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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pentoxifylline oral | Other | 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 |
|
| placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline | Other | 400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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no plan
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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double blind randomized clinical trial
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only principle investigator knew the drug from placebo
| Placebo | Other | oral placebo tablets from 3 days before surgery and on the day of surgery |
|
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 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |