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Investigation of the changes in cardiac muscle damage marker and serum lactate in pateints undergoing cardiopumonary bypass using the del Nido cardioplegia versus Custodiol: A pilot study

Protocol summary

Summary
-Objective: to compare cardiac muscle damage marker and serum lactate levels in patients undergoing cardiopumonary bypass using the del Nido cardioplegia versus Custodiol. Study design: randomized, double-blinded, no use of placebo, single-center. Blinding will be done on patients and outcome assessors (nurses registering the clinical outcomes and laboratory personnel). -Population: -Inclusion criteria: patients undergoing coronary artery bypass and valve graft surgery, informed consent. -Exclusion criteria: diagnosed with inflammatory diseases before surgery, acute myocardial infarction, patient dissatisfaction in any part of the study, dialysis-requiring renal failure, ejection fraction less than 15%, second surgery, emergency patients, predictive pulmonary disease patients, cardiomyopathy patients. -Target sample size: 40 patients -Interventions: del Nido cardioplegia, Custodiol cardioplegia -Interventions time point: During cardiopumonary bypass -Primary outcome measures: Serum lactate, Cardiac Troponin I

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017083035991N1
Registration date: 2017-10-25, 1396/08/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-25, 1396/08/03
Registrant information
Name
Mehdi Dehghan Firoozabadi
Name of organization / entity
Tehran Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9256
Email address
mdfiroozabad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the changes in cardiac muscle damage marker and serum lactate in pateints undergoing cardiopumonary bypass using the del Nido cardioplegia versus Custodiol: A pilot study
Public title
A comparison of two methods to prevent cardiac muscle damage during cardiopulmonary bypass surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients undegoing coronary artery bypass and valve graft surgery, informed satisfaction. Exclusion criteria: diagnosed inflammatory diseases before surgery, acute myocardial infarction, patient dissatisfaction, dialysis-requiring renal failure, ejection fraction less than 15%, second surgery, emergency patients, predictive pulmonary disease patients, cardiomyopathy patients.
Age
To 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Blinding will be done on patients and outcome assessors (nurses registering the clinical outcomes and laboratory personnel). They will be unaware of the patients' allocation sequence.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
16 Azar St, Enghelab Sq, Tehran Province
City
Tehran
Postal code
Approval date
2017-09-17, 1396/06/26
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.3509

Health conditions studied

1

Description of health condition studied
Coronary artery bypass graft surgery
ICD-10 code
T82.9
ICD-10 code description
Unspecified complication of cardiac and vascular prosthetic device, implant and graft

Primary outcomes

1

Description
Cardiac Troponin I
Timepoint
Before operation, after operation and 24 hours after operation
Method of measurement
ng/ml using enzyme immunoassay

2

Description
Serum Lactate
Timepoint
Prior to the Coronary artery bypass graft surgery, Immediate post aortic declamping, At the entrance to the ICU, 6, 12, and 24 hours post entrance to the ICU
Method of measurement
Biochemical analyzer

Secondary outcomes

1

Description
Hemoglobin
Timepoint
Before operation, after operation and 24 hours after operation
Method of measurement
Hematology analyzer

2

Description
Hematocrit
Timepoint
Before operation, after operation and 24 hours after operation
Method of measurement
Hematology analyzer

3

Description
Platelet count
Timepoint
Before operation, after operation and 24 hours after operation
Method of measurement
Hematology analyzer

Intervention groups

1

Description
del Nido cardioplegia
Category
Treatment - Surgery

2

Description
Custodial cardioplegia
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Dr Mehdi Dehghan Firoozabadi
Street address
Surgery Department, Thran Heart Center, Nort Kargar St Thran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Qods St. Cross., Keshavars Blvd.
City
Thran
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, Tehran 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
Tehran Heart Center
Full name of responsible person
Mohammad Javad Mehranbaniyan
Position
Anesthesiologist
Other areas of specialty/work
Street address
Surgery Department, Thran Heart Center, Nort Kargar St
City
Tehran
Postal code
Phone
+218 8029203
Fax
Email
mehrabanian56@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Mehdi Dehghani Firoozabadi
Position
Associate Professor
Other areas of specialty/work
Street address
Surgery Department, Thran Heart Center, Nort Kargar St
City
Tehran
Postal code
Phone
+218 8029203
Fax
Email
mdfiroozabadi834@yahoo.commdfiroozabad@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Mohammad Javad Mehranbaniyan
Position
Anesthesiologist
Other areas of specialty/work
Street address
Surgery Department, Thran Heart Center, Nort Kargar St
City
Tehran
Postal code
Phone
+218 8029203
Fax
Email
mehrabanian56@gmail.com
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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