Vitamin C, Thiamine, and Steroids in Sepsis

PHASE3CompletedINTERVENTIONAL
Enrollment

501

Participants

Timeline

Start Date

August 22, 2018

Primary Completion Date

August 22, 2019

Study Completion Date

January 29, 2020

Conditions
Sepsis
Interventions
DRUG

Vitamin C

Intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.

DRUG

Thiamine

Intravenous thiamine (100 mg every 6 hours) will be administered for 4 days or until ICU discharge.

DRUG

Hydrocortisone

Intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge.

DRUG

Vitamin C Placebo

A placebo to match intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.

DRUG

Thiamine Placebo

A placebo to match intravenous thiamine (100 mg every 6 hours) will be administered for 4 days or until ICU discharge.

DRUG

Hydrocortisone Placebo

A placebo to match intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge. Steroids will be used when clinically indicated.

Trial Locations (43)

10065

Memorial Sloan Kettering Cancer Center, New York

10461

Montefiore Medical Center Weiler, The Bronx

10467

Montefiore Medical Center Moses, The Bronx

19104

University of Pennsylvania Health System Hospital, Philadelphia

19107

Medical University of South Carolina, Charleston

19140

University of Colorado Denver, Denver

19718

Christiana Care, Newark

20010

Medstar Washington Hospital Center, Washington D.C.

21201

Stanford University, Stanford

21224

Johns Hopkins Bayview, Baltimore

Thomas Jefferson University, Philadelphia

21287

Johns Hopkins Hospital, Baltimore

23114

University of Cincinnati Physicians Company, Cincinnati

23284

Virginia Commonwealth University, Richmond

23507

Sentara Healthcare, Norfolk

27157

Oregon Health Sciences University, Portland

27710

Henry Ford Health System, Detroit

29425

Temple University, Philadelphia

30078

Piedmont Healthcare, Atlanta

30303

Grady Memorial Hospital, Atlanta

30322

David Geffen School of Medicine at UCLA, Los Angeles

Emory University Hospital, Atlanta

30342

Emory Saint Joseph's Hospital, Atlanta

32209

University of Florida Jacksonville, Jacksonville

37232

Vanderbilt University Medical Center, Nashville

37235

University of Utah, Salt Lake City

43210

Wake Forest University, Winston-Salem

44195

Cleveland Clinic, Cleveland

45241

Ohio State University Wexner Medical Center, Columbus

48109

University of Michigan, Ann Arbor

48202

Hennepin County Medical Center, Minneapolis

55415

University of Maryland School of Medicine, Baltimore

55902

Mayo Clinic, Rochester

68198

University of Nebraska Medical Center, Omaha

70112

Lousiana State University, New Orleans

80045

Maricopa Integrated Health System, Phoenix

80204

Denver Health, Denver

84157

Intermountain Medical Center, Murray

85008

Bon Secours, Richmond

85724

University of Arizona, Tucson

90024

Duke University, Durham

94304

Yale New Haven Hospital, New Haven

01199

Baystate Health, Springfield

All Listed Sponsors
collaborator

The Marcus Foundation

OTHER

lead

Emory University

OTHER

NCT03509350 - Vitamin C, Thiamine, and Steroids in Sepsis | Biotech Hunter | Biotech Hunter