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
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia Intubation Complication
• Hypotension
• Hypotension and Shock
• Hypotension on Induction
• Intubation Complication
• Respiratory Failure
• Respiratory Insufficiency

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