Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis



Status:Recruiting
Conditions:Hospital, Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:March 7, 2018
End Date:June 2021
Contact:Katie Oldmixon, RN
Email:coldmixon@mgh.harvard.edu
Phone:617 726-4777

Use our guide to learn which trials are right for you!

Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid
treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The
aim of the study is to determine the impact of a restrictive fluids strategy (vasopressors
first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first
followed by rescue vasopressors) on 90-day in-hospital mortality in patients with
sepsis-induced hypotension.

Primary Hypothesis: Restrictive (vs liberal) fluid treatment strategy during the first 24
hours of resuscitation for sepsis-induced hypotension will reduce 90-day in-hospital
mortality.

1. We will emphasize early screening and protocol initiation, and enroll a maximum of 2320
patients with suspected sepsis-induced hypotension.

- All patients will receive at least 1 liter of fluids prior to meeting study
inclusion criteria (and no more than 3 liters prior to randomization).

- Patients will be enrolled within 4 hours of meeting study inclusion criteria

- Any type of isotonic crystalloid (normal saline, ringers lactate, or a balanced
solution such as plasmalyte) is permitted.

2. Restrictive Fluids (Early Vasopressors) Group

- 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

3. Liberal Fluids (Fluids First) Group

- Additional 2 liter intravenous fluid bolus upon enrollment

- 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

Inclusion Criteria:

- Age ≥ 18 years

- A suspected or confirmed infection (broadly defined by administration or planned
administration of antibiotics)

- Sepsis-induced hypotension defined as systolic blood pressure < 100 mmHg or MAP < 65
mmHg after a minimum of at least 1 liter of fluid (*Fluids inclusive of pre-hospital
fluids; blood pressure must be below any known or reported pre-morbid baseline).

Exclusion Criteria:

- More than 4 hours elapsed since meeting inclusion criteria or 24 hours elapsed since
admission to the hospital

- Patient already received 3 liters of intravenous fluid (includes prehospital volumes)

- Unable to obtain informed consent

- Known pregnancy

- Hypotension suspected to be due to non-sepsis cause (e.g. hemorrhagic shock)

- Blood pressure is at known or reported baseline level

- Severe Volume Depletion from an acute condition other than sepsis. In the judgment of
the treating physician, the patient has an acute condition other than sepsis causing
(or indicative) of *severe volume depletion; Examples include: Diabetic ketoacidosis,
high volume vomiting or diarrhea, hyperosmolar hyperglycemic state, and nonexertional
hyperthermia (heat stroke); severe is defined by the need for substantial intravenous
fluid administration as part of routine clinical care

- Pulmonary edema or clinical signs of new fluid overload (e.g. bilateral crackles, new
oxygen requirement, new peripheral edema, fluid overload on chest x-ray)

- Treating physician unwilling to give additional fluids as directed by the liberal
protocol

- Treating physician unwilling to use vasopressors as directed by the restrictive
protocol.

- Current or imminent decision to withhold most/all life-sustaining treatment; this does
not exclude those patients committed to full support except cardiopulmonary
resuscitation

- Immediate surgical intervention planned such that study procedures could not be
followed

- Prior enrollment in this study
We found this trial at
50
sites
Fresno, California 93702
?
mi
from
Fresno, CA
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
?
mi
from
Portland, ME
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Boston, Massachusetts 02215
?
mi
from
Boston, MA
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22908
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
777 Bannock St
Denver, Colorado 80204
(303) 436-6000
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
?
mi
from
Denver, CO
Click here to add this to my saved trials
Denver, Colorado 80218
?
mi
from
Denver, CO
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Evanston, Illinois 60208
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Minneapolis, Minnesota 55414
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
?
mi
from
Murray, UT
Click here to add this to my saved trials
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10467
?
mi
from
New York, NY
Click here to add this to my saved trials
Ogden, Utah
?
mi
from
Ogden, UT
Click here to add this to my saved trials
3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15219
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Provo, UT
Click here to add this to my saved trials
Richmond, Virginia 23298
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
8th Ave & C St
Salt Lake City, Utah 84143
(801) 408-1100
LDS Hospital LDS Hospital provides clinical excellence to our community in a wide range of...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
505 Parnassus Avenue
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Seattle, Washington 98122
?
mi
from
Seattle, WA
Click here to add this to my saved trials
759 Chestnut Street
Springfield, Massachusetts 01199
(413) 794 - 0000
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
?
mi
from
Springfield, MA
Click here to add this to my saved trials
Stanford, California 94303
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Worcester, Massachusetts 01608
?
mi
from
Worcester, MA
Click here to add this to my saved trials