Back to resultsPropofol Versus Esketamine for Rapid Sequence Intubation in Critically Ill Patients (PROMINA)
Primary Purpose
Acute Respiratory Failure
Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Esketamine hydrochloride
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Failure
Eligibility Criteria
Inclusion Criteria:
- Age above 18 years old
- Physician indicated intubation
Exclusion Criteria:
- Pregnancy
- Intubation during cardiac arrest
- Known of suspected intracranial hypertension
- Known allergy to propofol or esketamine
- Bradycardia (heart rate below 50 beats per minute) or atrioventricular block
Sites / Locations
- Federal University of São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Propofol
Esketamina
Arm Description
Outcomes
Primary Outcome Measures
Lowest mean blood pressure
Lowest mean blood pressure
Secondary Outcome Measures
Early death
Death within one hour of intubation
Cardiac arrest
Cardiac arrest requiring resuscitation
Severe hypotension
Systolic blood pressure below 80 mmHg
Severe hypoxemia
Peripheral oxygen saturation below 85%
Number of intubation attempts
Number of attempts
Full Information
NCT ID
NCT05092152
First Posted
October 13, 2021
Last Updated
July 12, 2023
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05092152
Brief Title
Propofol Versus Esketamine for Rapid Sequence Intubation in Critically Ill Patients
Acronym
PROMINA
Official Title
Propofol Versus Esketamine for Rapid Sequence Intubation in Critically Ill Patients: A Randomized, Multicenter, Unblinded, Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Rapid-sequence intubation is routinely performed in critically ill patients. It is unclear whether different sedative agents may influence short-term outcomes after intubation, specially hemodynamic stability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Active Comparator
Arm Title
Esketamina
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Esketamine hydrochloride
Intervention Description
2 mg per kilogram of body weight
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
1.5 mg per kilogram of body weight
Primary Outcome Measure Information:
Title
Lowest mean blood pressure
Description
Lowest mean blood pressure
Time Frame
Ten minutes after induction
Secondary Outcome Measure Information:
Title
Early death
Description
Death within one hour of intubation
Time Frame
One hour
Title
Cardiac arrest
Description
Cardiac arrest requiring resuscitation
Time Frame
One hour
Title
Severe hypotension
Description
Systolic blood pressure below 80 mmHg
Time Frame
One hour
Title
Severe hypoxemia
Description
Peripheral oxygen saturation below 85%
Time Frame
One hour
Title
Number of intubation attempts
Description
Number of attempts
Time Frame
One hour
Other Pre-specified Outcome Measures:
Title
Cumulative vasopressor use
Description
Cumulative, in milligrams, dose of vasopressors used
Time Frame
24 hours after intubation
Title
Maximum heart rate
Description
Maximum heart rate
Time Frame
One hour
Title
Days alive and free of mechanical ventilation
Description
Days patient spend alive and free of mechanical ventilation in the first seven days after intubation
Time Frame
Seven days
Title
Mortality in the Intensive Care Unit
Description
Mortality in the Intensive Care Unit
Time Frame
28 days
Title
Mortality in hospital
Description
Mortality in hospital
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age above 18 years old
Physician indicated intubation
Exclusion Criteria:
Pregnancy
Intubation during cardiac arrest
Known of suspected intracranial hypertension
Known allergy to propofol or esketamine
Bradycardia (heart rate below 50 beats per minute) or atrioventricular block
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raysa Schmidt, MD
Phone
+551155764848
Email
csraysa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Flavia R Machado, MD, PhD
Phone
+551155764848
Ext
17018
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavia R Machado, MD, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Raysa Schmidt, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04038002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raysa Schmidt, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
6 months after trial finished enrolling
IPD Sharing Access Criteria
Upon reasonable request
Learn more about this trial
Propofol Versus Esketamine for Rapid Sequence Intubation in Critically Ill Patients
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