Mechanical ventilatory support is a critical component in the management of patients with respiratory failure in intensive care units (ICU). Weaning from mechanical ventilation is paramount importance. The object of this study is to assess of the effect of inhalational Budesonide in time decreasing to weaning, in difficult weaning patients in ICU. In a randomized clinical trial, 120 patients in ICU were assigned to receive inhalatory Budesonide 0/5 mg/day or normal saline (control group), randomly. Intubated patients difficult to wean with duration of ICU stay less than 21 days, were included in the study. Patients with bronchiectasis, sepsis or Systemic Inflammatory Response Syndrome (SIRS) were excluded from the study.
The variables of the respiratory system including pressure support and dynamic compliance and Interleukin 8 (IL-8) and Tumor necrosis factor alpha (TNF-a) in bronchoalveolar lavage for comparison in tow groups were measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030920592N5
Registration date:2016-05-08, 1395/02/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-08, 1395/02/19
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
none
Expected recruitment start date
2014-01-28, 1392/11/08
Expected recruitment end date
2016-01-28, 1394/11/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Budesonide and saline use on the time of the weaning from Mechanical ventilation for patients in ICU
Public title
Comparison of Budesonide and saline on weaning from Mechanical ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: intubated patients difficult to wean; duration of ICU stay less than 21 days.
The exclusion criteria: patients with bronchiectasis, sepsis or Systemic Inflammatory Response Syndrome, pleural effusion, and Ventilator-Associated Pneumonia
Age
From 15 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this double blind study neither the patients, the experimenter were not aware of type of intervention.Randomized block design was used to random allocation of patients to two groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yemen Street,Shahid Chamran Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-10-30, 1392/08/08
Ethics committee reference number
SBMU1.REC.1392.48
Health conditions studied
1
Description of health condition studied
weaning of mechanical ventilation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Number of days of mechanical ventilation
Timepoint
In start of the study and after 5 days
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
intervention:Budesonide
This group received inhaler Budesonide 1 h before extubation and treatment continued up to 48 h after extubation. Patients underwent the therapy with budesonide at a dosage of 0/5 mg diluted in 4 cc of sterile water for 20 minutes.
Category
Treatment - Drugs
2
Description
control: Normal Saline
Normal Saline was administered intra venous at a dosage of 0.15 mg/kg, one hour before extubation. After extubation, the administration of normal saline continued at the same dosage every 12 hour for 48 hour.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Sadoughi, investigator
Street address
Shahid Beheshti University of Medical Sciences, Tabnak Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammadreza hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2610 9512
Fax
Email
iran.criticalcare@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammad reza hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2610 9512
Fax
Email
iran.criticalcare@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
seyed mohammad reza hashemian
Position
Associate Professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2610 9512
Fax
Email
iran.criticalcare@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)