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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
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
David Janz, Louisiana State University Health Sciences Center in New Orleans

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Intubation Complication Drug: intravenous crystalloid fluid, 500 mL Phase 4

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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.
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. In-hospital mortality [ Time Frame: from date of randomization through study completion, an average of 28 days ]
  2. Ventilator-free days [ Time Frame: from date of randomization through study completion, an average of 28 days ]
  3. ICU-free days [ Time Frame: from date of randomization through study completion, an average of 28 days ]
  4. lowest arterial oxygen saturation [ Time Frame: between induction and 2 minutes following procedure ]
  5. number of laryngoscopy attempts [ Time Frame: during procedure ]
  6. vasopressor-free days [ Time Frame: from date of randomization through study completion, an average of 28 days ]
  7. lowest systolic blood pressure [ Time Frame: between induction and 2 minutes following procedure ]


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Investigators
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Study Chair: David Janz, MD, MSc LSU School of Medicine New Orleans

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Janz, Assistant Professor of Medicine, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT03026777     History of Changes
Other Study ID Numbers: Prepare
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Respiratory Insufficiency
Shock
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes