Evaluation of the effect of enteral administration of glutamine supplement for the prevention of ventilator associated pneumonia in critically ill patients
Evaluation of the effect of enteral administration of glutamine supplement for the prevention of ventilator associated pneumonia in critically ill patients
Design
Randomized clinical trial with a parallel group was designed among 40 patients (20 patients in each glutamin and control group). Simple randomization was used to allocate patients to these 2 groups.
Settings and conduct
This randomized, clinical trial was designed to evaluate the effect of the enteral glutamin on the prevention of ventilator associated pneumonia among 40 patients, in two parallel groups. Patients were randomly allocated to glutamin and control group. In intervention group, in addition to standard prevention strategies, 40 gram oral powder of glutamin was administered daily for 7 days. But, in control group only standard prevention strategies were conducted. All patients were followed daily for occurrence of ventilator associated pneumonia base on CPIS criteria for 14 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Adult patients undergoing mechanical ventilation for 48 hours
Exclusion criteria:
Diagnosis of acute respiratory distress syndrome or Pneumonia at intensive care unit (ICU) admission
Intervention groups
Intervention group: In addition to standard prevention strategies, forty milligram of glutamin powder was administered via enteral rout, for 7 days.
Control group: Only standard prevention strategies were conducted.
Main outcome variables
Score calculated based on clinical pulmonary infection score (CPIS) table
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150221021159N5
Registration date:2020-06-30, 1399/04/10
Registration timing:registered_while_recruiting
Last update:2020-06-30, 1399/04/10
Update count:0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
Shadi Farsaei
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2618
Email address
farsaei@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of enteral administration of glutamine supplement for the prevention of ventilator associated pneumonia in critically ill patients
Public title
The effect of enteral administration of glutamine supplement for the prevention of ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients undergoing mechanical ventilation for 48 hours
Exclusion criteria:
Diagnosis of acute respiratory distress syndrome or Pneumonia at intensive care unit (ICU) admission
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Glutamin and control group were written in 2 separated cards and placed in the box. One of these 2 cards was randomly selected when each patient was recruited to the study, and patient was allocated to glutamin or control group, based on selected card.
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 Isfahan University of Medical Sciences
Street address
Bldg No. 4, Isfahan University of Medical Sciences and Health Services, Hizar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-07-09, 1398/04/18
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.215
Health conditions studied
1
Description of health condition studied
Ventilator associated pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
Prevention of ventilator associated pneumonia
Timepoint
Evaluation of the occurrence of ventilator associated pneumonia daily, during 14 days after study recruitment
Method of measurement
Calculate the clinical pulmonary infection score (CPIS) table
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Forty milligram of glutamin powder was administered via enteral rout, for 7 days.