Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery

PHASE2CompletedINTERVENTIONAL
Enrollment

488

Participants

Timeline

Start Date

October 13, 2021

Primary Completion Date

April 27, 2023

Study Completion Date

July 27, 2023

Conditions
Acute Respiratory Distress SyndromeCritical IllnessRespiratory FailureSepsis
Interventions
DRUG

Intravenous Acetaminophen (room temperature)

Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs \< 50 kg) every six hours for 5 days (20 doses)

DRUG

Intravenous Vitamin C (refrigerated)

Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses)

DRUG

5% Dextrose (room temperature)

Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses)

DRUG

5% Dextrose refrigerated

Placebo (identical appearing refrigerated 5% dextrose solution) infused every six hours for 5 days (20 doses)

Trial Locations (41)

10029

Mt. Sinai Hospital, New York

10461

Montefiore Medical Center-Weiler, The Bronx

10467

Montefiore Medical Center-Moses, The Bronx

15261

UPMC Presbyterian/Mercy/Shadyside/Magee, Pittsburgh

19140

Temple University Hospital, Philadelphia

22903

University of Virginia Health System, Charlottesville

23298

VCU Medical Center, Richmond

23507

Sentara/EVMS, Norfolk

27157

Wake Forest Baptist Medical Center, Winston-Salem

28204

Carolinas Medical Center, Charlotte

29425

Medical University of South Carolina, Charleston

35249

University of Alabama Medical Center, Birmingham

37221

Vanderbilt University Medical Center, Nashville

39216

University of Mississippi Medical Center, Jackson

43210

Ohio State University Wexner Medical Center, Columbus

44195

Cleveland Clinic Foundation, Cleveland

45219

University of Cincinnati Medical Center, Cincinnati

48025

Henry Ford Medical Center, Detroit

48109

University of Michigan Medical Center, Ann Arbor

55415

Hennepin County Medical Center, Minneapolis

55435

Fairview Southdale Hospital, Edina

70112

University Medical Center, New Orleans

77030

University of Texas Health Science Center, Houston

80045

University of Colorado Hospital, Aurora

80204

Denver Health Medical Center, Denver

84107

Intermountain Medical Center, Murray

84132

University of Utah Hospital, Salt Lake City

85721

University of Arizona, Tucson

90048

Cedars-Sinai Medical Center, Los Angeles

90095

Ronald Reagan UCLA Medical Center, Los Angeles

93701

UCSF Fresno, Fresno

94143

UCSF Medical Center, San Francisco

94305

Stanford University, Stanford

95817

UC Davis Medical Center, Sacramento

97239

Oregon Health and Science University, Portland

98104

Harborview Medical Center, Seattle

98122

Swedish Hospital First Hill, Seattle

04102

Maine Medical Center, Portland

02114

Massachusetts General Hospital, Boston

02115

Beth Israel Deaconess Medical Center, Boston

01199

Baystate Medical Center, Springfield

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER

NCT04291508 - Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery | Biotech Hunter | Biotech Hunter