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

Primary Purpose

Respiratory Failure, Hypotension and Shock, Hypotension on Induction

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Norepinephrine
Lactated Ringers, Intravenous
normal saline
Plasma-lyte
Sponsored by
Wright State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring mean arterial pressure, Rapid Sequence Intubation, vasopressor, Norepinephrine, Hypotension from Intubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Miami Valley Hospital Premier HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Norepinephrine plus Isotonic Fluids

Isotonic Fluids

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Systolic Blood Pressure
Change in systolic blood pressure during rapid sequence intubation in mmHg.

Secondary Outcome Measures

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
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

Full Information

First Posted
April 25, 2022
Last Updated
April 17, 2023
Sponsor
Wright State University
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1. Study Identification

Unique Protocol Identification Number
NCT05355974
Brief Title
Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure
Acronym
RAPID PRESS
Official Title
Vasopressor Utilization to Support Mean Arterial Pressure During Rapid Sequence Intubation: A Clinical Trial (Rapid-Press Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wright State University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Hypotension and Shock, Hypotension on Induction, Intubation Complication, Anesthesia Intubation Complication
Keywords
mean arterial pressure, Rapid Sequence Intubation, vasopressor, Norepinephrine, Hypotension from Intubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Norepinephrine plus Isotonic Fluids
Arm Type
Experimental
Arm Description
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.
Arm Title
Isotonic Fluids
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
Levophed, Norepinephrine Bitartrate, Norepinephrine-Dextrose
Intervention Description
Norepinephrine continuous infusion at 0.10 mcg/kg/min
Intervention Type
Drug
Intervention Name(s)
Lactated Ringers, Intravenous
Other Intervention Name(s)
Ringer's Injection, Hartmann's Solution, LR
Intervention Description
500mL infusion run at 999mL/hr
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
NS, 0.9 percent Sodium Chloride
Intervention Description
500mL infusion run at 999mL/hr
Intervention Type
Drug
Intervention Name(s)
Plasma-lyte
Other Intervention Name(s)
Plasma-Lyte 148, Plasmalyte
Intervention Description
500mL infusion run at 999mL/hr
Primary Outcome Measure Information:
Title
Systolic Blood Pressure
Description
Change in systolic blood pressure during rapid sequence intubation in mmHg.
Time Frame
1 hour after Rapid Sequence Intubation
Secondary Outcome Measure Information:
Title
Change in serum creatinine (Acute Kidney Injury)
Description
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
Time Frame
24 hours after Rapid Sequence Intubation
Title
Acute Kidney Injury
Description
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
Time Frame
24 hours after Rapid Sequence Intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yonatan Dollin, DO
Phone
(937) 208-2866
Email
yonatan.dollin@wright.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Koroscil, MD
Organizational Affiliation
Wright State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yonatan Dollin, DO
Organizational Affiliation
Wright State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Valley Hospital Premier Health
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Whitney Mcallister
Phone
937-775-4462
Email
whitney.mcallister@wright.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is currently no plan to share IPD

Learn more about this trial

Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure

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