Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

PHASE3CompletedINTERVENTIONAL
Enrollment

1,563

Participants

Timeline

Start Date

March 7, 2018

Primary Completion Date

May 10, 2022

Study Completion Date

August 24, 2022

Conditions
Septic Shock
Interventions
DRUG

Early Vasopressors

"Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. Rescue fluids may be administered as 500ml boluses if predefined rescue criteria are met."

OTHER

Early Fluids

"Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. Rescue vasopressors may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted."

Trial Locations (50)

10029

Mt. Sinai Hospital, New York

10467

Montefiore Medical Center, New York

15261

UPMC Mercy, Pittsburgh

UPMC Presbyterian, Pittsburgh

UPMC Shadyside, Pittsburgh

17033

Penn State Hershey Medical Center, Hershey

19140

Temple University Hospital, Philadelphia

22903

University Virginia Medical Center, Charlottesville

23298

VCU Medical Center, Richmond

27157

Wake Forest Baptist Health, Winston-Salem

27710

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

30033

University of North Carolina at Chapel Hill, Chapel Hill

37221

Vanderbilt University Medical Center, Nashville

39216

University of Mississippi Medical Center, Jackson

40506

University of Kentucky, Lexington

43210

Ohio State University Wexner Medical Center, Columbus

44195

Cleveland Clinic Foundation, Cleveland

45219

University of Cincinnati Medical Center, Cincinnati

46202

Indiana University Health Methodist Hospital, Indianapolis

48109

University of Michigan Medical Center, Ann Arbor

55414

University of Minnesota Medical Center, Minneapolis

55415

Hennepin County Medical Center, Minneapolis

70112

University Medical Center (LSU), New Orleans

77030

University of Texas Health Science Center, Houston

80045

University of Colorado Hospital, Aurora

80204

Denver Health Medical Center, Denver

80218

St. Joseph Hospital, Denver

84107

Intermountain Medical Center, Murray

84132

University of Utah Health Sciences Center, Salt Lake City

84143

LDS Hospital, Salt Lake City

84403

McKay-Dee Hospital, Ogden

84604

Utah Valley Regional Medical Center, Provo

85724

University of Arizona, Tucson

90095

Ronald Reagan UCLA, Los Angeles

93701

UCSF Fresno, Fresno

94143

UCSF San Francisco, San Francisco

94305

Stanford University Hospital, Stanford

97239

Oregon Health and Science University OHSU, Portland

98104

Harborview Medical Center, Seattle

University of Washington Medical Center, Seattle

98122

Swedish Hospital First Hill, Seattle

06519

Yale New Haven Hospital, New Haven

04102

Maine Medical Center, Portland

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

02215

Beth Israel Medical Center, Boston

02445

Brigham and Women's Hospital, Boston

01199

Baystate Medical Center, Springfield

01608

St. Vincent Hospital, Worcester

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER

NCT03434028 - Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis | Biotech Hunter | Biotech Hunter