Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure (RAPID PRESS)

Vasopressor Utilization to Support Mean Arterial Pressure During Rapid Sequence Intubation: A Clinical Trial (Rapid-Press Trial)

The purpose of this study is to investigate whether protocolized vasopressor use for patients with normal blood pressure undergoing rapid sequence intubation improves hemodynamic parameters and mitigates adverse events.

The hypothesis is that use of vasopressors during Rapid Sequence Intubation will prevent substantial decreases in blood pressure when compared to normal intravenous fluids.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Intubation Complication; Anesthesia Intubation Complication; Hypotension and Shock; Hypotension on Induction
• Intervention / Treatment: Drug: Norepinephrine; Drug: Lactated Ringers, Intravenous; Drug: normal saline; Drug: Plasma-lyte

Detailed Description

Aim: Prevent 25-46 percent reduction in systolic blood pressure associated with rapid sequence intubation with norepinephrine compared to isotonic fluids alone.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yonatan Dollin, DO; Phone Number: (937) 208-2866; Email: yonatan.dollin@wright.edu

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45409
      • Recruiting
      • Miami Valley Hospital Premier Health
      • Contact: Whitney Mcallister; Phone Number: 937-775-4462; Email: whitney.mcallister@wright.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Respiratory Failure Requiring Intubation

Exclusion Criteria:

• Pregnancy
• Patients intubated during code blue clinical scenarios
• Requiring surgical airway
• Failed intubations
• MAP less than 65 or Systolic Blood Pressure (SBP) less than 90mmHg pre-intubation
• Systolic blood pressure greater than 150mmHg
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Norepinephrine plus Isotonic Fluids; The treatment group will receive a continuous infusion of norepinephrine at 0.10 mcg/kg/min started 2-5 minutes prior to Rapid Sequence Intubation (assuming normal systolic blood pressure 90-140mmHg) in addition to a standard fluid bolus of Lactated Ringers or Normal Saline or Plasmalyte at 999 mL/hr.	Drug: Norepinephrine; Norepinephrine continuous infusion at 0.10 mcg/kg/min; Other Names: Levophed; Norepinephrine Bitartrate; Norepinephrine-Dextrose; Drug: Lactated Ringers, Intravenous; 500mL infusion run at 999mL/hr; Other Names: LR; Hartmann's Solution; Ringer's Injection; Drug: normal saline; 500mL infusion run at 999mL/hr; Other Names: NS; 0.9 percent Sodium Chloride; Drug: Plasma-lyte; 500mL infusion run at 999mL/hr; Other Names: Plasma-Lyte 148; Plasmalyte
Active Comparator: Isotonic Fluids; The control group will receive an infusion of Lactated Ringers or Normal Saline or Plasma-Lyte with at least 500 mL at 999 ml/hr 2-5 minutes prior to Rapid Sequence Intubation.	Drug: Lactated Ringers, Intravenous; 500mL infusion run at 999mL/hr; Other Names: LR; Hartmann's Solution; Ringer's Injection; Drug: normal saline; 500mL infusion run at 999mL/hr; Other Names: NS; 0.9 percent Sodium Chloride; Drug: Plasma-lyte; 500mL infusion run at 999mL/hr; Other Names: Plasma-Lyte 148; Plasmalyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	Change in systolic blood pressure during rapid sequence intubation in mmHg.	1 hour after Rapid Sequence Intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum creatinine (Acute Kidney Injury)	Change in serum creatinine (in mL) after rapid sequence intubation and development of Acute Kidney Injury as defined by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours	24 hours after Rapid Sequence Intubation
Acute Kidney Injury	Change in urine output (in mL) after rapid sequence intubation and development of Acute Kidney Injury as defined by Urine volume <0.5 mL/kg/hour for six hours	24 hours after Rapid Sequence Intubation

Collaborators and Investigators

• Sponsor: Wright State University
• Investigators: Principal Investigator: Matthew Koroscil, MD, Wright State University; Principal Investigator: Yonatan Dollin, DO, Wright State University

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Norepinephrine; vasopressor; mean arterial pressure; Rapid Sequence Intubation; Hypotension from Intubation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Pharmaceutical Solutions; Sympathomimetics; Vasoconstrictor Agents; Ophthalmic Solutions; Norepinephrine; Plasma-lyte 148
• Other Study ID Numbers: IRB-2022-43 (Other Identifier: Wright State University IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is currently no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No