Comparison of High Doses of Meropenem with its Usual Dose in increasing the effect of Cholestine on the treatment of ventilator-dependent pneumonitis resulting from Acintobacter
Comparison of the effectiveness of high dose of meropenem with its usual dose in increasing the effect of cleistine on the treatment of ventilator-dependent pneumonia caused by Acinetobacter
Design
The study was a double-blind clinical trial in two intervention groups (continuous infusion of 250 mg per hour) and a control group (one gram every 8 hours) with a sample size of 60 people over 6 months.
Settings and conduct
The study is a double-blind clinical trial in the ICU of Imam Hossein Hospital in Tehran.
Participants/Inclusion and exclusion criteria
1. Age over 18 years
2. Having at least two VAP(Ventilation Associated Pnemunea) criteria
Intervention groups
The intervention group will be given a 250 mg dose of Meropenem ampule by continuous infusion with a pump. The control group will be given an intravenous dose of Meropenem ampule at a usual dose of 1000 mg every 8 hours. Both will be routinely treated with coeistine. Evaluation of VAP(Ventilation Associated Pnemunea) criteria will be performed daily in both groups and the response to the drug in both intervention and control groups will be compared. The study is double blind. The medicine is prescribed by a doctor and injected and recorded by a nurse. The samples will be analyzed by the center's laboratory expert. The interpretation of the data will be done by the researcher and will be decided based on the interpreted results.
Main outcome variables
Ventilator Associated Pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210405050848N1
Registration date:2021-06-07, 1400/03/17
Registration timing:registered_while_recruiting
Last update:2021-06-07, 1400/03/17
Update count:0
Registration date
2021-06-07, 1400/03/17
Registrant information
Name
Jafar Vakili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 5720
Email address
jafar.vakili@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of High Doses of Meropenem with its Usual Dose in increasing the effect of Cholestine on the treatment of ventilator-dependent pneumonitis resulting from Acintobacter
Public title
Pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Having at least two VAP criteria (increase in WBC above 11000 and decrease in WBC below 4000, fever above 38.5, culture of pulmonary secretions sensitive to cleistine, changes in CXRay)
Exclusion criteria:
History of allergy to Meropenem
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the participants according to the inclusion criteria, the pretest was performed using a ventilator-dependent pneumonia evaluation checklist, then randomly assigned by the head nurse based on blocking. Given that 60 people had to be included in the study and there were two groups (intervention and control), taking into account all possible possibilities, 6 blocks of 4 states were calculated (it is necessary to explain that the number of blocks of the combination formula : C (n , r)= C_r^n=n C r=(n¦r) was obtained).
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blind. The drug is prescribed by a physician and injected by a nurse and recorded in a checklist. The patient and the researcher have no role in randomly assigning the samples to the intervention or control group, and the intervention will be performed and the results will be recorded by the relevant nurse. The samples will be analyzed by the center's laboratory expert. The interpretation of the data will be done by the researcher and will be decided based on the interpreted results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
Street address
th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-03-06, 1399/12/16
Ethics committee reference number
IR.SBMU.MSP.REC.1399.772
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
VAP (Ventilation Associated Pneumonia)caused by Acinetobacter
Timepoint
Before and 3 day After intervention
Method of measurement
VAP(Ventilation Associated Pneumonia) criteria
Secondary outcomes
1
Description
control of ventilator associated pneumonia
Timepoint
Before and 3 days after intervention
Method of measurement
VAP (Ventilation Associated Pneumonia) criteria
Intervention groups
1
Description
Intervention group: Continuous infusion of Meropenem(The intervention group will be given a 250 mg dose of Meropenem ampule as a continuous infusion with a pump, and routine infusion of Cleistine will continue in ventilator-associated pneumonia.)
Category
Treatment - Drugs
2
Description
Control group: Infusion each 8 hours of Meropenem (The control group will receive an intravenous infusion of Meropenem at a dose of 1000 mg every 8 hours. Routine infusion of Cleistine will continue in ventilator-associated pneumonia.)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hosein Hospital
Full name of responsible person
Jafar Vakili
Street address
Emam Hossein Hosp. Madani St. Tehran Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Fax
+98 21 23871
Email
jafar.vakili@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zargi
Street address
7th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Fax
+98 21 2243 9770
Email
jafar.vakili@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jafar Vakili
Position
Fellowship of ICU
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
7th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
jafar.vakili@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jafar Vakili
Position
Fellowship of ICU
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
7th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
jafar.vakili@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jafar Vakili
Position
Fellowship of ICU
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
7th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
jafar.vakili@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD