Skip to main content
OpenTrials
Completed

NCT Number: NCT05355974

Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Failure Anesthesia Intubation Complication Cardiovascular Diseases Hypotension Hypotension and Shock Hypotension on Induction Intubation Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Shock Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Miami Valley Hospital Premier Health

Dayton, Ohio, 45409, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

norepinephrine

Drug

Norepinephrine continuous infusion at 0.10 mcg/kg/min

Other names: Levophed, Norepinephrine Bitartrate, Norepinephrine-Dextrose

Lactated Ringers, Intravenous

Drug

500mL infusion run at 999mL/hr

Other names: Ringer's Injection, Hartmann's Solution, LR

normal saline

Drug

500mL infusion run at 999mL/hr

Other names: NS, 0.9 percent Sodium Chloride

Plasma-Lyte

Drug

500mL infusion run at 999mL/hr

Other names: Plasma-Lyte 148, Plasmalyte

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: 1 hour after Rapid Sequence Intubation

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

Secondary outcomes

  1. Change in serum creatinine (Acute Kidney Injury)

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Wright State University

Other

Registry information

Official study title

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

Acronym: RAPID PRESS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 2, 2022
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.