Respiratory FailurePhase 3RAPID PRESSNCT05355974
Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure
A Phase 3 study testing Norepinephrine, Lactated Ringers, Intravenous and normal saline in people with Respiratory Failure and Hypotension and Shock, run by Wright State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Hypotension and Shock, Hypotension on Induction
- What is being tested?
- Norepinephrine, Lactated Ringers, Intravenous and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2022to 10 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Respiratory Failure Requiring Intubation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami Valley Hospital Premier Health
Dayton, Ohio, 45409
About this study
Official title: 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.
Read the detailed description
Aim: Prevent 25-46 percent reduction in systolic blood pressure associated with rapid sequence intubation with norepinephrine compared to isotonic fluids alone.
- Conditions
- Respiratory Failure, Hypotension and Shock, Hypotension on Induction, Intubation Complication, Anesthesia Intubation Complication
- Being tested
- Norepinephrine, Lactated Ringers, Intravenous, normal saline, Plasma-lyte
- Keywords
- mean arterial pressure, Rapid Sequence Intubation, vasopressor, Norepinephrine, Hypotension from Intubation
- Medical subject headings
- Respiratory Insufficiency, Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called Levophed, Norepinephrine Bitartrate, Norepinephrine-Dextrose
Norepinephrine continuous infusion at 0.10 mcg/kg/min
Lactated Ringers, IntravenousDrug
Also called Ringer's Injection, Hartmann's Solution, LR
500mL infusion run at 999mL/hr
normal salineDrug
Also called NS, 0.9 percent Sodium Chloride
500mL infusion run at 999mL/hr
Plasma-lyteDrug
Also called Plasma-Lyte 148, Plasmalyte
500mL infusion run at 999mL/hr
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine plus Isotonic Fluids | Experimental | 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. Receives: Drug: Norepinephrine; Drug: Lactated Ringers, Intravenous; Drug: normal saline; Drug: Plasma-lyte |
| Isotonic Fluids | Active comparator | 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. Receives: Drug: Lactated Ringers, Intravenous; Drug: normal saline; Drug: Plasma-lyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Change in systolic blood pressure during rapid sequence intubation in mmHg.
Measured: 1 hour after Rapid Sequence Intubation
Secondary outcomes (2)
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
Measured: 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
Measured: 24 hours after Rapid Sequence Intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start9 Aug 2022
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Koroscil, MD, Principal investigator, Wright State UniversityYonatan Dollin, DO, Principal investigator, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355974
- Sponsor's protocol ID
- IRB-2022-43
- Other IDs
- IRB-2022-43
- Acronym
- RAPID PRESS
- Status last verified
- Jul 2024
- First submitted
- 25 Apr 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressor Utilization to Support Mean Arterial Pressure During Rapid Sequence Intubation: A Clinical Trial (Rapid-Press Trial)
- ClinicalTrials.gov ID
- NCT05355974
- Acronym / sponsor ID
- RAPID PRESS / IRB-2022-43
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine plus Isotonic Fluids | Experimental | Drug: Norepinephrine, Drug: Lactated Ringers, Intravenous, Drug: normal saline, Drug: Plasma-lyteThe 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. |
| Isotonic Fluids | Active comparator | Drug: Lactated Ringers, Intravenous, Drug: normal saline, Drug: Plasma-lyteThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Respiratory Failure Requiring Intubation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorepinephrineAlso: Levophed, Norepinephrine Bitartrate, Norepinephrine-DextroseNorepinephrine continuous infusion at 0.10 mcg/kg/min | Drug | Norepinephrine plus Isotonic Fluids |
| Lactated Ringers, IntravenousAlso: Ringer's Injection, Hartmann's Solution, LR500mL infusion run at 999mL/hr | Drug | Isotonic Fluids, Norepinephrine plus Isotonic Fluids |
| normal salineAlso: NS, 0.9 percent Sodium Chloride500mL infusion run at 999mL/hr | Drug | Isotonic Fluids, Norepinephrine plus Isotonic Fluids |
| Plasma-lyteAlso: Plasma-Lyte 148, Plasmalyte500mL infusion run at 999mL/hr | Drug | Isotonic Fluids, Norepinephrine plus Isotonic Fluids |
Primary outcome
Systolic Blood Pressure
Time frame: 1 hour after Rapid Sequence Intubation
Change in systolic blood pressure during rapid sequence intubation in mmHg.
2 secondary outcomes
Change in serum creatinine (Acute Kidney Injury)
Time frame: 24 hours after Rapid Sequence Intubation
Acute Kidney Injury
Time frame: 24 hours after Rapid Sequence Intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No. There is currently no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Koroscil, MD principal investigator
Wright State University
Yonatan Dollin, DO principal investigator
Wright State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Norepinephrine, Lactated Ringers, Intravenous and normal saline in people with Respiratory Failure and Hypotension and Shock, run by Wright State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: 1 hour after Rapid Sequence Intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.