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Inhibition of Lipid Peroxidation During Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01366976
Recruitment Status : Completed
First Posted : June 6, 2011
Results First Posted : January 14, 2015
Last Update Posted : January 27, 2015
Information provided by (Responsible Party):

June 2, 2011
June 6, 2011
January 6, 2015
January 14, 2015
January 27, 2015
July 2011
June 2013   (Final data collection date for primary outcome measure)
  • Plasma Isofuran Concentrations [ Time Frame: 24 hours ]
    Plasma isofuran concentrations as a measure of lipid peroxidation
  • Plasma F2-isoprostane Concentrations [ Time Frame: 24 hours ]
    Plasma F2-isoprostane concentrations as a measure of lipid peroxidation
Oxidative stress response [ Time Frame: 6 time points over 24 hours ]
Oxidative stress respsonse in both urine and plasma as measured by F2isoP and isoF concentrations
Complete list of historical versions of study NCT01366976 on ClinicalTrials.gov Archive Site
  • Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin) [ Time Frame: 24 hours ]
    Changes in urinary NGAL (neutrophil gelatinase-associated lipocalin) as marker of acute kidney injury
  • Serum Creatinine [ Time Frame: 72 hours ]
    Serum creatinine measured over a 72 hour period
Acute kidney injury [ Time Frame: 4 time points over 48 hours ]
Changes in creatinine and NGAL
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Inhibition of Lipid Peroxidation During Cardiac Surgery
Inhibition of Lipid Peroxidation During Cardiopulmonary Bypass
Acute kidney injury is a major complication of cardiac surgery requiring cardiopulmonary bypass (CPB). Hemolysis and rhabdomyolysis frequently occur during CPB. Hemolysis leads to an increase in free hemoglobin, whereas rhabdomyolysis leads to an increase in myoglobin. Free plasma hemoglobin and myoglobin have been shown to be independent predictors of the acute kidney injury that results from CPB. When these hemeproteins are released into the plasma, they undergo redox cycling, generating radical species that initiate lipid peroxidation and a cascade of oxidative damage to cellular membranes, notably in the kidney. F2-isoprostanes and isofurans are sensitive and specific markers of oxidative stress in vivo, and are increased after CPB, particularly in those patients with acute kidney injury. Acetaminophen inhibits the lipid peroxidation catalyzed by myoglobin and hemoglobin. Moreover, in an animal model of rhabdomyolysis-induced kidney injury, acetaminophen significantly attenuated the decrease in creatinine clearance compared to control. The current proposal tests the central hypothesis that acetaminophen will attenuate the lipid peroxidation associated with the hemolysis and rhabdomyolysis that occur in patients undergoing CPB. Demonstration that acetaminophen inhibits the lipid peroxidation resulting from CPB would provide a rationale for a prospective randomized trial to test the hypothesis that acetaminophen will reduce the acute kidney injury that results from CPB.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cardiopulmonary Bypass Induced Lipid Peroxidation
Drug: Acetaminophen
Acetaminophen 1g every 6 hours for 4 doses over 24 hours
Other Name: Tylenol
  • Placebo Comparator: Placebo
    Intervention: Drug: Acetaminophen
  • Active Comparator: Acetaminophen
    Acetaminophen will ge given as 1g every 6 hours for 4 doses over a 24 hours study period
    Intervention: Drug: Acetaminophen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects, 18 to 80 years of age, scheduled for elective cardiac surgery requiring CPB
  2. For female subjects, the following conditions must be met:

postmenopausal for at least 1 year, or status-post surgical sterilization, or if of childbearing potential, utilizing adequate birth control and a negative urine beta-hcg prior to drug treatment

Exclusion Criteria:

  1. Allergic reaction to ApAP (acetaminophen)
  2. Evidence of severe hepatic impairment (history of liver cirrhosis or total bilirubin >2.0mg/dl)
  3. Impaired renal function (serum creatinine >2.0 mg/dl)
  4. Emergency surgery
  5. Pregnancy
  6. Breast-feeding
  7. Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
  8. History of alcohol or drug abuse
  9. Treatment with any investigational drug in the 1 month preceding the study
  10. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
  11. Inability to comply with the protocol, e.g. uncooperative attitude and unlikelihood of completing the study
  12. History or evidence of active asthma
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Mias Pretorius, Vanderbilt University
Vanderbilt University
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Principal Investigator: Mias Pretorius, MBChB, MSCI Vanderbilt University
Vanderbilt University
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP