Trial · NCT04291508

Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery

NCT04291508, Phase 2, Completed, Massachusetts General Hospital; results first posted 2024-09-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery. Trials, record NCT04291508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04291508

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery
NCT number: NCT04291508
Status: Completed
Phases: Phase 2
Enrollment: 488 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Acute Respiratory Distress Syndrome, Critical Illness, Respiratory Failure, Sepsis
Interventions: Intravenous Acetaminophen (room temperature), Intravenous Vitamin C (refrigerated), 5% Dextrose (room temperature), 5% Dextrose refrigerated
First posted: 2020-03-02
Last updated: 2024-09-27
Results first posted: 2024-09-27

Source ClinicalTrials.gov

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Days Alive and Free of Organ Support to Day 28	28 days after randomization	Defined as the days alive and free of organ support (dialysis, assisted ventilation, and vasopressors) to day 28. Participants will need to be free of all three components (assisted ventilation, vasopressors, new renal replacement therapy) to qualify for a day alive and free from organ failures. Patients on chronic dialysis will not be scored for the new renal failure free component of this outcome.
Primary	28-day All Cause Mortality	28 days after randomization	Vital status at study day 28 regardless of location or cause of death. Patients discharged from the study hospital are followed to day 29 to determine this endpoint.
Primary	Days Free of Assisted Ventilation to Day 28	28 days after randomization	The number of days alive and without assisted ventilation (midnight to midnight) in the overall cohort. No penalty for death.
Primary	Days Free of Renal Replacement Therapy to Day 28 in Overall Cohort	28 days after randomization	The number of days alive and without renal replacement (RRT) in the overall cohort. If a participant was not on RRT at randomization, received RRT every other day, and stopped RRT before day 28, the number of renal replacement free days is the sum of the days free of RRT prior to dialysis starting and the number of days after dialysis stopped (begins with the first day, midnight to midnight, the participant was free of RRT). No penalty for death.
Primary	Days Free of Vasopressors to Day 28 in Overall Cohort	28 days after randomization	Days free of vasopressors to day 28 are defined as the number of calendar days (midnight to midnight) between randomization and 28 days later that the patient is alive and did not receive vasopressor therapy.
Secondary	Ventilator-free Days (VFD)	28 days after randomization	VFDs depend on both duration of ventilation and mortality through study day 28. In participants who survive 28 days, VFD is defined as 28 minus days of invasive or noninvasive ventilation to day 28. Duration of ventilation is counted from the first study day of assisted breathing through the last day of assisted breathing provided the last day is prior to day 28. Isolated periods of ventilation briefer than 24 hours for surgical procedures and ventilation solely for sleep disordered breathing do not count towards duration of ventilation. In participants who never require assisted breathing, duration of ventilation is zero. Participants who do not survive 28 days will be assigned zero VF
Secondary	Vasopressor-free Days	28 days after randomization	Vasopressor free days to day 28 are defined as the number of calendar days between randomization and 28 days later that the patient is alive and without the use of vasopressor therapy. Patients who die prior to day 28 and those who receive vasopressor therapy for the entire first 28 days are assigned zero vasopressor free days.
Secondary	Renal Replacement-free Days	28 days after randomization	Renal replacement free days to day 28 are defined as the number of calendar days between randomization and 28 days later that the patient is alive and without renal replacement therapy. We also follow the "last off" method. Patients who died prior to day 28 and those who receive renal replacement therapy for the entire first 28 days are assigned zero renal replacement free days.
Secondary	28 Day Hospital Mortality	28 days after randomization	All deaths occuring in the study hospital until study day 28.
Secondary	ICU Free Days	28 days after randomization	The number of days spent alive out of the ICU to day 28.

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes21

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Days Alive and Free of Organ Support to Day 28	28 days after randomization	Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm.	days	MEAN
PRIMARY	28-day All Cause Mortality	28 days after randomization	Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Days Free of Assisted Ventilation to Day 28	28 days after randomization	Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm.	days	MEAN
PRIMARY	Days Free of Renal Replacement Therapy to Day 28 in Overall Cohort	28 days after randomization	Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm.	days	MEAN
PRIMARY	Days Free of Vasopressors to Day 28 in Overall Cohort	28 days after randomization	Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm.	days	MEAN
SECONDARY	Ventilator-free Days (VFD)	28 days after randomization	Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm.	days	MEAN
SECONDARY	Vasopressor-free Days	28 days after randomization	Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm.	days	MEAN
SECONDARY	Renal Replacement-free Days	28 days after randomization	Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm.	days	MEAN
SECONDARY	28 Day Hospital Mortality	28 days after randomization	Data needed to determine this outcome was missing in 3 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	ICU Free Days	28 days after randomization	Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm.	days	MEAN

1 to 10 of 21Source ClinicalTrials.gov

See all 21 outcomes

Results by group84

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Days Alive and Free of Organ Support to Day 28	IV Acetaminophen-Active	20.2	Standard Deviation 10.6	days
Days Alive and Free of Organ Support to Day 28	IV Vitamin C-Active	20.5	Standard Deviation 9.5	days
Days Alive and Free of Organ Support to Day 28	Acetaminophen-Placebo	19.7	Standard Deviation 10.5	days
Days Alive and Free of Organ Support to Day 28	Vitamin C-Placebo	18.4	Standard Deviation 11.7	days
28-day All Cause Mortality	IV Acetaminophen-Active	39		Participants
28-day All Cause Mortality	IV Vitamin C-Active	6		Participants
28-day All Cause Mortality	Acetaminophen-Placebo	43		Participants
28-day All Cause Mortality	Vitamin C-Placebo	6		Participants
Days Free of Assisted Ventilation to Day 28	IV Acetaminophen-Active	21.5	Standard Deviation 10.2	days
Days Free of Assisted Ventilation to Day 28	IV Vitamin C-Active	21.6	Standard Deviation 9.4	days

1 to 10 of 84Source ClinicalTrials.gov

See all 84 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	IV Acetaminophen-Active	228
Overall Study	STARTED	IV Vitamin C-Active	40
Overall Study	STARTED	Acetaminophen-Placebo	199
Overall Study	STARTED	Vitamin C-Placebo	21
Overall Study	COMPLETED	IV Acetaminophen-Active	223
Overall Study	COMPLETED	IV Vitamin C-Active	40
Overall Study	COMPLETED	Acetaminophen-Placebo	197
Overall Study	COMPLETED	Vitamin C-Placebo	21
Overall Study	NOT COMPLETED	IV Acetaminophen-Active	5
Overall Study	NOT COMPLETED	IV Vitamin C-Active	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events272

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Acute Blood Loss Anemia	Blood and lymphatic system disorders	IV Acetaminophen-Active	1	227
other	Acute Blood Loss Anemia	Blood and lymphatic system disorders	IV Vitamin C-Active	0	40
other	Acute Blood Loss Anemia	Blood and lymphatic system disorders	Acetaminophen-Placebo	0	199
other	Acute Blood Loss Anemia	Blood and lymphatic system disorders	Vitamin C-Placebo	0	21
other	Paroxysmal Atrial Fibrillation	Cardiac disorders	IV Acetaminophen-Active	1	227
other	Paroxysmal Atrial Fibrillation	Cardiac disorders	IV Vitamin C-Active	0	40
other	Paroxysmal Atrial Fibrillation	Cardiac disorders	Acetaminophen-Placebo	0	199
other	Paroxysmal Atrial Fibrillation	Cardiac disorders	Vitamin C-Placebo	0	21
other	Diabetes Mellitus	Endocrine disorders	IV Acetaminophen-Active	1	227
other	Diabetes Mellitus	Endocrine disorders	IV Vitamin C-Active	0	40

1 to 10 of 272Source ClinicalTrials.gov

See all 272 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IV Acetaminophen-Active	58	223
Total, all-cause mortality	IV Vitamin C-Active	6	40
Total, all-cause mortality	Acetaminophen-Placebo	60	197
Total, all-cause mortality	Vitamin C-Placebo	9	21
Total, other adverse events	IV Acetaminophen-Active	12	227
Total, other adverse events	IV Vitamin C-Active	2	40
Total, other adverse events	Acetaminophen-Placebo	7	199
Total, other adverse events	Vitamin C-Placebo	2	21
Total, serious adverse events	IV Acetaminophen-Active	20	227
Total, serious adverse events	IV Vitamin C-Active	4	40

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38762798	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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