Effects of Pentoxifylline After Cardiac Surgery

NCT ID: NCT03591536

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-05-01

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.

Conditions

Oxidative Stress; AKI; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

pentoxifylline oral

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

Group Type: OTHER

Pentoxifylline

Intervention Type: OTHER

400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery

placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

oral placebo tablets from 3 days before surgery and on the day of surgery

Interventions

Pentoxifylline

400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery

Intervention Type: OTHER

Placebo

oral placebo tablets from 3 days before surgery and on the day of surgery

Intervention Type: OTHER

Other Intervention Names

pentoxifylline tablets

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

nooshin dalili

OTHER

Sponsor Role: lead

Responsible Party

nooshin dalili

Assistant Professor of SBMU

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

SBU13463

Identifier Type: -

Identifier Source: org_study_id