Effect of push dose Epinephrine on mortality rate following intubation in hypotensive patients
Design
Clinical trial with a historical control group, without blinding and randomization, on 60 patients
Settings and conduct
For 30 intubated patients referred to the emergency department of Yazd Shahid Sadoughi Hospital who have inclusion criteria, Epinephrine is injected through a peripheral vein, until SBP raise to 90 mm of mercury or MAP raise to 65 mm of mercury. If side effects occur, Epinephrine will be discontinued.
Participants/Inclusion and exclusion criteria
Inclusion criteria is age more than 14 and less than 65; systolic blood pressure (SBP) less than 90 mm of mercury or mean arterial pressure (MAP) less than 65 mm of mercury.
Exclusion criteria is pregnancy and heart rate more than 180 beat per minute.
Intervention groups
We will choose 30 patient for case group from intubated patients referred to the emergency department of Yazd Shahid Sadoughi Hospital. For these patients Epinephrine will be injected every two minutes until SBP raise to 90 mm of mercury or MAP raise to 65 mm of mercury,
30 patients in control group will be selected from patients who had inclusion and exclusion criteria, and were intubated 1 years ago in the emergency department of Yazd Shahid Sadoughi or Shahid Rahnemoun Hospital.
Main outcome variables
Systolic and diastolic blood pressure; heart rate; receiving vasoactive drug in the first 24 hours (Epinephrine or other drugs); side effects of Epinephrine injection; mortality rate in the first 24 hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200809048341N2
Registration date:2020-12-10, 1399/09/20
Registration timing:prospective
Last update:2020-12-10, 1399/09/20
Update count:0
Registration date
2020-12-10, 1399/09/20
Registrant information
Name
Soheila Azimi Aabarghouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3828 2682
Email address
s.azimi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of push dose Epinephrine on mortality rate following intubation in hypotensive patients
Public title
Effect of Epinephrine in treatment of hypotension of intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
systolic blood pressure lesser than 90 mmHg or mean arterial pressure lesser than 65 mmHg
Exclusion criteria:
pregnancy
heart rate more than 180 beat per minute
Age
From 14 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of school of medicine _ shahid sadoughi university of medical sciences
Street address
Central building of Shahid Sadoughi university of medical sciences, Bahonar square, Yazd
City
Yazd
Province
Yazd
Postal code
89416978477
Approval date
2019-08-27, 1398/06/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.022
Health conditions studied
1
Description of health condition studied
mortality following intubation in hypotensive patients
ICD-10 code
T88.4XXA
ICD-10 code description
Failed or difficult intubation, initial encounter
Primary outcomes
1
Description
Percentage of people whose systolic blood pressure reaches above 90 mm of mercury or mean arterial pressure reaches above 65 mm of mercury after epinephrine administration.
Timepoint
30 minutes before until 1 hour after intubation when the patient has a systolic blood pressure less than 90 mm of mercury or a mean arterial pressure less than 65 mm of mercury.
Method of measurement
Mercury sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For 30 patients who have SBP less than 90 mm of mercury or MAP less than 65 mm of mercury in 30 minutes before to 1 hour after intubation, a push dose of Epinephrine at a concentration of 1/100000 at 1cc every 2 minutes will be injected to the peripheral vessel until SBP become above 90 or MAP become above 65 mm of mercury. In addition, patients' blood pressure will be checked manually with a Mercury sphygmomanometer. Vital signs are measured and recorded 30 minutes before intubation and then every 15 minutes to 1 hour after intubation and at the end of 24 hours. If the side effects of Epinephrine happened, the administration will be discontinued.
Category
Treatment - Drugs
2
Description
Control group: The control group will be selected from 30 patients who underwent intubation in the emergency department of Yazd Shahid Sadoughi or Shahid Rahnemoun Hospital one year before the start of the study and met the inclusion and exclusion criteria. If these patients have a defective record, they will be removed from the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Soheila Azimi Abarghouei
Street address
Emergency Department, Ebne Sina Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3828 2682
Email
S.azimi@ssu.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Rahnemoon Hospital
Full name of responsible person
Soheila Azimi Abarghouei
Street address
Farrokhi St, Yazd
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3828 2682
Email
S.azimi@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Masoud Mirzaei
Street address
Central building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3724 0171
Email
Info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Mohammadi Hanzaie
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Dead End 22, Naeem Abad St., Kashani St.
City
Yazd
Province
Yazd
Postal code
8916768759
Phone
+98 35 3824 9596
Email
frozenfsm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Soheila Azimi Aabarghouei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency ward, Shahid Sadoughi Hospital, Ebne sina Blvd.
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3828 2682
Email
S.azimi@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Mohammadi Hanzaie
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Dead End 22, Naeem Abad St., Kashani St.
City
Yazd
Province
Yazd
Postal code
8916768759
Phone
+98 35 3824 9596
Email
frozenfsm@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available