]n this study, we have attempted to evaluate the effect of inhaled verapamil on oxygenation in Chronic obstructive pulmonary disease (COPD) patients under intensive care.
Design
Clinical trial with control parallelgroup , double-blind, randomized with odd and even numbers
The sample size is 40 patients. The implementation phase is 1-2.
Settings and conduct
This study is carried out in the intensive care unit of Dr. Masih Daneshvarihospital, ,
The amount of 10 mg of verapamil was administered as an inhaler to patients who had entered the design, and normal saline nebuliser was administered to patients who had entry criteria and in the placebo group. Except for the ICU resident physician, other elements of the plan include patients, those who collected the information, and the person analyzing the information are not aware of the groupings.
Participants/Inclusion and exclusion criteria
All ICU- admitted COPD patients of Masih Daneshvari Hospital , Tehran were collected
those with
● Bradycardia
● Atrioventricular Block
● Cardiac muscle weakness due to amiodarone and other calcium blockers
● Concomitant use of digoxin
● Taking phenobarbital and phenytoin drugs
● Co-administration of β-adrenergic receptors blockers
● Patients with QT disorders
were excluded from the study.
Intervention groups
1. Verapamil
2- Placebo
Main outcome variables
Primary Outcomes:
- Arterial oxygen saturation
- Score of patients' shortness of breath
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170210032478N1
Registration date:2018-06-05, 1397/03/15
Registration timing:retrospective
Last update:2018-06-05, 1397/03/15
Update count:0
Registration date
2018-06-05, 1397/03/15
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2163
Email address
dr.f.ghorbani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-31, 1397/03/10
Expected recruitment end date
2018-08-01, 1397/05/10
Actual recruitment start date
2017-11-22, 1396/09/01
Actual recruitment end date
2018-04-09, 1397/01/20
Trial completion date
empty
Scientific title
The effect of verapamil nebulizer on oxygenation in COPD patients admitted to ICU
Public title
Verapamil effect on COPD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All ICU- admitted COPD patients
Exclusion criteria:
pregnancy
sever hepato renal dysfunction
AV block or arrythmia
EF less than 40%
verapamil hypersensitivity
beta-adrenergic receptor drugs
QT disorders in patients
Bradycardia
co- administration of Digoxin
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Using even and odd numbers , the patients are simply randomized and placed in two groups of intervention and placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to treat any possible complications, the physician who provide clinical care, is not blind. Other blind groups are as below:
Participants
Principal investigator
Data collection authorities
Outcome manager
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of National Research Institute of Tuberculosis and Lung Diseases
Street address
Niavaran, Daaraabaad
City
Tehran
Province
Tehran
Postal code
1956744413
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.sbmu.nritld.rec.1397.513
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J00-J99
ICD-10 code description
Diseases of the respiratory system
Primary outcomes
1
Description
Arterial Oxygenation Blood gaz
Timepoint
20 minutes after taking the medication or placebo for 3 days, Q 12 h
Method of measurement
Arterial Blood Gaz
2
Description
BORG scale
Timepoint
20 minutes after taking the medication or placebo for 3 days, Q 12 h
Method of measurement
Tacking History
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Inhalation of Verapamil
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Giti Pourdoulat
Street address
Daaraabaad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2163
Fax
+98 21 2610 5387
Email
dr.f.ghorbani@sbmu.ac.ir
Web page address
http://www.nritld.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Dr. Parisa Farnia
Street address
Daaraabaad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2009
Email
tdrc.nritld@yahoo.com
Grant name
14200
Grant code / Reference number
14200
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Research Institute of Tuberculosis and Lung Diseases
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
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Fariba Ghorbani
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 1,Daraabaad Ave., Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2163
Fax
+98 21 2610 5387
Email
dr.f.ghorbani@sbmu.ac.ir
Web page address
http://www.nritld.sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Giti Powrdoulat
Position
Assistant Proffessore
Latest degree
Subspecialist
Other areas of specialty/work
pulmonology
Street address
Daraabaad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2163
Email
tdrc.nritld@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Behrooz Frzanegan
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Intensivist
Street address
Daraabaad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956744413
Phone
+98 212712537
Email
farzaneganbehrooz@gmail.com
Web page address
http://www.sbmu.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