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
About this trial
This is an interventional prevention trial for Oxidative Stress
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.
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
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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