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NCT05355974 Clinical Trial

Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure

Respiratory Failure Clinical Trial

— RAPID PRESS  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05355974
Other study ID # IRB-2022-43
Secondary ID IRB-2022-43
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 9, 2022
Est. completion date June 2024

Study information
Verified date May 2024
Source Wright State University
Contact Yonatan Dollin, DO
Phone (937) 208-2866
Email yonatan.dollin@wright.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The hypothesis is that use of vasopressors during Rapid Sequence Intubation will prevent substantial decreases in blood pressure when compared to normal intravenous fluids.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 130
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Norepinephrine
Norepinephrine continuous infusion at 0.10 mcg/kg/min
• Lactated Ringers, Intravenous
500mL infusion run at 999mL/hr
• normal saline
500mL infusion run at 999mL/hr
• Plasma-lyte
500mL infusion run at 999mL/hr

Locations
Country Name City State
United States Miami Valley Hospital Premier Health Dayton Ohio

Sponsors (1)
Lead Sponsor Collaborator
Wright State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Systolic Blood Pressure Change in systolic blood pressure during rapid sequence intubation in mmHg. 1 hour after Rapid Sequence Intubation
Secondary 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 24 hours after Rapid Sequence Intubation
Secondary 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 24 hours after Rapid Sequence Intubation
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