lung mashine that was set nonpulsatile.
Main outcome variables
Renal function by analyzing urine output during surgery and 24 hours after surgery, amounts of GFR at the time of releasing from hospital, amounts of BUN 24 hours after surgery and at the time of releasing from hospital, amounts of serum creatinine 24 hours after surgery and at the time of releasing from hospital, amounts of blood sodium and potassium during surgery and after surgery
analyzing these parameters in both groups and comparing these between two groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048509N1
Registration date:2020-09-19, 1399/06/29
Registration timing:retrospective
Last update:2020-09-19, 1399/06/29
Update count:0
Registration date
2020-09-19, 1399/06/29
Registrant information
Name
Sahra Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 2537
Email address
sahrasalehi90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-01-21, 1398/11/01
Trial completion date
2020-01-21, 1398/11/01
Scientific title
Review and compare of renal function in pulsatile and non-pulsatile perfusion in patient undergoing coronary artery surgery.
Public title
Renal function in pulsatile and non-pulsatile perfusion in patient undergoing coronary artery surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Coronary artery surgery
Exclusion criteria:
Suffering MI in the last two weeks
Off pump surgery
Urgent surgery
untreated diabetes
Abnormal liver function
Reduced level of consciousness before surgery
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Surgeon and the nurse involved in the study were not aware of the kind of perfusion applied to the patient
Blinding (investigator's opinion)
Double blinded
Blinding description
Surgeon and the nurses involved in the study were not aware of the kind of perfusion applied to the patients
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of medical sciences
Street address
Bostan Ave, South Valieasr Blv, Baharestan, Isfahan.
City
Yazd
Province
Yazd
Postal code
8143176944
Approval date
2019-07-06, 1398/04/15
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.121
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease
Primary outcomes
1
Description
Change in renal function
Timepoint
Before surgery, during surgery, 24 hours after surgery, at the releasing time from hospital.
Method of measurement
Getting blood and urine sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group of patients undergoing coronary artery surgery with pulsatile blood flow of pump At the open heart surgery room, after anesthesia and opening the patients chest, patients were connected to the heart-lung mashine and in this study the heart-lung mashine was run in pulsatile blood flow mode in the intervention group, urine and blood samples were collected to measure the related variables to renal function such as: blood sodium and potassium before during and after surgery, Creatinine and BUN before surgery 24 hours after surgery and at releasing time from hospital, urine output before surgery 24 hours after surgery and at releasing time from hospital, and GFR before surgery and at releasing time from hospital.
Category
Treatment - Devices
2
Description
Control group: Group of patients undergoing coronary artery surgery with non-pulsatile blood flow of pump In this group after connecting to the heart-lung mashine the blood flow was administered non-pulsating and all of the variables related to renal function such as: blood sodium and potassium before during and after surgery, Creatinine and BUN before surgery 24 hours after surgery and at releasing time from hospital, urine output before surgery 24 hours after surgery and at releasing time from hospital, and GFR before surgery and at releasing time from hospital were collected and measured. In order to compare the variable between two groups spss software was used to see if the differences are statistically significant or not.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac department of Bandarabbas Shahid Mohammadi general hospital
Full name of responsible person
Sahra Salehi
Street address
Bostan Ave, South Valieasr Blv, Baharestan, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8143176944
Phone
+98 31 3650 2537
Email
Sahrasalehi90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaee
Street address
Bostan Ave, Valieasr Blv, Baharestan, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8143176944
Phone
+98 31 3650 2537
Email
Sahrasalehi90@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
1
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
2
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaee
Street address
Bostan Ave, Valieasr Blv, Baharestan, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8143176944
Phone
+98 31 3650 2537
Email
Sahrasalehi90@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
1
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
Yazd University of Medical Sciences
Full name of responsible person
Sahra Salehi
Position
Cardiopulmonary Perfusionist
Latest degree
Master
Other areas of specialty/work
Cardiology
Street address
Bostan Ave, South Valieasr Blv, Baharestan, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8143176944
Phone
+98 31 3650 2537
Email
Sahrasalehi90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sahra Salehi
Position
Cardiopulmonary Perfusionist
Latest degree
Master
Other areas of specialty/work
Cardiology
Street address
Bostan Ave, South Valieasr Blv, Baharestan, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8143176944
Phone
+98 31 3650 2537
Email
Sahrasalehi90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sahra Salehi
Position
Cardiopulmonary perfusionist
Latest degree
Master
Other areas of specialty/work
Cardiology
Street address
Bostan st., South Valieasr Blv., Baharestan., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8143176944
Phone
+98 31 3650 2537
Fax
Email
sahrasalehi90@gmail.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