An interventional study of Pentoxifylline and Placebo in Oxidative Stress, AKI and Inflammation, sponsored by nooshin dalili. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-19.
Sponsored by nooshin dalili · Not applicable, Interventional, and Prevention
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.
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 100 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.
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Exclusion Criteria:
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
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
400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery
Also known as: pentoxifylline tablets
oral placebo tablets from 3 days before surgery and on the day of surgery
change of creatinine level before and after cardiac surgery
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
Oxidative stress
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
inflammatory status
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
measuring change of (BMI) weight in kilogram and height in centimeters ratio
using weight and height ratio for calculating BMI
Time frame: before and after end of cardiopulmonary bypass pomp
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Plan to share: No — no plan
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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