Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation (PrePARE)
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ClinicalTrials.gov Identifier: NCT03026777 |
Recruitment Status :
Completed
First Posted : January 20, 2017
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
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Condition or disease | Intervention/treatment | Phase |
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Acute Respiratory Failure Intubation Complication | Drug: intravenous crystalloid fluid, 500 mL | Phase 4 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 337 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation: The PrePARE Trial |
Actual Study Start Date : | January 2017 |
Actual Primary Completion Date : | January 2018 |
Actual Study Completion Date : | January 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Drug: intravenous crystalloid fluid, 500 mL |
No Intervention: Usual Care
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.
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- Number of Participants With Cardiovascular Collapse [ Time Frame: 1 hour ]
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
- In-hospital Mortality [ Time Frame: from date of randomization through study completion, an average of 28 days ]What was the patient's vital status at the time of hospital discharge
- Ventilator-free Days [ Time Frame: from date of randomization through study completion, an average of 28 days ]Number of days alive and free of invasive ventilation in a 28-day period
- ICU-free Days [ Time Frame: from date of randomization through study completion, an average of 28 days ]Number of days alive and outside of an ICU in a 28 day period
- Lowest Arterial Oxygen Saturation [ Time Frame: between induction and 2 minutes following procedure ]Lowest arterial oxygen saturation between induction and 2 min after intubation
- Number of Laryngoscopy Attempts [ Time Frame: during procedure ]Number of laryngoscopy attempts to achieve successful tracheal intubation
- Lowest Systolic Blood Pressure [ Time Frame: between induction and 2 minutes following procedure ]Lowest systolic blood pressure between induction and 2 min after intubation

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026777
United States, Alabama | |
University of Alabama Birmingham | |
Birmingham, Alabama, United States | |
United States, Louisiana | |
Ochsner Medical Center | |
Jefferson, Louisiana, United States, 70121 | |
LSUHSC and University Medical Center | |
New Orleans, Louisiana, United States, 70112 | |
United States, Massachusetts | |
Lahey Medical Center | |
Burlington, Massachusetts, United States, 01805 | |
United States, New York | |
Lincoln Medical Center | |
Bronx, New York, United States, 10451 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98104 |
Study Chair: | David Janz, MD, MSc | LSU School of Medicine New Orleans |
Documents provided by David Janz, Louisiana State University Health Sciences Center in New Orleans:
Responsible Party: | David Janz, Assistant Professor of Medicine, Louisiana State University Health Sciences Center in New Orleans |
ClinicalTrials.gov Identifier: | NCT03026777 |
Other Study ID Numbers: |
Prepare |
First Posted: | January 20, 2017 Key Record Dates |
Results First Posted: | January 5, 2021 |
Last Update Posted: | January 5, 2021 |
Last Verified: | December 2020 |
Respiratory Insufficiency Shock Respiration Disorders Respiratory Tract Diseases Pathologic Processes |