Comparison of the Effect of Pulsatile and Non-pulsatile Perfusion Flow on Renal Function during Coronary Artery Bypass Grafting Surgery in Patients with Left Ventricular Dysfunction
Determination and Comparison of Effect of Pulsatile and Non-pulsatile Perfusion Flow on Renal Function in Coronary Artery Bypass Grafting Surgery in Patients with Left Ventricular Dysfunction
Design
This is a randomized, double-blind clinical study.Patients were randomly divided into two groups by using coin pellet. The sample size is 64 patients, 40 of them received non-pulsatile flow and 24 of them received pulsatile flow.
Settings and conduct
Type: randomized clinical trial /double-blind by co-researcher/done for 64 patients: 40 received non-pulsatile and 24 pulsatile flow/location: heart surgery room of Namazi hospital
Participants/Inclusion and exclusion criteria
Study Entry Criteria: Patients referred to the heart surgery room for elective CABG in Shiraz University of Medical Sciences affiliated hospitals
Participation Satisfaction in the research project
Left ventricular dysfunction(EF≤40%).
Coronary artery bypass surgery
age range 40-75 years
Exit criteria: Patient's unwillingness to continue participation
Simultaneous Surgical operation of the valve and coronary artery
Risk of anesthesia greater than three
Systemic infection or Sepsis
Renal dysfunction (Cr> 1.5).
Liver Dysfunction
Redo
the recent records of stroke
Concurrent autoimmune disease
History of taking any immunosuppressive medicine, chemotherapy or radiotherapy.
Intervention groups
the Control and the Case Group: Among patients candid CABG who suffer from Left Ventricular Dysfunction, the group who received the Pulsatile Flow was selected as the case group and the group that received the non-Pulsatile Flow was selected as the control group
Main outcome variables
Renal parameters include Cr, BUN, GFR and 24-hour UO.
Non-renal parameters during and after surgery include blood intake, colloid, crystalloid, bleeding rate, urine rate, inotropic and furosemide intake rate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190218042749N1
Registration date:2019-07-15, 1398/04/24
Registration timing:retrospective
Last update:2019-07-15, 1398/04/24
Update count:0
Registration date
2019-07-15, 1398/04/24
Registrant information
Name
Marzieh Zamani Jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5426 7727
Email address
marziehzamani@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
2018-01-21, 1396/11/01
Actual recruitment end date
2018-08-18, 1397/05/27
Trial completion date
2018-08-21, 1397/05/30
Scientific title
Comparison of the Effect of Pulsatile and Non-pulsatile Perfusion Flow on Renal Function during Coronary Artery Bypass Grafting Surgery in Patients with Left Ventricular Dysfunction
Public title
The Effect of Pulsatile and Non-pulsatile Perfusion Flow on Renal Function during Coronary Artery Bypass Grafting Surgery in Patients with Left Ventricular Dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referring to Operation room for Elective CABG in dependent hospitals to Shiraz University of Medical Sciences
participation satisfaction in attending the project
left Ventricular dysfunction
Bypass Coronary Grafting Surgery
enjoying EF pulsatile lower than 40 percent( based on Suggestions from American Cardiography Association) equivalent to severe left ventricular dysfunction
Ages from 40 to 75
Exclusion criteria:
lack of patient's tendency to continue the study
simultaneous surgery of Valve and Coronary
Anesthesia risk more than 3
Sepsis
Renal dysfunction (Cr>1.5)
Redo
Liver Dysfunction
Records of brain stroke
Concurrent autoimmune diseases
Records of immunosuppressive drugs, Chemotherapy or radiotherapy
emergency patients
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients participating in the study were divided into two intervention and control groups by throwing coins.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study: participants, the researcher, medical staff(physicians and nurses), those responsible for data collection, the individuals who analyzed the final results, and those who prepared the paper draft.
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 Medical Sciences University, Across from Felestin St., Zand St.,
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2017-10-23, 1396/08/01
Ethics committee reference number
IR.SUMS.REC.1397.108
Health conditions studied
1
Description of health condition studied
Patients who have Coronary Artery Disease candidate of CABG with left ventricular dysfunction
ICD-10 code
I25.708
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s), unspecified, with other forms of angina pectoris
Primary outcomes
1
Description
Renal parameter UO24h
Timepoint
Before bypass surgery, During bypass surgery, three days after bypass surgery,
Method of measurement
Laboratory variables were sent to the laboratory and got analyzed with the related devices. 24-hour urine volume after the surgery was measured by the ICU nurses.
2
Description
Renal parameter BUN
Timepoint
Before bypass surgery, During bypass surgery, three days after bypass surgery,
Method of measurement
Laboratory variables were sent to the laboratory and got analyzed with the related devices. 24-hour urine volume after the surgery was measured by the ICU nurses.
3
Description
Renal parameter GFR
Timepoint
Before bypass surgery, During bypass surgery, three days after bypass surgery,
Method of measurement
Laboratory variables were sent to the laboratory and got analyzed with the related devices. 24-hour urine volume after the surgery was measured by the ICU nurses.
4
Description
Renal parameter Cr
Timepoint
Before bypass surgery, During bypass surgery, three days after bypass surgery,
Method of measurement
Laboratory variables were sent to the laboratory and got analyzed with the related devices. 24-hour urine volume after the surgery was measured by the ICU nurses.
Secondary outcomes
1
Description
BMI
Timepoint
Before bypass surgery
Method of measurement
Based on Patient's File
2
Description
Bleeding rate
Timepoint
three days after bypass surgery in ICU
Method of measurement
Bleeding rate was determined based on the scaled chest bottle tube.
3
Description
Gender
Timepoint
Before bypass surgery
Method of measurement
Based on Patient's File
4
Description
Age
Timepoint
Before bypass surgery
Method of measurement
Based on Patient's File
5
Description
EF
Timepoint
Before bypass surgery
Method of measurement
Based on Patient's File
Intervention groups
1
Description
Control group: CABG candid patients who suffer from left ventricular dysfunction and received non-pulsatile flow during the surgery via Pump machine
Category
Treatment - Surgery
2
Description
Intervention group: CABG candid patients who suffers from left ventricular dysfunction and received pulsatile flow during the surgery via Pump machine
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Marzieh Zamani
Street address
Namazi sq., Shiraz
City
Shiraz
Province
Fars
Postal code
13311 – 71936
Phone
+98 71 3647 4332
Email
marziehzamani@jums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Research Secretary, 7th Floor, Central Building of Shiraz University of Medical Sciences, Zand St., Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Email
vcrdep@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
Marzieh Zamani Jahromi
Position
MSc student of Perfusion
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Motahari St.,Pardis Site, After Nursing College, Jahrom, Iran
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
Patients identity information such as first name, last name, file No. and Hospitalization code are not recorded.
When the data will become available and for how long
from March-2019
To whom data/document is available
Professors, University students and all researches who study the same issue.
Under which criteria data/document could be used
In order to get information about different aspects of specialized and applied purposes, hypothesis, research methods, and results in order to be used with citations as a reference in future studies.
From where data/document is obtainable
Library of Shiraz University of Medical Sciences and Anaesthesia Department Library located at Shiraz University of Medical Sciences
What processes are involved for a request to access data/document
The applicant can find access to data after presenting his/her personal ID card with this explanation that he/she is not allowed to take photos of the document or to take it out of the library.