Clinical trial NCT03591536: Effects of Pentoxifylline After Cardiac Surgery
Official title: Effects of Pentoxifylline on Reducing Acute Kidney Injury , Inflammation and Oxidative Stress After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
AKI
Inflammation
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized clinical trial
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: change of creatinine level before and after cardiac surgery
timeFrame: change of serum creatinine level 24 hours , 72 hours and 96 hours after cardiac surgery
Secondary outcomes:
measure: Oxidative stress
timeFrame: before and 24 hours after end of cardiac surgery
measure: inflammatory status
timeFrame: before and 24 hours after end of cardiac surgery
measure: measuring change of (BMI) weight in kilogram and height in centimeters ratio
timeFrame: before and after end of cardiopulmonary bypass pomp
Other outcomes:
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