Protocol summary

Study aim
Determination and comparison of the effects of oral medroxyprogesterone and oral donepezil on improving respiratory status and facilitating mechanical ventilation discontinuation in patients undergoing mechanical ventilation in intensive care units
Design
Patients will be randomly divided into 3 groups receiving 10 mg daily Denepezil or MP or placebo randomly divided by permissive block method and will use their own medicine once a day for 10 days. Therefore, demographic and clinical data of registered patients, as well as medication history, clinical profiles, GCS and Sophia Score are reported.
Settings and conduct
Intensive care units of Dr. Rahnemoon Hospital of Yazd
Participants/Inclusion and exclusion criteria
Mechanical ventilation through endotracheal tube for at least 24 hours, oxygen saturation greater than 90%, FIO2 less than 50% and PEEP less than 8 cm water, hemodynamic stability over the past 12 hours, sedation withdrawal or sedation reduction Over the past 48 hours, neurological status stability with Ramsay's score was less than 5 and body temperature between 36 and 39 degrees. Exclusion criteria would be pregnancy or lactation, under 18 years of age, known allergy to donepezil or medroxyprogesterone, tracheostomy,Any hemodynamic instability, need to be obtained Sedation or unconsciousness, concurrent administration of potentially breathing stimulants such as doxapram and medroxyprogesterone, hypothyroidism
Intervention groups
One group is the Medroxy Progesterone recipient, the other is Donepezil and the last is the placebo recipient.
Main outcome variables
Mortality rate, duration of ventilation, length of stay in intensive care unit and hospital, clinicalstatus of patients, hospital discharge, scorpion sofa and GCS.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190810044500N2
Registration date: 2020-04-01, 1399/01/13
Registration timing: registered_while_recruiting

Last update: 2020-04-01, 1399/01/13
Update count: 0
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Fatemeh Saghafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
f.saghafi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-21, 1398/09/30
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effects of oral medroxyprogesterone and donepezil in improvement of respiratory status and facilitation in weaning of mechanical ventilation in patients undergoing mechanical ventilation in ICUs of Shahid Dr. Rahnemoon Yazd
Public title
Evaluation of effects of oral medroxyprogesterone and donepezil in improvement of respiratory status and facilitation in weaning of mechanical ventilation in patients undergoing mechanical ventilation in ICUs
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mechanical ventilation through endotracheal tube for at least 24 hours oxygen saturation greater than 90% FIO2 less than 50% PEEP less than 8 cm water hemodynamic stability over the past 12 hours sedation withdrawal or sedation reduction Over the past 48 hours neurological status stabilized with Ramsay's score less than 5 temperature between 36 and 39 degrees
Exclusion criteria:
Pregnancy or lactation under 18 years of age tracheostomy hepatic encephalopathy cerebral edema acute hydrocephalus myasthenia gravis Acute polyneuropathy lack of decision to discontinue respiratory support prolonged cardiac arrest with poor neurologic prognosis coincident extubation with day one acute right ventricular failure renal failure plasma urea exceeding (25 mol / L), Plasma creatinine greater than (180 mol / min) or creatinine clearance less than 30 ml / min, or more than 25% increase in creatinine over the past 24 hours contrast injection over the past six hours Serum sodium level greater than (150 m Eq) / L serum potassium level less than 3.5 (m Eq) / L metabolic alkalosis with arterial pH greater than 7.5 need for sedation or unconsciousness concurrent administration of drugs Potential respiratory stimulants such as doxapram and medroxyprogesterone hypothyroidism Known allergy to donepezil or medroxy progesterone
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The three drugs Donepezil and Medroxyprogesterone and placebo were named in letters A, B and C. The order of prescribing of medications to the specimens was determined using a random number table
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blindness was performed on clinical caregivers, including physicians and nurses, as well as variables assessors and data analysts.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
faculty of ethics of medical sciences - shahid sadoughi university of medical sciences
Street address
Gomnam shohada boulevard - shahid sadoughi university of medical sciences
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2019-11-11, 1398/08/20
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.198

Health conditions studied

1

Description of health condition studied
weaning of mechanical ventilation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
blood gas includes PO2, PCO2, PHCO3, O2 saturation and PH
Timepoint
Before intervention and one day after and after weaning of mechanical ventilation
Method of measurement
blood sample

2

Description
hemoglobin
Timepoint
Before intervention and one day after and after weaning of mechanical ventilation
Method of measurement
blood sample

3

Description
level of consciousness
Timepoint
Before intervention and one day after and after weaning of mechanical ventilation
Method of measurement
glass coma scale

4

Description
sofa score
Timepoint
Before intervention and one day after and after weaning of mechanical ventilation
Method of measurement
Scoring based on pulmonary, coagulation, hepatic, cardiovascular, central nervous system and renal status

Secondary outcomes

1

Description
duration of weaning
Timepoint
From the process of separation from the device to the patient's spontaneous breathing
Method of measurement
Counting the number of days

Intervention groups

1

Description
Intervention group:
Category
Treatment - Drugs

2

Description
Control group:
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Dr. Rahnemoon hospital Yazd
Full name of responsible person
Mohamad Hosein Dehghani
Street address
Farokhi street
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۹
Phone
+98 35 3626 0001
Email
Rahnemoonhospital@ssu.ac.ir
Web page address
https://web.ssu.ac.ir/index.aspx?lang=1&sub=4

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohamad Reza Mirjalili
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 1171
Fax
+98 35 3724 0371
Email
ravabet@SSU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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 Saghafi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Blvd., Yazd Province, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۹
Phone
+98 35 3820 3419
Fax
Email
F.saghafi@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Saghafi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Blvd., Yazd Province, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۹
Phone
+98 35 3820 3419
Fax
Email
F.saghafi@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Saghafi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Blvd., Yazd Province, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۹
Phone
+98 35 3820 3419
Fax
Email
F.saghafi@ssu.ac.ir

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
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