Placebo- Controlled,Randomized,Double Blind Trial of Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- Change in Interleukin 6(IL6)
Study Overview
Brief Summary
The aim of this trail is to assess the safety and therapeutic effects of single EPO intervention in different times during coronary surgery in changes of inflammatory response.
Detailed Description
In addition to well-known effect of Erythropoietin (EPO) on erythropoiesis in hypoxic conditions, some lines of evidence suggest its protective effects against reperfusion injury in several tissues by its specific receptor.
Preclinical studies have indicated a broad variety of cardioprotective actions for EPO. It improves cardiac function and exercise capacity in congestive heart failure, angiogenesis, limit myocardial inflammatory response, cardiac remodeling, infarct size and apoptosis extension induced by reperfusion injury. Activation of EPO receptor in endothelial and cardiac cells is suggested to attenuate proinflammatory cytokines production and inflammatory cells infiltration, and increasing nitric oxide production through possible mechanisms.
Reperfusion injury is unavoidable event during cardiac surgery using cardiopulmonary bypass.It is associated with inflammation, cell injury and attenuate contractility property.
Although it is an area of concern and many clinical studies have been designed by different interventions, it remains a major challenge. EPO intervention during heart reperfusion (surgery/ percutaneous angioplasty) as a new promise of cardioprotection strategy is the main design of several studies with conflicting results .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Revascularization requirement according to angiographic evidence
- •Elective coronary artery bypass graft surgery
- •First time coronary artery bypass graft surgery
- •On-pump coronary artery bypass graft surgery
Exclusion Criteria
- •History of myocardial infarction in the past 3 months
- •Previous myocardial trauma or major surgery in the past 3 months
- •Cr>2mg/dl
- •Receiving streptokinase or previous reperfusion treatments
- •Erythropoietin intake in the recent 6 months
- •Known thromboembolic disorder and malignant disease
- •Uncontrolled hypertension
- •Polycythemia
- •Previous valvular surgery
Arms & Interventions
group A
20000 IU erythropoietin infusion during aortic cross clamp in 45-60 minutes
Intervention: erythropoietin (Drug)
group B
20000 IU erythropoietin infusion after induction of anesthesia and before undergoing cardiopulmonary bypass pump in 45-60 minutes
Intervention: erythropoietin (Drug)
control
50 ml normal saline infusion during aortic cross clamp in 45-60 minutes
Intervention: normal saline (Drug)
Outcomes
Primary Outcomes
Change in Interleukin 6(IL6)
Time Frame: Change from baseline until 48 hours after surgery
Serum IL6(an inflammatory marker) level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation
Change in YKL-40
Time Frame: Change from baseline until 48 hours after surgery
Chitinase-3-like protein 1 (CHI3L1), also known as YKL-40 is an inflammatory marker.Serum YKL-40 level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation
Change in pro b-type natriuretic peptide(pro BNP)
Time Frame: Change from baseline until 48 hours after surgery
Serum pro BNP level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation
Secondary Outcomes
- Volume of bleeding(During operation until 24 hours after surgery)
- Need to blood transfusion(During and after operation, through study completion,an average of one week)
- Ventilation time(Period of time after surgery that patient has been intubated in ICU,an average of 10 hours)
Investigators
Mahnoosh Foroughi
Clinical Professor
Shahid Beheshti University of Medical Sciences