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Vasopressor Medication
Vasopressors for Low Blood Pressure During Intubation (RAPID PRESS Trial)
Phase 3
Recruiting
Led By Yonatan Dollin, DO
Research Sponsored by Wright State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Respiratory Failure Requiring Intubation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour after rapid sequence intubation
Awards & highlights
RAPID PRESS Trial Summary
This trial will help determine whether using vasopressors can improve patient outcomes by preventing drops in blood pressure during RSI.
Who is the study for?
This trial is for patients with respiratory failure who need intubation but have normal blood pressure. It's not for pregnant individuals, prisoners, those needing a surgical airway or failed intubations, and anyone with high systolic blood pressure (>150mmHg) or low MAP (<65) or SBP (<90mmHg).Check my eligibility
What is being tested?
The study tests if vasopressors like Norepinephrine can help maintain blood pressure during rapid sequence intubation better than standard IV fluids such as Lactated Ringers, normal saline, or Plasma-lyte.See study design
What are the potential side effects?
Possible side effects of vasopressors may include irregular heartbeats, headache, nervousness; while IV fluids might cause swelling or electrolyte imbalances.
RAPID PRESS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a machine to help me breathe.
RAPID PRESS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour after rapid sequence intubation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour after rapid sequence intubation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Systolic Blood Pressure
Secondary outcome measures
Acute Kidney Injury
Change in serum creatinine (Acute Kidney Injury)
Side effects data
From 2015 Phase 4 trial • 85 Patients • NCT0235483363%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phenylephrine
Norepinephrine
RAPID PRESS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Norepinephrine plus Isotonic FluidsExperimental Treatment4 Interventions
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.
Group II: Isotonic FluidsActive Control3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Norepinephrine
2014
Completed Phase 4
~1780
Lactated Ringers, Intravenous
2022
Completed Phase 2
~30
normal saline
2010
Completed Phase 4
~2680
Find a Location
Who is running the clinical trial?
Wright State UniversityLead Sponsor
41 Previous Clinical Trials
54,752 Total Patients Enrolled
Yonatan Dollin, DOPrincipal InvestigatorWright State University
Matthew Koroscil, MDPrincipal InvestigatorWright State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You were put on a breathing tube during a medical emergency.I need surgery to help me breathe.I need a machine to help me breathe.Your blood pressure is higher than 150mmHg when the heart is pumping.Previous attempts to insert a breathing tube were not successful.Your blood pressure is too low before getting a breathing tube.
Research Study Groups:
This trial has the following groups:- Group 1: Norepinephrine plus Isotonic Fluids
- Group 2: Isotonic Fluids
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Norepinephrine have any short-term or long-term adverse effects?
"Norepinephrine receives a score of 3 on Power's safety scale. This is because Norepinephrine is in Phase 3 of clinical trials, so there is some evidence of efficacy as well as multiple rounds of data supporting safety."
Answered by AI
How many total individuals are enrolled in this experiment?
"Yes, that is accurate. The public clinicaltrials.gov website says this trial is open and looking for volunteers. The listing says the study was posted on 8/9/2022 and last updated on the same day. They are looking for a total of 130 people at 1 site."
Answered by AI
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