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

Sponsor
Wright State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05355974
Collaborator
(none)
130
Enrollment
1
Location
2
Arms
5.8
Anticipated Duration (Months)
22.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Vasopressor Utilization to Support Mean Arterial Pressure During Rapid Sequence Intubation: A Clinical Trial (Rapid-Press Trial)
Actual Study Start Date :
Aug 9, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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:
  • Ringer's Injection
  • Hartmann's Solution
  • LR

    • 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:
  • Ringer's Injection
  • Hartmann's Solution
  • LR

    • 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Systolic Blood Pressure [1 hour after Rapid Sequence Intubation]

      Change in systolic blood pressure during rapid sequence intubation in mmHg.

    Secondary Outcome Measures

    1. Change in serum creatinine (Acute Kidney Injury) [24 hours after Rapid Sequence Intubation]

      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

    2. Acute Kidney Injury [24 hours after Rapid Sequence Intubation]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Miami Valley Hospital Premier Health Dayton Ohio United States 45409

    Sponsors and Collaborators

    • Wright State University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wright State University
    ClinicalTrials.gov Identifier:
    NCT05355974
    Other Study ID Numbers:
    • IRB-2022-43
    • IRB-2022-43
    First Posted:
    May 2, 2022
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Wright State University
    mean arterial pressure
    Rapid Sequence Intubation
    vasopressor
    Norepinephrine
    Hypotension from Intubation
    Additional relevant MeSH terms:
    Respiratory Insufficiency
    Hypotension
    Norepinephrine
    Plasma-lyte 148

    Study Results

    No Results Posted as of Aug 12, 2022