Effects of Pentoxifylline After Cardiac Surgery

Study Overview
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Brief Summary
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Acute Kidney Injury (AKI) is a common and serious post operative complication and may occur in up to 50% of all patients undergoing cardiac surgery and is associated with 8% mortality rate compared with 0.9% in non-affected patients and remains a major factor for post surgery adverse outcomes. Early interventions to prevent postoperative AKI can help decreasing morbidity and mortality in these patients. Using cardiopulmonary bypass during cardiac surgery triggers systemic inflammatory response and recruits pro-inflammatory cytokines such as tumor necrosis factor, interleukin -10 (IL-10) and Interleukin-6 (IL-6) accompanying with production of free oxygen radicals which provokes oxidative stress in the milieu of ischemic reperfusion injury. Pentoxifylline as a non-specific phosphodiesterase inhibitor, can suppress the production of some factors of inflammatory response and oxidative stress, probably prevent post surgery AKI with these mechanisms.

Detailed Description
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This is a double blind randomized multicenter clinical trial, enrolling 100 consecutive patients undergoing elective Coronary Artery Bypass Graft Surgery (CABG). Patients randomly and within concealment method divided into two groups, one to receive oral pentoxifylline 400 mg every 8 hours from three days before surgery and the other group received placebo. All the intubation , surgery and weaning protocols were the same.

Official Title
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Effects of Pentoxifylline on Reducing Acute Kidney Injury , Inflammation and Oxidative Stress After Cardiac Surgery

Conditions
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Oxidative Stress, AKI, Inflammation

Intervention / Treatment
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* Other: Pentoxifylline
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The elective CABG candidate Exclusion Criteria: refusal to sign the consent, collagen vascular disease, use of immunosuppressive agents, corticosteroids (> 3 days), methylxanthines, diltiazem or sodium nitroprusside, angiography in the past 7 days, hemorrhagic diathesis and coagulopathy, uncontrolled diabetes mellitus sepsis renal failure (sCr > 2 mg/dl), hepatic failure (AST (Aspartate transaminase) or ALT(alanine transaminase) > 40 U/L) urinary tract infection.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind randomized clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pentoxifylline oral<br>50 adult patient underwent elective CABG intervention to be administered will be receiving main drug (pentoxifylline )oral 400 mg' every 8 hours from three days before surgery and on the day of surgery effect of intervention regarding antioxidant | Other: Pentoxifylline<br>* 400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery<br>* Other names: pentoxifylline tablets;|
| Placebo Comparator: placebo<br>50 adult patient underwent elective CABG received oral placebo pill resembling completely to pentoxifylline 400 mg, every 8 hours from three days before surgery and on the day of surgery | Other: Placebo<br>* oral placebo tablets from 3 days before surgery and on the day of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of creatinine level before and after cardiac surgery | change of serum creatinine level post CABG between pentoxifylline and placebo arms | change of serum creatinine level 24 hours , 72 hours and 96 hours after cardiac surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress | change of serum malondialdehyde (MDA) level as the inflammatory marker before and 24 hours after cardiac surgery | before and 24 hours after end of cardiac surgery | 
| inflammatory status | change of serum IL-6 , TNF( tumor necrosis factor) , IL-8 between two arms post cardiac surgery | before and 24 hours after end of cardiac surgery | 
| measuring change of (BMI) weight in kilogram and height in centimeters ratio | using weight and height ratio for calculating BMI | before and after end of cardiopulmonary bypass pomp |