Skip to content

Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03026777
Acronym
PrePARE
Enrollment
337
Registered
2017-01-20
Start date
2017-01-31
Completion date
2018-01-31
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Intubation Complication

Brief summary

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.

Detailed description

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

Interventions

DRUGintravenous crystalloid fluid, 500 mL

Sponsors

Louisiana State University Health Sciences Center in New Orleans
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Cardiovascular Collapse1 houra 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

Secondary

MeasureTime frameDescription
Ventilator-free Daysfrom date of randomization through study completion, an average of 28 daysNumber of days alive and free of invasive ventilation in a 28-day period
ICU-free Daysfrom date of randomization through study completion, an average of 28 daysNumber of days alive and outside of an ICU in a 28 day period
In-hospital Mortalityfrom date of randomization through study completion, an average of 28 daysWhat was the patient's vital status at the time of hospital discharge
Number of Laryngoscopy Attemptsduring procedureNumber of laryngoscopy attempts to achieve successful tracheal intubation
Lowest Systolic Blood Pressurebetween induction and 2 minutes following procedureLowest systolic blood pressure between induction and 2 min after intubation
Lowest Arterial Oxygen Saturationbetween induction and 2 minutes following procedureLowest arterial oxygen saturation between induction and 2 min after intubation

Countries

United States

Participant flow

Participants by arm

ArmCount
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. intravenous crystalloid fluid, 500 mL
168
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.
169
Total337

Baseline characteristics

CharacteristicTotalUsual CareFluid Loading
Acute physiology and chronic health evaluation score20 units on a scale, range 0 to 7120 units on a scale, range 0 to 7121 units on a scale, range 0 to 71
Age, Continuous60 years58 years61 years
Body-mass index26 kg/m^226 kg/m^227 kg/m^2
Race/Ethnicity, Customized
Other
101 Participants48 Participants53 Participants
Race/Ethnicity, Customized
White Race
236 Participants121 Participants115 Participants
Region of Enrollment
United States
337 participants169 participants168 participants
Sex: Female, Male
Female
154 Participants73 Participants81 Participants
Sex: Female, Male
Male
183 Participants96 Participants87 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
48 / 16859 / 169
other
Total, other adverse events
0 / 1680 / 169
serious
Total, serious adverse events
0 / 1680 / 169

Outcome results

Primary

Number of Participants With 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

Time frame: 1 hour

Population: All patients randomized were included in the primary analysis

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Fluid LoadingNumber of Participants With Cardiovascular Collapse33 Participants
Usual CareNumber of Participants With Cardiovascular Collapse31 Participants
Secondary

ICU-free Days

Number of days alive and outside of an ICU in a 28 day period

Time frame: from date of randomization through study completion, an average of 28 days

Population: intention to treat

ArmMeasureValue (MEDIAN)
Fluid LoadingICU-free Days16 days
Usual CareICU-free Days14 days
Secondary

In-hospital Mortality

What was the patient's vital status at the time of hospital discharge

Time frame: from date of randomization through study completion, an average of 28 days

Population: intention to treat

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Fluid LoadingIn-hospital Mortality48 Participants
Usual CareIn-hospital Mortality59 Participants
Secondary

Lowest Arterial Oxygen Saturation

Lowest arterial oxygen saturation between induction and 2 min after intubation

Time frame: between induction and 2 minutes following procedure

Population: intention to treat

ArmMeasureValue (MEDIAN)
Fluid LoadingLowest Arterial Oxygen Saturation94 percentage of hemoglobin
Usual CareLowest Arterial Oxygen Saturation95 percentage of hemoglobin
Secondary

Lowest Systolic Blood Pressure

Lowest systolic blood pressure between induction and 2 min after intubation

Time frame: between induction and 2 minutes following procedure

Population: intention to treat

ArmMeasureValue (MEDIAN)
Fluid LoadingLowest Systolic Blood Pressure119 mmHg
Usual CareLowest Systolic Blood Pressure119 mmHg
Secondary

Number of Laryngoscopy Attempts

Number of laryngoscopy attempts to achieve successful tracheal intubation

Time frame: during procedure

Population: intention to treat

ArmMeasureValue (MEDIAN)
Fluid LoadingNumber of Laryngoscopy Attempts1 attempts
Usual CareNumber of Laryngoscopy Attempts1 attempts
Secondary

Ventilator-free Days

Number of days alive and free of invasive ventilation in a 28-day period

Time frame: from date of randomization through study completion, an average of 28 days

Population: intention to treat

ArmMeasureValue (MEDIAN)
Fluid LoadingVentilator-free Days20 days
Usual CareVentilator-free Days19 days

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026