Objectives :Considering the importance and prevalence of ventilator-induced pulmonary infections in intensive care unit (ICU) patients, in this study we review the effect of adding inhaled colistin for the treatment of ventilator-associated pulmonary infection in ICU patients.Design: This study is a randomized controlled clinical trialincontrol and case groups. Method: The candidate patients with ventilator-induced pulmonary infections are randomly assigned to either placebo or interventional group.In the intervention group, patients received 150 mg colistin plus 1,000,000 unit nebula every eight hours and the control group received only 300 mg every eight hours. Using clinical pulmonary infection score(CPIS),patients are followed up for seven days after the initial diagnosis in terms of clinical findings such as body temperature, white blood cell count, pulmonary secretion culture, and chest radiograph status. Inclusion criteria: This study performed on 114 patients with ventilator-induced pulmonary infections (VAP) admitted to the ICU of Rasoul-e-Akram Hospital Complex after obtaining informed consent. Patients over 16 years of age entered the study with multi-drug resistant (MDR) Acinetobacter, positive culture and without sensitivity to polymyxins. Exclusion criteria: Patients were excluded due to death, having sensitivity to polymexin, a decrease in GFR of <0.25 or the occurrence of evidence of bronchospasm in the intervention group.Main outcome measures: The response to treatment is considered fornormalization of all CPIS criteria and improving the CPIS score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091236068N1
Registration date:2017-11-15, 1396/08/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-15, 1396/08/24
Registrant information
Name
Behnam Mahmoudyeh
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2675 8928
Email address
b.mahmodie@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
There was no funding source in this study.
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Inhaled Colistin on the Treatment of Pulmonary Infections Caused by Ventilator with Multi-drug Resistant Acinetobacter
Public title
Effect of Inhaled Colistin on the Treatment of Pulmonary Infections Caused by Ventilator with Multi-drug Resistant Acinetobacter at in Intensive Care Unit of Rasoul-Akram Hospital in 2016-17
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age ranging: over 16 years; multi-drug resistant patients especially multidrug-resistant Acinetobacter; without sensitivity to polymyxins; positive culture (Colony count: BAL 104 or Mini BAL 105). Exclusion criteria: patient death; incidence of sensitivity to polymyxins; reduced GFR <0.25; incidence of bronchospasm evidences in treatment group.
Age
From 16 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
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 Iran University of Medical Sciences
Street address
Ethics Committee of Iran University of Medical Sciences, Iran University of Medical Sciences, Hemmat Highway, Tehran, Tehran Province
City
Tehran
Postal code
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9211384201
Health conditions studied
1
Description of health condition studied
Pulmonary infection Caused by Ventilator
ICD-10 code
A31.0
ICD-10 code description
Pulmonary mycobacterial infection
Primary outcomes
1
Description
The severity of pulmonary infection using CPIS
Timepoint
At the first, third and seventh days after intervention
Method of measurement
Using Clinical Pulmonary Infection Score (CPIS) Calculator; CPIS more than 6 at baseline or at 72 h: pneumonia; CPIS less or equal to 6 at 72 hours patient: without pneumonia
Secondary outcomes
empty
Intervention groups
1
Description
In treatment group, patients received administrated 150 mg of intravenous colistin in addition to 1000000 units inhaled colistin for one week every eight hours.
Category
Treatment - Drugs
2
Description
The control group only received 300 mg of colistin every eight hours intravenously for one week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-e-Akram hospital
Full name of responsible person
Dr Behnam Mahmoudyeh
Street address
Rasoul-e-Akram hospital, Satarkhan St, Tehran, Tehran Province
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology of Iran University of Medical Sciences
Full name of responsible person
Dr Sayed Ali javad Mousavi
Street address
Vice chancellor for Research and Technology of Iran University of Medical Sciences, Iran University of Medical Sciences, Hemmat Highway, Tehran, Tehran Province
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 and Technology of Iran 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
Arak University of Medical sciences , Iran
Full name of responsible person
Dr Behnam Mahmoudyeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, Valiasr Hospital, ValiAsr Square, Arak
City
Arak
Postal code
Phone
+98 21 2675 8928
Fax
Email
behnammahmoudye@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical sciences , Iran
Full name of responsible person
Dr Behnam Mahmoudyeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, Valiasr Hospital, ValiAsr Square, Arak
City
Arak
Postal code
Phone
+98 21 2675 8928
Fax
Email
behnammahmoudye@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical sciences , Iran
Full name of responsible person
Dr Behnam Mahmoudyeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, Valiasr Hospital, ValiAsr Square, Arak
City
Arak
Postal code
Phone
+98 21 2675 8928
Fax
Email
behnammahmoudye@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)