Protocol summary

Summary
Coronary artery disease is the first cause of death in developed and underdeveloped countries around the world. Although new drugs and advanced percutanoeus techniques are of specific importance in late stages of the disease, but CABG has its specific role in management of patients. Nowadays, patients who are reffered for surgery are in more advanced stages of disease and the quality of coronary vessels is poorer. Pentoxifilline is a known drug that makes flexibility of RBCs better in microvasculature and reduces inflammatory response to CPB. In this research, we used oral pentoxifilline for patients who are candidate for CABG alone and have poor LV function (LVEF≤30%). 178 patients were devided in two groups equally (each group = 89). The drug was taken to group 1 (case) in order of 400 mg PO TDS for 3 days before operation. The control group had only routine drugs of ward. Patients with previous MI (during last 4 weeks), previous renal failure, uncontrolled diabetes and history of anti-inflamatory drug use were excluded. Samples of blood were taken before and after operation. Multiple laboratory and clinical markers including TNF-α, IL-6, Tropnin T, need for IABP, Inotropes, transfusion, Post-op CVA, post-op RF, ventilation dependency, ICU stay and death were checked.

General information

Acronym
Pre-CABG orally Pentoxiphylline effect on EF
IRCT registration information
IRCT registration number: IRCT201107197060N1
Registration date: 2013-05-19, 1392/02/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-05-19, 1392/02/29
Registrant information
Name
Soheil Mansourian
Name of organization / entity
Tehran heart center
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9600
Email address
k-abbasi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Heart Center - Department of Clinical Research
Expected recruitment start date
2011-09-08, 1390/06/17
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preoperative oral Pentoxifylline in case of CABG with severe LV dysfunction (EF≤30%) and their complications
Public title
Preoperative oral Pentoxifylline in case of CABG with severe LV dysfunction (EF≤30%) and their complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were isolated CABG using cardiopulmonary bypass pump (CPB) adult candidates with low ejection fraction (EF ≤ 30%). Exclusion criteria: previous renal failure (RF); recent myocardial infarction (MI) (less than 4 weeks ago); uncontrolled diabetes and use of anti-inflammatory drugs.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 178
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
Poursina Street
City
Tehran
Postal code
1411713138
Approval date
2011-04-09, 1390/01/20
Ethics committee reference number
2579/130/د/90

Health conditions studied

1

Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25
ICD-10 code description
Chronic ischaemic heart disease

Primary outcomes

1

Description
Ejection Fraction
Timepoint
pre and early post-operation
Method of measurement
echocardiography

Secondary outcomes

1

Description
Mortality
Timepoint
Early Post-Operation
Method of measurement
Clinical

Intervention groups

1

Description
In control group: only routine drugs.
Category
Treatment - Drugs

2

Description
In intervention group: Pentoxifilline 400 mg oral tablet, TDS, 3 days beside the routine drugs.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Dr Soheil Mansourian
Street address
North Kargar Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Somaye Kalaee
Street address
North Kargar Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Heart 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
Tehran Heart Center
Full name of responsible person
Soheil Mansourian
Position
Cardiac Surgery Student/ General Surgeon
Other areas of specialty/work
Street address
North Kagar Street
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9731
Email
soheilmansourian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Kyomars Abbasi
Position
Cardiac Surgeon
Other areas of specialty/work
Street address
North Kargar Street
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9731
Email
k-abbasi@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
Soheil Mansourian
Position
Cardiac Surgery Student
Other areas of specialty/work
Street address
North Kargar Street
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9731
Email
soheilmansourian@yahoo.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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