Effects of Pentoxifylline After Cardiac Surgery

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591536
• Other study ID #: SBU13463
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: July 2018
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 1, 2018
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AKI
• Inflammation
• Oxidative Stress

Intervention

Other:
• Pentoxifylline
400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery
• Placebo
oral placebo tablets from 3 days before surgery and on the day of surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
nooshin dalili

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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