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Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation (PREPARE II)

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ClinicalTrials.gov Identifier: NCT03787732
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Semler, Vanderbilt University Medical Center

Brief Summary:
Complications are common during tracheal intubation of critically ill patients. Nearly one in five patients undergoing intubation in the intensive care unit experiences cardiovascular collapse, defined as severe hypotension, vasopressor administration, cardiac arrest or death. Cardiovascular collapse during intubation is associated with increased resource utilization and decreased survival. Administration of 500 mL of intravenous crystalloid solution beginning prior to induction may prevent cardiovascular collapse. The only prior trial examining fluid bolus administration during intubation found no effect on cardiovascular collapse or clinical outcomes overall, but a hypothesis-generating subgroup analysis suggested potential benefit to fluid bolus administration among patients receiving positive pressure ventilation between induction and laryngoscopy. Therefore, we propose a randomized trial comparing fluid bolus administration versus none with regard to cardiovascular collapse among critically adults undergoing intubation with positive pressure ventilation between induction and laryngoscopy.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Intubation Complication Hypotension on Induction Drug: Fluid Bolus Other: No Fluid Bolus Phase 4

Detailed Description:

The PREPARE II trial is a prospective, parallel group, pragmatic, randomized trial comparing the effect of a preintubation fluid bolus to no preintubation fluid bolus on the incidence of cardiovascular collapse during and after endotracheal intubation in critically ill adults.

Patients admitted to the study units who are deemed by their clinical team to require intubation and fulfill inclusion criteria without meeting exclusion criteria will be randomized 1:1 to receive either an intravenous fluid bolus or no intravenous fluid bolus. All other decisions regarding airway management will remain at the discretion of the treating provider. The trial will enroll 750 patients. Conduct of the trial will be overseen by a Data Safety Monitoring Board. An interim analysis will be performed after the enrollment of 375 patients. The analysis of the trial will be conducted in accordance with a pre-specified statistical analysis plan, which will be submitted for publication or made publicly available prior to the conclusion of enrollment.

The primary outcome is cardiovascular collapse - a composite endpoint defined as one or more of the following:

  1. Death within 1 hour of intubation
  2. Cardiac arrest within 1 hour of intubation
  3. New systolic blood pressure < 65 mmHg between induction and 2 minutes after completion of intubation
  4. New or increased vasopressor receipt between induction and 2 minutes after completion of intubation

The secondary outcome is 28-day in-hospital mortality


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation (PREPARE II Trial)
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : September 2021


Arm Intervention/treatment
Active Comparator: Fluid Bolus
For patients randomized to fluid bolus administration, the bedside nurse will obtain 500 mL of a crystalloid solution of the operator's choosing, connect this volume to intravenous infusion tubing, and attach the tubing to any intravenous catheter or intraosseous device. The crystalloid solution will then be placed above the level of the intravenous or intraosseous device and allowed to infuse by gravity or pressure bag. At any time after the initiation of fluid bolus administration, the operator can choose to begin the procedure by administering sedation. Fluid loading will continue until all 500 mL are infused. Fluid infusing prior to the decision to perform endotracheal intubation will not be altered by the current study.
Drug: Fluid Bolus
500 milliliters of an intravenous crystalloid solution of the operator's choosing
Other Name: intravenous crystalloid fluid, 500 mL

Active Comparator: No Fluid Bolus
For patients randomized to no fluid bolus administration, no additional intravenous crystalloid administration will be initiated between randomization and two minutes after completion of endotracheal intubation. Fluid infusing prior to the decision to perform endotracheal intubation will not be affected by the study. Treating clinicians may initiate a fluid bolus at any time for the treatment of cardiovascular collapse (not considered a protocol violation). Treating clinicians may also initiate a fluid bolus at any time if felt to be mandatory for the safe treatment of the patient (if between randomization and two minutes after intubation and in the absence of cardiovascular collapse this will be recorded as a protocol violation).
Other: No Fluid Bolus
No additional intravenous crystalloid administration initiated between randomization and two minutes after completion of endotracheal intubation




Primary Outcome Measures :
  1. Cardiovascular collapse [ Time Frame: 1 hour ]

    A composite endpoint defined as one or more of the following

    • New systolic blood pressure < 65 mmHg between induction and 2 minutes after intubation
    • New or increased vasopressor between induction and 2 minutes after intubation
    • Cardiac arrest within 1 hour of intubation
    • Death within 1 hour of intubation


Secondary Outcome Measures :
  1. 28-day in-hospital mortality [ Time Frame: 28 days ]

Other Outcome Measures:
  1. New systolic blood pressure < 65 mmHg between induction and 2 minutes after intubation [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  2. New or increased vasopressor between induction and 2 minutes after intubation [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  3. Cardiac arrest within 1 hour of intubation [ Time Frame: 1 hour ]
  4. Death within 1 hour of intubation [ Time Frame: 1 hour ]
  5. Lowest systolic blood pressure between induction and 2 minutes after intubation [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  6. Change in systolic blood pressure from induction to lowest systolic blood pressure [ Time Frame: between induction and 2 minutes following procedure ]
  7. Vasopressor-free days [ Time Frame: 28 days ]
  8. Ventilator-free days [ Time Frame: 28 days ]
  9. ICU-free days [ Time Frame: 28 days ]
  10. Lowest oxygen saturation [ Time Frame: from induction to 2 minutes following tracheal intubation ]
    Lowest arterial oxygen saturation between induction and 2 minutes after intubation

  11. Incidence of hypoxemia [ Time Frame: from induction to 2 minutes following tracheal intubation ]
    Incidence of oxygen saturation < 90% between induction and 2 minutes after intubation

  12. Incidence of severe hypoxemia [ Time Frame: from induction to 2 minutes following tracheal intubation ]
    Incidence of oxygen saturation < 80% between induction and 2 minutes after intubation

  13. Oxygen saturation at 24 hours after intubation [ Time Frame: 24 hours ]
  14. Fraction of inspired oxygen at 24 hours after intubation [ Time Frame: 24 hours ]
  15. Positive end expiratory pressure at 24 hours after intubation [ Time Frame: 24 hours ]
  16. Systolic blood pressure at 24 hours after intubation [ Time Frame: 24 hours ]
  17. Additional intravenous fluids initiated between induction and 2 minutes after intubation [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  18. Time from induction to successful intubation [ Time Frame: Duration of procedure (minutes) ]
  19. Cormack-Lehane grade of glottic view on first attempt [ Time Frame: Duration of procedure (minutes) ]
  20. Difficulty of intubation [ Time Frame: Duration of procedure (minutes) ]
    Operator-reported difficulty of intubation on a three-point ordinal scale of: easy, moderate, or difficult.

  21. Incidence of successful intubation on the first laryngoscopy attempt [ Time Frame: Duration of procedure (minutes) ]
  22. Number of laryngoscopy attempts [ Time Frame: Duration of procedure (minutes) ]
  23. Need for additional airway equipment or a second operator [ Time Frame: Duration of procedure (minutes) ]


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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:

  1. Patient is undergoing endotracheal intubation in a participating unit
  2. Planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
  3. Patient is at least 18 years of age
  4. Administration of sedation is planned (with or without neuromuscular blockade)
  5. Positive pressure ventilation between induction and laryngoscopy is planned (e.g., non-invasive ventilation or bag-mask ventilation)

Exclusion Criteria:

  1. Prisoners
  2. Pregnant patients
  3. Urgency of intubation precludes safe performance of study procedures
  4. Operator feels administration of a fluid bolus is indicated or contraindicated for the safe performance of the procedure

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): NCT03787732


Contacts
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Contact: Jonathan D Casey, MD (615) 208-6139 Jonathan.d.Casey@vumc.org
Contact: Matthew W. Semler, MD, MSc (615) 802-8428 matthew.w.semler@vumc.org

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Derek W Russell, MD    205-975-3718    dwrussell@uabmc.edu   
United States, Louisiana
Louisiana State University School of Medicine Recruiting
New Orleans, Louisiana, United States, 70112
Contact: David R Janz, MD, MSc    504-568-3167    djanz@lsuhsc.edu   
Ochsner Medical Center | Ochsner Health System Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Kevin M Dischert, MD       kevin.dischert@ochsner.org   
Contact: Derek J Vonderhaar, MD       dvonde@lsuhsc.edu   
United States, Massachusetts
Lahey Hospital & Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: James Dargin, MD       james.m.dargin@lahey.org   
Contact: Sue Stempek, PA-C       susan.b.stempek@lahey.org   
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Kevin Gibbs       kgibbs@wakehealth.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37209
Contact: Jonathan D Casey, MD    615-322-3412    jonathan.d.casey@vanderbilt.edu   
Contact: Matthew W Semler, MD, MSc    615-802-8428    matthew.w.semler@vanderbilt.edu   
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Aaron M Joffe, DO       joffea@uw.edu   
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: David R Janz, MD, MSCI Louisiana State University Health Sciences Center in New Orleans
Principal Investigator: Derek W Russell, MD University of Alabama at Birmingham

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Responsible Party: Matthew Semler, Assistant Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03787732     History of Changes
Other Study ID Numbers: IRB# 181690
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthew Semler, Vanderbilt University Medical Center:
Intubation

Additional relevant MeSH terms:
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Hypotension
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Shock
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Pathologic Processes