Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Inhibition of Lipid Peroxidation During Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mias Pretorius, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01366976
First received: June 2, 2011
Last updated: January 14, 2015
Last verified: January 2015
Results First Received: January 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cardiopulmonary Bypass Induced Lipid Peroxidation
Intervention: Drug: Acetaminophen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled by the research nurse at the time of the preoperative evaluation for surgery. The study period was from January 2012 until April 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded for the following reasons: 1) allergy to acetaminophen, 2) evidence of severe hepatic impairment (history of liver cirrhosis or total bilirubin >2.0mg/dL) 3) evidence of impaired renal function (serum creatinine >2.0mg/dL) or 4) pregnancy.

Reporting Groups
  Description
Acetaminophen IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
Placebo Saline in equivalent volume as study drug

Participant Flow:   Overall Study
    Acetaminophen     Placebo  
STARTED     30     30  
COMPLETED     30     30  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients were eligible for the study if he/she was 18-80 years of age and undergoing elective cardiac surgery requiring cardiopulmonary bypass.

Reporting Groups
  Description
Acetaminophen IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
Placebo Saline in equivalent volume as study drug
Total Total of all reporting groups

Baseline Measures
    Acetaminophen     Placebo     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: years]
Median ( Inter-Quartile Range )
  64.5  
  ( 49 to 68.4 )  
  61.0  
  ( 54 to 67.8 )  
  63  
  ( 51.75 to 67.75 )  
Gender  
[units: participants]
     
Female     10     14     24  
Male     20     16     36  
Region of Enrollment  
[units: participants]
     
United States     30     30     60  



  Outcome Measures
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1.  Primary:   Plasma Isofuran Concentrations   [ Time Frame: 24 hours ]

2.  Primary:   Plasma F2-isoprostane Concentrations   [ Time Frame: 24 hours ]

3.  Secondary:   Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)   [ Time Frame: 24 hours ]

4.  Secondary:   Serum Creatinine   [ Time Frame: 72 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The exploratory analysis of acute kidney injury (AKI) was limited by the low incidence of postoperative AKI in the current study, so we were underpowered to detect small differences in creatinine or NGAL concentrations.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mias Pretorius
Organization: Vanderbilt University School of Medicine
phone: 16153220758
e-mail: mias.pretorius@vanderbilt.edu


Publications:

Responsible Party: Mias Pretorius, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01366976     History of Changes
Other Study ID Numbers: 110423
Study First Received: June 2, 2011
Results First Received: January 6, 2015
Last Updated: January 14, 2015
Health Authority: United States: Institutional Review Board