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Pro-inflammatory cytokine profile of intubated patients following nebulization of hypertonic saline as prophylaxis of VAP

Protocol summary

Summary
As study of effect of nebolization of hypertonic saline 5% in intubated patients for prevention of ventilatory associated pneumonia, in a randimized controlled double blind clinical trial,30 patients, 20-60 yr, male and female, divided to two groups, intervention group, nebolization NaCl5% (n=15), control group, sterile water (n=15). Inclusion criteria: intubation period less than 24 hour, no clinical and imaging manifestation of pneumonia exclusion criteria: pulmonary infection; Acute physiology and chronic health evaluation II score II>25; active infection in admission; evidence of infection in chest X ray; immune deficiency; prescribe of high dose cortocosteroid (more than 300mg hydrocortisone); advanced cancer. In intervention group hypertonic saline% ,7 ml and in control group water sterile, 7 ml, will be nebolized until extubation or for 7 days each 6 hour., Before start of study (phase 0) and 48, 72, 120 and 144 hour sample of tracheal secretions and blood will be provided for microbial smear and culture and Interlukin-6. Potassium,Sodium, blood gas analysis, blood suger, blood urea, Creatinin, hemoglubin, hematocrit,Acute Physiology And Chronic Health Evaluation II score, Simlified clinical Pulmonary Infectious score will be meassured and recorded. we will record age, gender, cause of ICU addmision and comorbidity too.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202169045N1
Registration date: 2015-09-01, 1394/06/10
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-01, 1394/06/10
Registrant information
Name
Mohammad Taghi Beigmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2511
Email address
beigmohammadi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-19, 1394/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pro-inflammatory cytokine profile of intubated patients following nebulization of hypertonic saline as prophylaxis of VAP
Public title
inflammatory profile following nebulization of hypertonic saline as prophylaxis of VAP
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: intubation period less than 24 hour, no clinical and imaging manifestation of pneumonia exclusion criteria: pulmonary infection; Acute physiology and chronic health evaluation II score II>25; active infection in admission; evidence of infection in chest X ray; immune deficiency; prescribe of high dose cortocosteroid (more than 300mg hydrocortisone); advanced cancer.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Teran, Keshavarz st., forward of ghods st.
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
90-02-30-11653-42368

Health conditions studied

1

Description of health condition studied
Ventilatory Associated Pneumonia
ICD-10 code
J67-J70
ICD-10 code description
Aspiration pneumonia (due to): NOS, food, (regurgitated) gastric secretions, milk, vomit

Primary outcomes

1

Description
pneumonia
Timepoint
0, 48, 72, 120 and 144 hour after start of study.
Method of measurement
physical exam,chest x ray, culture of tracheal secretion

Secondary outcomes

1

Description
level of Interlukin- 6 levelof trachea secretions and blood
Timepoint
0, 48,72,120 and 144 hour after start of study
Method of measurement
ELIZA

Intervention groups

1

Description
in intervention group 7 ml hypertonic saline 5% and in control group 7 ml sterile water will be nebulized each 6 hours until the extubated or maximum for 7 days. The patients will be followed for 28 days and 28 days mortality rate will record.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex ICUs
Full name of responsible person
Dr. Mohammad Taghi Beigmohammadi
Street address
Imam Khomeini Hospital Complex
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyed Ahmad Rezaii
Street address
Keshavarz street, edge of ghods street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Taghi Beigmohammadi
Position
Assisstant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6119 2511
Fax
Email
beigmohammadi@tums.ac.ir - mbage46@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohmmad Taghi Beigmohammadi
Position
Assisstant Professor
Other areas of specialty/work
Street address
Tehran
City
tehran
Postal code
Phone
+98 21 6119 2511
Fax
Email
mbage46@ gmail.com - beigmohammadi@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Taghi Bbeigmohammadi
Position
Assisstant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Tehran
Postal code
1419733141
Phone
+98 21 6119 2511
Fax
+98 21 6693 5226
Email
mbage46@gmail.com - beigmohammadi@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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