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OpenTrials
Completed

NCT Number: NCT03591536

Effects of Pentoxifylline 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.

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Key information

Conditions

Oxidative Stress AKI Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pentoxifylline

Other

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

Other names: pentoxifylline tablets

Placebo

Other

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

Primary outcomes

  1. change of creatinine level before and after cardiac surgery

    Time frame: change of serum creatinine level 24 hours , 72 hours and 96 hours after cardiac surgery

    change of serum creatinine level post CABG between pentoxifylline and placebo arms

Secondary outcomes

  1. Oxidative stress

    Time frame: before and 24 hours after end of cardiac surgery

    change of serum malondialdehyde (MDA) level as the inflammatory marker before and 24 hours after cardiac surgery

  2. inflammatory status

    Time frame: before and 24 hours after end of cardiac surgery

    change of serum IL-6 , TNF( tumor necrosis factor) , IL-8 between two arms post cardiac surgery

  3. measuring change of (BMI) weight in kilogram and height in centimeters ratio

    Time frame: before and after end of cardiopulmonary bypass pomp

    using weight and height ratio for calculating BMI

Sponsors and collaborators

Lead sponsor

nooshin dalili

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 19, 2018
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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