NCT03787732: PREPARE II

Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation

Completed Phase 4 Last updated 12 August 2021

What this trial tests

Phase 4 trial testing Fluid Bolus in Acute Respiratory Failure in 1,067 participants. Completed in 21 June 2021.

Timeline

1 February 2019

Primary endpoint
24 May 2021

21 June 2021

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,067
Start date	1 February 2019
Primary completion	24 May 2021
Estimated completion	21 June 2021
Sites	11 locations across United States

Drugs / interventions tested

• Fluid Bolus — full drug profile →
• No Fluid Bolus

Conditions studied

• Acute Respiratory Failure — all drugs for Acute Respiratory Failure →
• Intubation Complication — all drugs for Intubation Complication →
• Hypotension on Induction — all drugs for Hypotension on Induction →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Acute Respiratory Failure or Intubation Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Fluid Bolus Administration on Cardiovascular Collapse Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial.
   Russell DW, Casey JD, Gibbs KW, Ghamande S, et al · · 2022 · cited 76× · PMID 35707974 · DOI 10.1001/jama.2022.9792
2. Risk Factors for Cardiovascular Collapse during Tracheal Intubation of Critically III Adults.
   Halliday SJ, Casey JD, Rice TW, Semler MW, et al · · 2020 · cited 12× · PMID 32364753 · DOI 10.1513/annalsats.201912-894rl
3. Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial.
   Russell DW, Casey JD, Gibbs KW, Dargin JM, et al · · 2020 · cited 4× · PMID 32948554 · DOI 10.1136/bmjopen-2019-036671
4. Equity of participants in clinical trials in critical care and perioperative medicine research: a systematic review.
   Wong JKL, Thomas C, Gravett H, Thobhani K, et al · · 2025 · cited 1× · PMID 40746650 · DOI 10.1016/j.bjao.2025.100425