Effects of Pentoxifylline After Cardiac Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; AKI; Oxidative Stress
• Intervention / Treatment: Other: Pentoxifylline; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: Pentoxifylline; 400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery; Other Names: pentoxifylline tablets
Placebo Comparator: 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	Other: Placebo; oral placebo tablets from 3 days before surgery and on the day of surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: nooshin dalili

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: July 7, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 7, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Pentoxifylline
• Other Study ID Numbers: SBU13463

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No