Objective: To determine the ideal method for cardiac arresting during CABG in order to decrease the incidence of low cardiac output syndrome following surgery.
Design: Double blind randomized clinical trial, parallel recruitment. Double blind means that neither data collectors and analyzers nor the patients are aware of the allocation criteria.
Main inclusion criteria: Coronary artery disease patients scheduled for first-time elective isolated on-pump CABG.
Main exclusion criteria: Unstable patients undergoing urgent CABG.
Sample size: At least 89 individuals in either intervention or control group.
Intervention: Continuous crystalloid cardioplegia infusion through saphenous vein grafts, after each distal anastomosis completed, in addition to conventional intermittent antegrade method via aortic root consisting of blood cardioplegia.
Duration of study: Approximately one year.
Primary end-points: The need for intra-aortic balloon pump and inotrope during and after weaning.
Main secondary end-points: The rate of postoperative arrhythmia, the peak level of serum biomarkers of myocardial injury, i.e. CK, CK-MB, and cardiac troponin I (cTnI), at 12 hours following surgery, arterial level of base excess (BE) in the ICU, ventilation time, the length of ICU and hospital stay and finally hospital mortality.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102625488N2
Registration date:2017-11-04, 1396/08/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-04, 1396/08/13
Registrant information
Name
Mehrzad Sharifi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 6055
Email address
m.sharifi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2017-11-01, 1396/08/10
Expected recruitment end date
2018-11-01, 1397/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of simultaneous antegrade.venous graft cardioplegia infusion to conventional method in coronary artery bypass grafting
Public title
Effect of method of cardiac arresting on outcomes following bypass surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Coronary artery disease patients scheduled for first-time elective isolated on-pump CABG
Exclusion criteria:
1. Redo CABG
2. Urgent CABG
3. Off-pump CABG
4. Combined operations including CABG in addition to valve repair or replacement
5. Unexpected intra-operative complications e.g. aortic rupture during cannulation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
178
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Simple randomization technique using SAS software version 9.4 will be applied for randomized allocation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Shahid Shiroodi st., Alamolhoda st.
City
Arak
Postal code
Approval date
2017-10-22, 1396/07/30
Ethics committee reference number
IR.ARAKMU.REC.1396.144
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease
2
Description of health condition studied
Coronary artery bypass graft
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass and valve grafts
Primary outcomes
1
Description
The need for balloon pump
Timepoint
During and after weaning
Method of measurement
Number (percentage)
2
Description
The need for inotrope
Timepoint
During and after weaning
Method of measurement
Number (percentage)
Secondary outcomes
1
Description
Other complications including neurologic, renal, and pulmonary complications
Timepoint
Within one month after surgery
Method of measurement
Number (percentage)
2
Description
The amount of bleeding
Timepoint
Within 24 hours following surgery
Method of measurement
mL
3
Description
Serum level of potassium
Timepoint
Immediately upon arrival to ICU
Method of measurement
mEq/L
4
Description
The rate of perioperative myocardial infarction
Timepoint
During hospitalization
Method of measurement
Number (percentage)
5
Description
Hospital mortality
Timepoint
During hospitalization
Method of measurement
Number (percentage)
6
Description
The rate of postoperative arrhythmia
Timepoint
During ICU stay
Method of measurement
Number (percentage)
7
Description
Peak serum level of CK, CK-MB, and cTnI
Timepoint
At 12 hours following operation in the ICU
Method of measurement
mcg/L
8
Description
The rate of superficial or deep wound infection
Timepoint
During hospitalization
Method of measurement
Number (percentage)
9
Description
The rate of re-exploration due to hemorrhage or tamponade
Timepoint
Within 24 hours following surgery in the ICU
Method of measurement
Number (percentage)
10
Description
Ventilation time
Timepoint
Within 24 hours following surgery in the ICU
Method of measurement
Hours
11
Description
Arterial level of base excess (BE)
Timepoint
Within one hour after arrival to ICU
Method of measurement
mmol/L
12
Description
Duration of ICU stay
Timepoint
following surgery
Method of measurement
Days
13
Description
Duration of hospital stay
Timepoint
following surgery
Method of measurement
Days
Intervention groups
1
Description
Intervention group: Mostly crystalloid cardioplegia (2% blood to prevent obscuring of the operative field), is infused continuously through vein grafts by a separate infusion set, once each distal anastomosis is completed at a rate of 10 to 20 mL per minute. This infusion is continued until half of the last distal anastomosis performed. The traditional method of intermittent cold blood (4 degrees Celsius) cardioplegia instillation, repeated every 20 minutes is implemented as well.
Category
Treatment - Surgery
2
Description
Control group: Antegrade cold blood cardioplegia (at a ratio of 4 to 1) is infused via aortic root by means of a cannula inserted by the surgeon at the middle part of ascending aorta. This injection conducting by the perfusionist, usually lasts about 3 minutes and should be repeated every 20 minutes (intermittent fashion).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr. Mehrzad Sharifi
Street address
Sardasht square. Arak. Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology, Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjmand zadegan
Street address
Vice chancellor for research and technology, Arak University of Medical Sciences, Basij square.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and technology, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehrzad Sharifi
Position
Assistant professor in cardiovascular surgery
Other areas of specialty/work
Street address
Cardiac surgery department, Amiralmomenin hospital, Sardasht square
City
Arak
Postal code
Phone
+98 86 3417 3602
Fax
Email
m.sharifi@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehrzad Sharifi
Position
Assistant professor in cardiovascular surgery
Other areas of specialty/work
Street address
Cardiac surgery department, Amiralmomenin hospital, Sardasht square
City
Arak
Postal code
Phone
+98 86 3417 3602
Fax
Email
m.sharifi@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehrzad Sharifi
Position
Assistant professor in cardiovascular surgery
Other areas of specialty/work
Street address
Cardiac surgery department, Amiralmomenin hospital, Sardasht square
City
Arak
Postal code
Phone
+98 86 3417 3602
Fax
Email
m.sharifi@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)