Evaluation efficacy of Tadalafil and Bosentan on pulmonary arterial pressure, cardiac outupt and prognosis of mechanical ventilation in COPD patients with pulmonary hypertenion under mechanical ventilation
Evaluation efficacy of Tadalafil and Bosentan on pulmonary arterial pressure, cardiac outupt and prognosis of mechanical ventilation in COPD patients with pulmonary hypertenion under mechanical ventilation
Design
This study is a randomized clinical trial with parallel groups without blinding and phase 2-3. Patients admitted to the intensive care unit after random allocation will be divided into two groups
Settings and conduct
In this study, which will be performed in the intensive care unit of Imam Reza Hospital (Tabriz), 100 patients will be included in the study and will receive the intervention after random allocation. Bosentan will be given 125 mg twice daily and Bosadant 40 mg once daily, and finally lung tests will be measured and compared.
Participants/Inclusion and exclusion criteria
After entering the study, patients will be divided into two groups: Bosentan and Tadalfil using a random number table. Randomization list by assigning B and T codes to the two groups of Bosentan tablets (twice daily) and Tadalfil tablets (once daily) and with the help of the website https://www.sealedenvelope.com/simple-randomiser/v1 / lists will be done.
Intervention groups
After randomly assigning patients to two groups, Bosentan will be given 125 mg twice daily for the bosentan group and 40 mg once daily for the tadalfil group; Before and after the intervention, the impact volume, left ventricular and pulmonary artery pressure will be measured and compared.
Main outcome variables
Pulmonary function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N24
Registration date:2021-10-14, 1400/07/22
Registration timing:prospective
Last update:2021-10-14, 1400/07/22
Update count:0
Registration date
2021-10-14, 1400/07/22
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-21, 1400/08/30
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation efficacy of Tadalafil and Bosentan on pulmonary arterial pressure, cardiac outupt and prognosis of mechanical ventilation in COPD patients with pulmonary hypertenion under mechanical ventilation
Public title
Tadalafil and Bosentan on pulmonary arterial pressure, cardiac outupt and prognosis of mechanical ventilation in COPD patients with pulmonary hypertenion under mechanical ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of COPD
Hospitalized in the pulmonary intensive care unit
Under controlled breathing or connected to a ventilator
Exclusion criteria:
Body mass index higher than 30
Lung cancer and any other type of cancer
Right and left ventricular dysfunction
Chest radiotherapy during the last month
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the study, patients will be divided into two groups: Bosentan and Tadalfil using a random number table. Randomization list by assigning B and T codes to the two groups of Bosentan tablets (twice daily) and Tadalfil tablets (once daily) and with the help of the website https://www.sealedenvelope.com/simple-randomiser/v1 / lists will be done.
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
Ethics committee of Tabriz University of Medical Sciences
Intervention group 1: Patients will be treated with the available drugs for three weeks, so that patients in the Bosentan group will receive 125 mg of the drug twice a day.
Category
Treatment - Drugs
2
Description
Intervention group 2: For patients in the tadalafil group, this drug will be given at a dose of 40 mg once a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Khalil Ansarin
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 41 3335 5921
Email
Dransarin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohsen Pishbin
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Pishbin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@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