Trial Outcomes & Findings for Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation (NCT NCT03026777)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

337 participants

Primary outcome timeframe

1 hour

Results posted on

2021-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	168	169
Overall Study COMPLETED	168	169
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluid Loading n=168 Participants (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	Usual Care n=169 Participants 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.	Total n=337 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	58 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	73 Participants n=7 Participants	154 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	96 Participants n=7 Participants	183 Participants n=5 Participants
Race/Ethnicity, Customized White Race	115 Participants n=5 Participants	121 Participants n=7 Participants	236 Participants n=5 Participants
Race/Ethnicity, Customized Other	53 Participants n=5 Participants	48 Participants n=7 Participants	101 Participants n=5 Participants
Region of Enrollment United States	168 participants n=5 Participants	169 participants n=7 Participants	337 participants n=5 Participants
Body-mass index	27 kg/m^2 n=5 Participants	26 kg/m^2 n=7 Participants	26 kg/m^2 n=5 Participants
Acute physiology and chronic health evaluation score	21 units on a scale, range 0 to 71 n=5 Participants	20 units on a scale, range 0 to 71 n=7 Participants	20 units on a scale, range 0 to 71 n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: All patients randomized were included in the primary analysis

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