The effect of continuous infusion of Meropenem antibiotic in Clinical symptoms and Procalcitonin changes in sever sepsis
Design
This study is clinical trials and double blind.60 patients admitted to the intensive care unit of Valiasr Hospital in Arak were enrolled.
Settings and conduct
60 patients admitted to the intensive care unit of Valiasr hospital in Arak were enrolled.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-75 years; patients admitted to ICU with the diagnosis of evidence of infection and at least two of the symptoms of SIRS (sepsis)
Exclusion criteria: Incidence of drug-related complications; no response to treatment within 72 hours
Intervention groups
Immediately after the initial diagnosis patients in the intervention group (30), one gram of morophenem in one bolus and 100 milligram in hours of antibiotic maroponum, receive continuous infusion over a period of 72 hours.Placebo is injected every 12 hours as bolus.Patients in the control group (n = 30) received one gram of moropenum as bolus dosing every 12 hours and 10 cc per hour of normal saline for continuous infusion over a period of 72 hours.
Main outcome variables
The effect of continuous infusion of Meropenem antibiotic in Clinical symptoms and Procalcitonin changes in sever sepsis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N65
Registration date:2018-01-31, 1396/11/11
Registration timing:registered_while_recruiting
Last update:2018-01-31, 1396/11/11
Update count:0
Registration date
2018-01-31, 1396/11/11
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-20, 1396/02/30
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of continuous infusion of Meropenem antibiotic in Clinical symptoms and Procalcitonin changes in sever sepsis
Public title
The effect of continuous infusion of Meropenem antibiotic in Clinical symptoms and Procalcitonin changes in sever sepsis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-75 years
Patients admitted to ICU with the diagnosis of evidence of infection and at least two of the symptoms of SIRS (sepsis)
Exclusion criteria:
Incidence of drug-related complications
No response to treatment within 72 hours
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not aware of the treatment received.Participant and Analyzer are blind (double blind).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
At the time of arrival, 24, 48 and 72 hours after receiving the drug
Method of measurement
Glasgow scale
4
Description
Incidence of mortality
Timepoint
Before and 2 weeks after treatment
Method of measurement
Number
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: En Immediately after the initial diagnosis patients in the intervention group (30), one gram of morophenem in one bolus and 100 milligram in hours of antibiotic maroponum, receive continuous infusion over a period of 72 hours.Placebo is injected every 12 hours as bolus
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group (n = 30) received one gram of moropenum as bolus dosing every 12 hours and 10 cc per hour of normal saline for continuous infusion over a period of 72 .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Behnam Mahmodie
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street