Protocol summary

Study aim
The effectiveness of taurine in reducing the incidence of ventilator-associated pneumonia in children under mechanical ventilation pediatric's intensive care unit of Namazi Hospital, Shiraz: a randomized, double-blind clinical trial.
Design
A randomized clinical trial with the control group, with parallel groups, double-blind, phase 3 on 72 patients. A table of random numbers was used for randomization.
Settings and conduct
In this study, randomization is done using a table of random numbers. In a ratio of one to one, one group receives taurine 30 mg/kg in two divided doses and another group gets a placebo 30 mg/kg in two divided doses of carboxymethyl Cellulose is given. All patient information is recorded and analyzed after collection. This study will be conducted in Namazi Hospital affiliated with Shiraz University of Medical Sciences, Shiraz, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all children from 3 months to 15 years who need mechanical ventilation for more than 48 hours and the completion of the ethical consent form by their parents, exclusion criteria before randomization: malignancy, AIDS, patients with heart failure, age Less than three months, Cystic fibrosis patients
Intervention groups
Patients are randomly divided into two receiving groups: taurine or placebo (carboxymethyl cellulose) orally from the time of intubation until the patients are hospitalized in the PICU department.
Main outcome variables
The incidence rate of ventilator-associated pneumonia, The incidence of septic shock

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120731010453N4
Registration date: 2023-06-29, 1402/04/08
Registration timing: prospective

Last update: 2023-06-29, 1402/04/08
Update count: 0
Registration date
2023-06-29, 1402/04/08
Registrant information
Name
Mojtaba Shafiekhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4255
Email address
mshafikhan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of taurine in reducing the incidence of ventilator-associated pneumonia inchildren undergoing mechanical ventilation in the pediatric intensive care unit of Shiraz Namazi Hospital arandomized, double-blind clinical trial
Public title
The effect of taurine in reducing the incidence of ventilator-associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and complete the ethical consent form by the parents. All children aged 3 months to 15 years who need mechanical ventilation for more than 48 hours.
Exclusion criteria:
Malignancy, AIDS Patients with heart failure Age less than three months Cystic fibrosis patients
Age
From 3 months old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 72
More than 1 sample in each individual
Number of samples in each individual: 36
36 patients are in the intervention group (taurine) and 36 patients are in the control group (placebo).
Randomization (investigator's opinion)
Randomized
Randomization description
All patients are randomly divided into two groups receiving taurine supplements or placebo by permutation blocking method. Quadruple permutation block randomization: All possible blocks are arranged as follows: Block 1: Block ABAB 2: Block AABB 3: Block ABBA 4: Block BBAA 5: Block BABA 6: BAAB We need 18 blocks to select 72 people. We choose these blocks randomly from numbers 1 to 6. For example, if number 6 is chosen as the first block and number 2 is chosen as the second block, the people entering the study will be given BAABAABB in that order. Finally, group A receives placebo and group B receives taurine.
Blinding (investigator's opinion)
Double blinded
Blinding description
In our study, the participants (patients) and the researcher do not know whether each patient received taurine or placebo. Taurine and placebo are both prepared in the form of 250 mg capsules with the same shape, color, and size and in the same packaging. Only one of the colleagues, who does not have a role in evaluating the results and analyzing the data, knows about the division of patients based on the table of random numbers.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz, Zand Ave, Central building of Shiraz University of medical sciences.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2023-06-24, 1402/04/03
Ethics committee reference number
IR.SUMS.REC.1402.149

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
The incidence of ventilator-associated pneumonia
Timepoint
During the intubation period of the patient in the intensive care unit
Method of measurement
Based on the criteria of ventilator-associated pneumonia (doctor's clinical suspicion, patient's tests, patient's radiograph, and culture results)

Secondary outcomes

1

Description
The incidence of septic shock
Timepoint
As long as the patient is in the intensive care unit
Method of measurement
Diagnosis and confirmation by the doctor

Intervention groups

1

Description
Intervention group: Patients receive taurine in the amount of 30 mg/kg in the form of 250 mg capsules (in two divided doses) (from Allmax Nutrition Company) until they are hospitalized in the intensive care unit.
Category
Treatment - Drugs

2

Description
Control group: Patients receive 30 mg/kg carboxymethyl cellulose in the form of 250 mg capsules (in two divided doses) (from Merck Company) until they are hospitalized in the intensive care unit.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Nasrin Shirzad yazdi
Street address
Zand Ave, Namazi Square, Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
nemazee_inf@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Hashempour
Street address
Zand Street, Central Building, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3242 4127
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Shirzad yazdi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Abiverdi Ave, chamran Blvd
City
shiraz
Province
Fars
Postal code
7194733681
Phone
+98 71 3627 0861
Email
ny.shirzad@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Shirzad yazdi
Position
residency
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shiraz, Rokn Abad, Karabehan St
City
shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4127
Email
ny.shirzad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Shirzad yazdi
Position
residency
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shiraz, Rokn Abad, Karabehan St
City
shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4127
Email
ny.shirzad@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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