Effects of Pentoxifylline After Cardiac Surgery

nooshin dalili

Status: Completed

Conditions: AKI; Inflammation; Oxidative Stress

Treatments: Other: Pentoxifylline; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03591536

SBU13463

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

pentoxifylline oral

Other group

Description:

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

Treatment:

Other: Pentoxifylline

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo