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Effects of Pentoxifylline After Cardiac Surgery

Sponsor
nooshin dalili (Other)
Overall Status
Completed
CT.gov ID
NCT03591536
Collaborator
(none)
100
Enrollment
2
Arms
15.9
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pentoxifylline
  • Other: Placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
double blind randomized clinical trialdouble blind randomized clinical trial
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
only principle investigator knew the drug from placebo
Primary Purpose:
Prevention
Official Title:
Effects of Pentoxifylline on Reducing Acute Kidney Injury , Inflammation and Oxidative Stress After Cardiac Surgery
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. change of creatinine level before and after cardiac surgery [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 Outcome Measures

    1. Oxidative stress [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 [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 [before and after end of cardiopulmonary bypass pomp]

      using weight and height ratio for calculating BMI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • nooshin dalili

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    nooshin dalili, Assistant Professor of SBMU, Shahid Beheshti University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT03591536
    Other Study ID Numbers:
    • SBU13463
    First Posted:
    Jul 19, 2018
    Last Update Posted:
    Jul 19, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Inflammation
    Pentoxifylline

    Study Results

    No Results Posted as of Jul 19, 2018