Trial Outcomes & Findings for Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults (NCT NCT01869699)
NCT ID: NCT01869699
Last Updated: 2017-08-09
Results Overview
time-weighted average core body temperature over 4 hours. Core temperature was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the core temperature values was divided by time in minutes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
Baseline to 4 hours post study drug administration
Results posted on
2017-08-09
Participant Flow
Participant milestones
| Measure |
Normal Saline Placebo
Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes
|
Acetaminophen
Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Normal Saline Placebo
Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes
|
Acetaminophen
Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults
Baseline characteristics by cohort
| Measure |
Normal Saline Placebo
n=20 Participants
Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes
|
Acetaminophen
n=20 Participants
Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 13 • n=99 Participants
|
58 years
STANDARD_DEVIATION 15 • n=107 Participants
|
57.5 years
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
31 kilograms per meter squared
STANDARD_DEVIATION 7 • n=99 Participants
|
29 kilograms per meter squared
STANDARD_DEVIATION 5 • n=107 Participants
|
30 kilograms per meter squared
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Primary ICU diagnosis
Number of patients with Medical diagnoses
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Primary ICU diagnosis
Number of patients with Surgical diagnoses
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Primary ICU diagnosis
Number of patients iwth Neurologic diagnoses
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Acute Physiologic and Chronic Health Evaluation (APACHE) II score
|
24 scores on a scale
STANDARD_DEVIATION 6 • n=99 Participants
|
24 scores on a scale
STANDARD_DEVIATION 6 • n=107 Participants
|
24 scores on a scale
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Number of patients with infectious and noninfectious etiology of fever
Number of patients with Infectious etiology
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Number of patients with infectious and noninfectious etiology of fever
Number of patients with Noninfectious etiology
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Number of patients receiving types of medication infusions
Number of patients on vasopressor infusions
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Number of patients receiving types of medication infusions
Number of patients on vasodilator infusions
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Number of patients receiving types of medication infusions
Number of patients on sedative infusions
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Number of patients receiving types of medication infusions
Number of patients on analgesic infusions
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Number of patients receiving types of medication infusions
Number of patients on no medication infusions
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Number of patients with sepsis
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Number of patients receiving Mechanical Ventilation
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Mode of ventilation
Number of patients on Pressure Support
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Mode of ventilation
Number of patients on Assist Control
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Mode of ventilation
Number of patients NOT on mechanical ventilation
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Temperature of room
|
21.5 degrees Celsius
STANDARD_DEVIATION 1.4 • n=99 Participants
|
21.4 degrees Celsius
STANDARD_DEVIATION 1.2 • n=107 Participants
|
21.4 degrees Celsius
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Core body temperature
|
38.6 degrees Celsius
STANDARD_DEVIATION 0.5 • n=99 Participants
|
38.4 degrees Celsius
STANDARD_DEVIATION 0.3 • n=107 Participants
|
38.5 degrees Celsius
STANDARD_DEVIATION 0.4 • n=206 Participants
|
|
Heart Rate
|
93 beats per minute
STANDARD_DEVIATION 15 • n=99 Participants
|
90 beats per minute
STANDARD_DEVIATION 14 • n=107 Participants
|
91.5 beats per minute
STANDARD_DEVIATION 14.5 • n=206 Participants
|
|
systolic blood pressure
|
135 mm Hg
STANDARD_DEVIATION 26 • n=99 Participants
|
151 mm Hg
STANDARD_DEVIATION 26 • n=107 Participants
|
143 mm Hg
STANDARD_DEVIATION 26 • n=206 Participants
|
|
diastolic blood pressure
|
64 mm Hg
STANDARD_DEVIATION 13 • n=99 Participants
|
73 mm Hg
STANDARD_DEVIATION 15 • n=107 Participants
|
67.5 mm Hg
STANDARD_DEVIATION 14 • n=206 Participants
|
|
mean arterial pressure
|
89 mm Hg
STANDARD_DEVIATION 16 • n=99 Participants
|
100 mm Hg
STANDARD_DEVIATION 20 • n=107 Participants
|
94.5 mm Hg
STANDARD_DEVIATION 18 • n=206 Participants
|
|
respiratory rate
|
24 breaths per minute
STANDARD_DEVIATION 5 • n=99 Participants
|
20 breaths per minute
STANDARD_DEVIATION 6 • n=107 Participants
|
22 breaths per minute
STANDARD_DEVIATION 5.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 hours post study drug administrationPopulation: Patients in an ICU with fever, weighed \> 50kg and did not meet any exclusion criteria.
time-weighted average core body temperature over 4 hours. Core temperature was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the core temperature values was divided by time in minutes.
Outcome measures
| Measure |
Normal Saline Placebo
n=20 Participants
Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes
|
Acetaminophen
n=20 Participants
Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes
|
|---|---|---|
|
Core Body Temperature
|
38.4 degrees Celsius
Standard Error 0.1
|
37.9 degrees Celsius
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline to 4 hours post study drug administrationPopulation: Patients in the ICU with fever, weight of \> 50kg and no exclusion criteria met.
time-weighted average heart rate over 4 hours. Heart rate was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the heart rate values was divided by time in minutes.
Outcome measures
| Measure |
Normal Saline Placebo
n=20 Participants
Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes
|
Acetaminophen
n=20 Participants
Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes
|
|---|---|---|
|
Heart Rate
|
92 beats per minute
Standard Error 2
|
87 beats per minute
Standard Error 2
|
SECONDARY outcome
Timeframe: Baseline to 4 hours post study drug administrationtime-weighted average systolic blood pressure over 4 hours. Systolic blood pressure was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the systolic blood pressure values was divided by time in minutes.
Outcome measures
| Measure |
Normal Saline Placebo
n=20 Participants
Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes
|
Acetaminophen
n=20 Participants
Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes
|
|---|---|---|
|
Systolic Blood Pressure
|
143 mm Hg
Standard Error 3
|
127 mm Hg
Standard Error 3
|
SECONDARY outcome
Timeframe: Baseline to 4 hours post study drug administrationPopulation: Patients in the ICU with fever, weight of \> 50kg and no exclusion criteria met.
time weighted average for respiratory rate over 4 hours. Respiratory rate was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the respiratory rate values was divided by time in minutes.
Outcome measures
| Measure |
Normal Saline Placebo
n=20 Participants
Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes
|
Acetaminophen
n=20 Participants
Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes
|
|---|---|---|
|
Respiratory Rate
|
22 breaths per minute
Standard Error 1
|
21 breaths per minute
Standard Error 1
|
SECONDARY outcome
Timeframe: 2 hourschange over time core temperature after study drug administration (adjusted to baseline core temperature)
Outcome measures
| Measure |
Normal Saline Placebo
n=20 Participants
Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes
|
Acetaminophen
n=20 Participants
Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes
|
|---|---|---|
|
2-hour Change Over Time Core Temperature
|
-0.01 degrees Celsius
Standard Error 1.3
|
-0.8 degrees Celsius
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Baseline to 2 hours2-hour change over time SBP from study drug administration (means adjusted to baseline SBP)
Outcome measures
| Measure |
Normal Saline Placebo
n=20 Participants
Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes
|
Acetaminophen
n=20 Participants
Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes
|
|---|---|---|
|
2-hour Change Over Time Systolic Blood Pressure
|
-0.1 mm Hg
Standard Error 5
|
-24 mm Hg
Standard Error 5
|
SECONDARY outcome
Timeframe: Baseline to 2 hours2-hour change over time heart rate from time of study drug administration (means adjusted to baseline HR)
Outcome measures
| Measure |
Normal Saline Placebo
n=20 Participants
Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes
|
Acetaminophen
n=20 Participants
Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes
|
|---|---|---|
|
2-hour Change Over Time Heart Rate
|
2 BPM
Standard Error 2
|
-6 BPM
Standard Error 2
|
Adverse Events
Normal Saline Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Hildy Schell-Chaple
University of California, San Francisco
Phone: 415-353-1039
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place