Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation



Status:Completed
Conditions:Hospital, Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:2/1/2018
Start Date:January 2017
End Date:January 2018

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Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation: The PrePARE Trial

Endotracheal intubation is common in the care of critically ill patients. Complications of
airway management in this setting are frequently encountered and may be associated with an
increased risk of death. The prevention of complications during urgent and emergent
endotracheal intubation is a key focus for airway management research. Post-intubation
hypotension (PIH), a common complication of endotracheal intubation in the critically ill,
may be prevented by a bolus of intravenous fluid prior to the start of the procedure, but
this approach has not been examined in a prospective trial. There are no randomized trials of
intravenous fluid administration to prevent PIH in critically ill adults. The investigators
propose a randomized trial of fluid loading to prevent PIH in critically ill adults.

The investigators propose a randomized, parallel-group trial evaluating the impact of fluid
loading to decrease cardiovascular collapse during and after endotracheal intubation in
critically ill adults. Patients admitted to the study sites who are deemed by their clinical
team to require intubation and fulfill inclusion criteria without meeting exclusion criteria
will be enrolled and randomly assigned to intravenous fluid loading versus none. All other
decisions regarding airway management will remain at the discretion of the treating provider.
Data will be collected at the time of intubation and prospectively from the medical record in
order to determine the effect of the assigned intervention on short- and long-term outcomes.
All data are collected non-invasively and are already a part of clinical data obtained in
usual ICU care at the bedside or in the medical record. No additional data will be collected
that is not observed at the bedside or obtained from the medical record.

Study Population: The study population will be all critically ill adults for whom the
clinical team has decided to perform endotracheal intubation using sedation with or without
neuromuscular blockade. Patients will be excluded only if the operator feels: 1. Additional
intravenous fluids in the form of fluid loading is absolutely indicated or contraindicated,
or 2. The urgency of the intubation would make performing the study procedures unsafe.
Patients will be included regardless of gender, race, weight or body mass index, initial
oxygen saturation, anticipated grade of view, and other clinical factors.

Study Interventions:

Fluid Loading - (1) 500 milliliters of an intravenous crystalloid solution of the operator's
choosing will be (2) infused at any time after randomization and prior to the administration
of procedural medications from (3) above the level of the central or peripheral intravenous
or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have
infused. All intravenous infusions preceding the decision to perform endotracheal intubation
will not be altered.

No Fluid Loading - No intravenous fluids are started after the decision is made to perform
endotracheal intubation. All intravenous infusions preceding the decision to perform
endotracheal intubation will not be altered.

Primary Endpoint:

Cardiovascular collapse - a composite endpoint defined as one or more of the following:

- Death within 1 hour of intubation

- Cardiac arrest within 1 hour of intubation

- New systolic blood pressure < 65 mmHg between induction and 2 minutes after completion
of intubation

- New or increased vasopressor receipt between induction and 2 minutes after completion of
intubation

Inclusion Criteria:

- Patient is admitted to participating study unit

- Planned procedure is endotracheal intubation and planned operator is a provider
expected to routinely perform endotracheal intubation in the participating unit

- Administration of sedation with or without neuromuscular blockade is planned

- Age ≥ 18 years old

Exclusion Criteria:

- Operator believes fluid loading to be absolutely indicated or contraindicated for the
safe care of the patient

- Urgency of intubation precludes safe performance of study procedures

- Pregnancy

- Prisoners

- Age < 18 years old
We found this trial at
7
sites
Bronx, New York 10451
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-322-3412
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Burlington, Massachusetts 01860
Principal Investigator: James Dargin, MD
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Burlington, MA
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1514 Jefferson Highway
Jefferson, Louisiana 70121
Phone: 504-568-3167
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Jefferson, LA
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433 Bolivar Street
New Orleans, Louisiana 70112
Phone: 504-568-3167
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New Orleans, LA
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