Protocol summary

Summary
Homogeneous delivery of cardioplegia is an important component of myocardial protection in any patient who undergoes open heart surgery and poorly protected myocardial segments may have decreased function following ischemia. It has been shown that inhomogeneous cardioplegic delivery results in impaired regional and global left ventricular (LV) systolic function, as well as impaired diastolic function. Antegrade delivery of cardioplegia via the aortic root is a common cardioplegic delivery technique while it could result in an inhomogeneous perfusion of myocardium in some kind of cardiac surgery. Retrograde cardioplegia via the coronary sinus is another way of myocardial protection which may provide better protection of myocardium in such patients. Some studies have shown that warm antegrade cardioplegia results in better left ventricular perfusion than warm retrograde cardioplegia while some others are on this supposition that retrograde application of cardioplegia is more advantageous. Because of important affects of cardioplegia on patients outcome, a great need exists to find the differences between retrograde and anterograde cardioplegia with new methods. Therefore, we are on this supposition that measuring ischemic and inflammatory biomarkers in coronary sinus blood sample before, during, and after cardiopulmonary bypass would provide us with more valuable information. 100 patients from Dr.Ghavidel surgery service who meet the inclusion criteria at Rajaee heart center are included in this single blinded randomized clinical trial. All patients are first time candidates for cardiac surgery. They will be randomized into two equal groups with Random number table method of randomization. Procedure: Routin antrograde will be done in control group and routin anterograde-retrograde cardioplegia will be done in treatment group. Further details are mentioned below. Coronary Sinus Sampling: To determine the effects on myocardial stress, blood samples are taken from the retrograde coronary sinus catheter (before institution of CPB, On removal of aortic cross-clamp, 30 minutes after weaning from CPB) for interleukin (IL)-6, IL-18, and tumor necrosis factor (TNF)-alpha, Na, K, Ca, Lactate, pyruvate and LP (Lactate Pyruvate) ratio, cTnI, sICAM-1, sVCAM-1, Lactate dehydrogenase, high sensitivity C-reactive protein (hsCRP), PH, and HCO3 levels. Serum samples were also analyzed to measure these biomarkers as well (before institution of CPB, on removal of aortic cross-clamp, 30 minutes, and 12 hours after completion of CPB).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202048860N1
Registration date: 2013-07-16, 1392/04/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-07-16, 1392/04/25
Registrant information
Name
Alireza Alizadeh Ghavidel
Name of organization / entity
Rajaei Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2147
Email address
aghavidel@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Rajaie Cardiovascular Medical and Research Center
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation and comparison of Coronary sinus Inflammatory and ischemic biomarkers level in retrograde-anterograde versus anterograde cardioplegia during cardiopulmonary bypass surgery: A single blinded randomized controlled trial
Public title
The evaluation and comparison of Coronary sinus Inflammatory and ischemic biomarkers level in retrograde-anterograde versus anterograde cardioplegia during cardiopulmonary bypass surgery: A single blinded randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients undergoing cardiopulmonary bypass surgery at one operator service in our institution were prospectively screened for inclusion in the investigation. Consecutive patients with the following characteristics were selected for inclusion in the study: valvular with at least two vessels coronary disease. Exclusion criteria: total respiratory disability; renal failure (Cr > 2); age ≥ 80 years old; history of MI in 4 weeks preoperatively; failure to retrograde catheter insertion; where total respiratory disability is any of: height-corrected FEV1 (1.1-1.4) and DLCO less than 30 percent predicted (Technical revisions to medical criteria for determinations of disability).
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Junction of Shahid Hemmat and Shahid Chamran expressways
City
Tehran
Postal code
Approval date
2013-06-22, 1392/04/01
Ethics committee reference number
92-01-14-17083-86435

Health conditions studied

1

Description of health condition studied
Myocardial Infarction
ICD-10 code
121
ICD-10 code description
myocardial infarction specified as acute or with a stated duration of 4 weeks (28 days) or less from onset

Primary outcomes

1

Description
Mortality
Timepoint
30-day after surgery
Method of measurement
ID

Secondary outcomes

1

Description
blood level of IL18 in peripheral blood sample
Timepoint
before institution of CPB, on removal of aortic cross-clamp, 30 minutes, and 12 hours after completion of CPB
Method of measurement
Laboratory kit

2

Description
blood level of Na in peripheral blood sample
Timepoint
before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB
Method of measurement
Laboratory kit

3

Description
blood level of K in peripheral blood sample
Timepoint
before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB
Method of measurement
Laboratory kit

4

Description
blood level of Ca in peripheral blood sample
Timepoint
before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB
Method of measurement
Laboratory kit

5

Description
blood level of Lactate in peripheral blood sample
Timepoint
before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB
Method of measurement
Laboratory kit

6

Description
blood level of Lactate/Pyruvate in peripheral blood sample
Timepoint
before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB
Method of measurement
Laboratory kit

7

Description
blood level of HSCRP in peripheral blood sample
Timepoint
before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB
Method of measurement
Laboratory kit

8

Description
blood level of HCO3 in peripheral blood sample
Timepoint
before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB
Method of measurement
Laboratory kit

9

Description
blood level of PH in peripheral blood sample
Timepoint
before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB
Method of measurement
Laboratory kit

Intervention groups

1

Description
Control group: cold, Bloody cardioplegic solution (st. Thomas II based) is applied at an initial volume of 1000 mL in all patients. A second or third shot of 300 to 500 mL is given to patients with restarting electrical heart activity or after 20 minutes of cross-clamp time after the previous application
Category
Treatment - Surgery

2

Description
Intervention group: the initial dose delivered in the same route and the next cardiolpegia will be infused via retrograde catheter 200-300 ml after every distal anastomosis for CABG cases or 300-500 ml every 20 min in other procedures. Antegrade cardioplegia will be re-infused after 40 min for long-time cross clamping time
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaei Heart Center
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rajaie cardiovascular medical and research center
Full name of responsible person
Dr. Majid Haghjoo
Street address
Valiasr Ave. Nyayesh Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaie cardiovascular medical and research center
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
Rajaie heart center
Full name of responsible person
Dr. Alireza Alizadeh Ghavidel
Position
Associate Professor
Other areas of specialty/work
Street address
Valiasr Ave, Nyayesh Blvd
City
Tehran
Postal code
Phone
+98 21 2392 2147
Fax
Email
aghavidel@rhc.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rajaie Heart Center
Full name of responsible person
Dr. Alireza Alizadeh Ghavidel
Position
Associate Professor
Other areas of specialty/work
Street address
Valiasr Ave, Nyayesh Blvd.
City
Tehran
Postal code
Phone
+98 21 2392 2147
Fax
Email
aghavidel@rhc.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rajaei Heart Center
Full name of responsible person
Dr. Alireza Alizadeh Ghavidel
Position
Associate Professor
Other areas of specialty/work
Street address
Valiasr Ave, Nyayesh Blvd.
City
Tehran
Postal code
Phone
+98 21 2392 2147
Fax
Email
aghavidel@rhc.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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