The effect of endotracheal administration of N-acetylcysteine and heparin on symptom improvement in acute respiratory distress syndrom and lung contusion
Determination of the Effect of Intracerebellar N-acetylcysteine and Heparin on the Improvement of Symptoms of Acute Respiratory Syndrome and Lung contusion
Design
In clinical trial phase 3,sigle blind, random allocation. 104 patients with inclusion criteria are divided into two groups.The first group receive only ICU routine treatments with 10 mililitr saline and the control group receive 500 units of heparin every four hours and 200 mg of acetylcysteine Soluble in 10 mililitr every 4 hours by intratracial.
Settings and conduct
Clinical trial study;Hajar Hospital, single blind and blindness of the research is from the side of the investigator and the investigator does not know the type of drug used for the patient
Participants/Inclusion and exclusion criteria
Inclusion criteria:patients with Acute Respiratory Distrees Syndrom and lung cantusion
Exclusion criteria: pregnancy; allergy to heparin or acetylcysteine
; active bleeding
Intervention groups
The first group receive only ICU routine treatments with 10 mililitr saline every 4 hours 1 times in the form of intratracial injection and the control group receive 500 units of heparin every four hours and 200 mg of acetylcysteine Soluble in 10 mililitr salin every 4 hours by intratracial.
Main outcome variables
Impoovement of respiratory signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190205042631N1
Registration date:2019-02-28, 1397/12/09
Registration timing:registered_while_recruiting
Last update:2019-02-28, 1397/12/09
Update count:0
Registration date
2019-02-28, 1397/12/09
Registrant information
Name
Hamid Roohi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 8891
Email address
hamidroohi123@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of endotracheal administration of N-acetylcysteine and heparin on symptom improvement in acute respiratory distress syndrom and lung contusion
Public title
The effect of endotracheal administration of N-acetylcysteine and heparin on symptom improvement in acute respiratory distress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute respiratory distress syndrom and lung cantusion
Exclusion criteria:
Pregnancy
Allergy to heparin or acetylcysteine
Active bleeding
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
26
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The blindness of the research is from the side of the investigator and the investigator does not know the type of drug used for the patient
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Vice Chancellor of Research and Technology , Shahrekord University of Medical Sciences, Kashani Blvd, Shahrekord,Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718765
Approval date
2017-07-22, 1396/04/31
Ethics committee reference number
182.IR.SKUMS.REC.1396
Health conditions studied
1
Description of health condition studied
lung disorder
ICD-10 code
J98.9
ICD-10 code description
Respiratory disorder, unspecified
Primary outcomes
1
Description
Improvement of respiratory symptoms.
Timepoint
After seven days
Method of measurement
Checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receive 500 units of heparin every four hours and 200 mg of acetylcysteine dissolved in 10 mililitr every 4 hours by intratracial for 7days.
Category
Treatment - Drugs
2
Description
Control group: receive only ICU routine treatments with 10 mililitr saline every 4 hours 1 times in the form of intratracial injection for 7days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Hamid Rouhi
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, ParastarAvenue,Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8819819854
Phone
+98 38 3222 0016
Email
hamidroohi@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research and Technology Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Kamal Solati
Street address
Vice Chancellor of Research and Technology Shahrekord University of Medical Sciences, Kashani Blvd, Shahrekord,Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881954525
Phone
+98 38 3334 2414
Email
solati@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research and Technology Shahrekord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Hamid Rouhi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, ParastarAvenue,Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718761
Phone
+98 38 3222 0016
Email
hamidroohi@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hamid Rouhi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, ParastarAvenue,Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718758
Phone
+98 0383220016
Email
hamidroohi@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hamid Rouhi
Position
Hajar Hospital of Shahrekord University of Medical Sciences, ParastarAvenue,Shahrekord, Iran
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, ParastarAvenue,Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718758
Phone
+98 38 3222 0016
Email
hamidroohi@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
checklist information
When the data will become available and for how long
7days
To whom data/document is available
En Researchers working in academia and academia
Under which criteria data/document could be used
article
From where data/document is obtainable
journals
What processes are involved for a request to access data/document