Trial Outcomes & Findings for Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis (NCT NCT01739361)

NCT ID: NCT01739361

Last Updated: 2017-12-26

Results Overview

F2-isoprostanes are a marker of oxidative stress, specifically lipid peroxidation.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 44 participants
• Primary outcome timeframe: 72 hours after randomization
• Results posted on: 2017-12-26

Participant Flow

Participant milestones

Measure	Acetaminophen 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	Placebo Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours. placebo
Overall Study STARTED	21	23
Overall Study COMPLETED	18	22
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis

Baseline characteristics by cohort

Measure	Acetaminophen n=18 Participants 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	Placebo n=22 Participants Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours. placebo	Total n=40 Participants Total of all reporting groups
Age, Continuous	50 years n=5 Participants	58.5 years n=7 Participants	55.5 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours after randomization

F2-isoprostanes are a marker of oxidative stress, specifically lipid peroxidation.

Outcome measures

Measure	Acetaminophen n=18 Participants 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	Placebo n=22 Participants Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours. placebo
F2-isoprostanes After 72 Hours of Acetaminophen or Placebo	33.4 pg/mL Interval 24.97 to 43.47	40.15 pg/mL Interval 29.67 to 61.8

SECONDARY outcome

Timeframe: Patients will be followed through the end of their hospital stay, an average of 5 weeks

percent of patients who died in the hospital

Outcome measures

Measure	Acetaminophen n=18 Participants 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	Placebo n=22 Participants Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours. placebo
In-hospital Mortality	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 72 hours

serum creatinine measurements at 72 hours

Outcome measures

Measure	Acetaminophen n=18 Participants 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	Placebo n=22 Participants Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours. placebo
Serum Creatinine After 72 Hours of Treatment With Acetaminophen or Placebo	1.04 mg/dL Interval 0.61 to 1.44	1.36 mg/dL Interval 0.83 to 2.02

Adverse Events

Acetaminophen

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Acetaminophen n=21 participants at risk 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	Placebo n=23 participants at risk Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours. placebo
Hepatobiliary disorders AST or ALT >400 U/L	9.5% 2/21 • Participants were followed for the duration of hospital stay, an average of 4 weeks	4.3% 1/23 • Participants were followed for the duration of hospital stay, an average of 4 weeks

Other adverse events

Adverse event data not reported

Additional Information

Dr. David R Janz, MD, MSc, Assistant Professor of Medicine

LSU Health Sciences Center New Orleans

Phone: 504-568-3167

Email: djanz@lsuhsc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place