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Effects of Pentoxifylline After Cardiac Surgery

Primary Purpose

Oxidative Stress, AKI, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pentoxifylline
Placebo
Sponsored by
nooshin dalili
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oxidative Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Placebo Comparator

    Arm Label

    pentoxifylline oral

    placebo

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    change of creatinine level before and after cardiac surgery
    change of serum creatinine level post CABG between pentoxifylline and placebo arms

    Secondary Outcome Measures

    Oxidative stress
    change of serum malondialdehyde (MDA) level as the inflammatory marker before and 24 hours after cardiac surgery
    inflammatory status
    change of serum IL-6 , TNF( tumor necrosis factor) , IL-8 between two arms post cardiac surgery
    measuring change of (BMI) weight in kilogram and height in centimeters ratio
    using weight and height ratio for calculating BMI

    Full Information

    First Posted
    May 23, 2018
    Last Updated
    July 7, 2018
    Sponsor
    nooshin dalili
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03591536
    Brief Title
    Effects of Pentoxifylline After Cardiac Surgery
    Official Title
    Effects of Pentoxifylline on Reducing Acute Kidney Injury , Inflammation and Oxidative Stress After Cardiac Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    June 1, 2017 (Actual)
    Study Completion Date
    May 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    nooshin dalili

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oxidative Stress, AKI, Inflammation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    double blind randomized clinical trial
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    only principle investigator knew the drug from placebo
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pentoxifylline oral
    Arm Type
    Other
    Arm 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
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm 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
    Intervention Type
    Other
    Intervention Name(s)
    Pentoxifylline
    Other Intervention Name(s)
    pentoxifylline tablets
    Intervention Description
    400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    oral placebo tablets from 3 days before surgery and on the day of surgery
    Primary Outcome Measure Information:
    Title
    change of creatinine level before and after cardiac surgery
    Description
    change of serum creatinine level post CABG between pentoxifylline and placebo arms
    Time Frame
    change of serum creatinine level 24 hours , 72 hours and 96 hours after cardiac surgery
    Secondary Outcome Measure Information:
    Title
    Oxidative stress
    Description
    change of serum malondialdehyde (MDA) level as the inflammatory marker before and 24 hours after cardiac surgery
    Time Frame
    before and 24 hours after end of cardiac surgery
    Title
    inflammatory status
    Description
    change of serum IL-6 , TNF( tumor necrosis factor) , IL-8 between two arms post cardiac surgery
    Time Frame
    before and 24 hours after end of cardiac surgery
    Title
    measuring change of (BMI) weight in kilogram and height in centimeters ratio
    Description
    using weight and height ratio for calculating BMI
    Time Frame
    before and after end of cardiopulmonary bypass pomp

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    no plan

    Learn more about this trial

    Effects of Pentoxifylline After Cardiac Surgery

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