Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation

NCT03026777 | Completed Phase 4 Results DMC

• 1 other identifier: Prepare
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 7

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.

Conditions

Acute Respiratory Failure; Intubation Complication

Outcome Measures

Primary Outcomes (1)

• 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

  1 hour

Secondary Outcomes (6)

• In-hospital Mortality

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

• Ventilator-free Days

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

• ICU-free Days

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

• Lowest Arterial Oxygen Saturation

  between induction and 2 minutes following procedure

• Number of Laryngoscopy Attempts

  during procedure

Study Arms (2)

Fluid Loading

EXPERIMENTAL

(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

Usual Care

NO INTERVENTION

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.

Interventions

intravenous crystalloid fluid, 500 mL DRUG

Fluid Loading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (7)

University of Alabama Birmingham

Birmingham, Alabama, United States

Location

Ochsner Medical Center

Jefferson, Louisiana, 70121, United States

Location

LSUHSC and University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Lahey Medical Center

Burlington, Massachusetts, 01805, United States

Location

Lincoln Medical Center

The Bronx, New York, 10451, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Janz DR, Casey JD, Semler MW, Russell DW, Dargin J, Vonderhaar DJ, Dischert KM, West JR, Stempek S, Wozniak J, Caputo N, Heideman BE, Zouk AN, Gulati S, Stigler WS, Bentov I, Joffe AM, Rice TW; PrePARE Investigators; Pragmatic Critical Care Research Group. Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial. Lancet Respir Med. 2019 Dec;7(12):1039-1047. doi: 10.1016/S2213-2600(19)30246-2. Epub 2019 Oct 1.

  PMID: 31585796 DERIVED

Results Point of Contact

• Title: Dr. David Janz
• Organization: LSUHSC New Orleans

djanz@lsuhsc.edu

504-913-5006

Study Officials

• David Janz, MD, MSc

  LSU School of Medicine New Orleans

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 20, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12

Locations

US (7)