Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 68 of 1879 for:    ACETAMINOPHEN

Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis (ACROSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01739361
Recruitment Status : Completed
First Posted : December 3, 2012
Results First Posted : March 23, 2015
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
David Janz, Vanderbilt University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Severe Sepsis
Interventions Drug: Acetaminophen
Drug: placebo
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description

Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.

Acetaminophen

Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.

placebo

Period Title: Overall Study
Started 21 23
Completed 18 22
Not Completed 3 1
Arm/Group Title Acetaminophen Placebo Total
Hide Arm/Group Description

Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.

Acetaminophen

Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.

placebo

Total of all reporting groups
Overall Number of Baseline Participants 18 22 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 18 participants 22 participants 40 participants
50
(41 to 64)
58.5
(47.5 to 63.5)
55.5
(44 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 22 participants 40 participants
Female
9
  50.0%
10
  45.5%
19
  47.5%
Male
9
  50.0%
12
  54.5%
21
  52.5%
1.Primary Outcome
Title F2-isoprostanes After 72 Hours of Acetaminophen or Placebo
Hide Description F2-isoprostanes are a marker of oxidative stress, specifically lipid peroxidation.
Time Frame 72 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:

Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.

Acetaminophen

Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.

placebo

Overall Number of Participants Analyzed 18 22
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
33.4
(24.97 to 43.47)
40.15
(29.67 to 61.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.353
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title In-hospital Mortality
Hide Description percent of patients who died in the hospital
Time Frame Patients will be followed through the end of their hospital stay, an average of 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:

Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.

Acetaminophen

Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.

placebo

Overall Number of Participants Analyzed 18 22
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
4
  18.2%
3.Secondary Outcome
Title Serum Creatinine After 72 Hours of Treatment With Acetaminophen or Placebo
Hide Description serum creatinine measurements at 72 hours
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:

Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.

Acetaminophen

Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.

placebo

Overall Number of Participants Analyzed 18 22
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
1.04
(.61 to 1.44)
1.36
(.83 to 2.02)
Time Frame Participants were followed for the duration of hospital stay, an average of 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description

Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.

Acetaminophen

Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.

placebo

All-Cause Mortality
Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/21 (9.52%)   1/23 (4.35%) 
Hepatobiliary disorders     
AST or ALT >400 U/L *  2/21 (9.52%)  1/23 (4.35%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/23 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. David R Janz, MD, MSc, Assistant Professor of Medicine
Organization: LSU Health Sciences Center New Orleans
Phone: 504-568-3167
EMail: djanz@lsuhsc.edu
Layout table for additonal information
Responsible Party: David Janz, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01739361     History of Changes
Other Study ID Numbers: APAP-121486
First Submitted: November 26, 2012
First Posted: December 3, 2012
Results First Submitted: March 11, 2015
Results First Posted: March 23, 2015
Last Update Posted: December 26, 2017