Clinical trial
Vasopressor Utilization to Support Mean Arterial Pressure During Rapid Sequence Intubation: A Clinical Trial (Rapid-Press Trial)
Name
IRB-2022-43
Description
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.
Trial arms
Trial start
2022-08-09
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Recruiting
Phase
Early phase I
Treatment
Norepinephrine
Norepinephrine continuous infusion at 0.10 mcg/kg/min
Arms:
Norepinephrine plus Isotonic Fluids
Other names:
Levophed, Norepinephrine Bitartrate, Norepinephrine-Dextrose
Lactated Ringers, Intravenous
500mL infusion run at 999mL/hr
Arms:
Isotonic Fluids, Norepinephrine plus Isotonic Fluids
Other names:
Ringer's Injection, Hartmann's Solution, LR
normal saline
500mL infusion run at 999mL/hr
Arms:
Isotonic Fluids, Norepinephrine plus Isotonic Fluids
Other names:
NS, 0.9 percent Sodium Chloride
Plasma-lyte
500mL infusion run at 999mL/hr
Arms:
Isotonic Fluids, Norepinephrine plus Isotonic Fluids
Other names:
Plasma-Lyte 148, Plasmalyte
Size
130
Primary endpoint
Systolic Blood Pressure
1 hour after Rapid Sequence Intubation
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 130, 'type': 'ESTIMATED'}}
Updated at
2024-05-22
1 organization
Organization
Wright State University