AKI, Inflammation, Oxidative Stress
Conditions
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.
Interventions
OTHERPentoxifylline
400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery
OTHERPlacebo
oral placebo tablets from 3 days before surgery and on the day of surgery
Sponsors
nooshin dalili
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
only principle investigator knew the drug from placebo
Intervention model description
double blind randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Outcome results
None listed