The effect of implementing prevention of Central Line Associated Blood Stream infection bundle on the incidence of this infection in patients admitted to intensive care units
Identification of the effect of implementing a care bundle for prevention of blood infection related to central venous catheter on the incidence of this infection in patients admitted to intensive care units of Namazi Hospital- Shiraz
This research will be performed in two intensive care units of Namazi Hospital. One of them will be randomly selected by tossing a coin as the intervention ward and the other will be selected as the control ward. These wards are similar in terms of type of patients and medical team and disciplines. In the control group, care of central venous catheter will be performed according to the hospital protocol .In the intervention group, beside following the hospital protocol, a care bundle including the use of transparent dressing and bionector connector, and early catheter removal in absence of clinical indication will be used.
Participants/Inclusion and exclusion criteria
*Inclusion criteria
-Admitted in general and central ICUs of Namazi hospital
-completion of the informed consent
-having central venous catheter
-having age18-80 years
*exclusion criteria
-Catheter removal less than 48 hours after placement
-Occurrence of symptoms of local infection or bloodstream infection associated with central venous catheter less than 48 hours after catheter placement
-Death of the patient
Intervention groups
In the intervention group, care of central venous catheter in patients who have the inclusion criteria, beside the performance of hospital protocols, will be done using bionector, transparent dressing, and supervising early catheter removal in absence of clinical indication.
In the control group, care of the selected patients, will be performed according to hospital protocols.
Main outcome variables
Incidence of blood infection associated with central venous catheter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160525028060N4
Registration date:2022-08-02, 1401/05/11
Registration timing:registered_while_recruiting
Last update:2022-08-02, 1401/05/11
Update count:0
Registration date
2022-08-02, 1401/05/11
Registrant information
Name
Fereshteh Dehghanrad
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3235 4285
Email address
dehghanrad@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of implementing prevention of Central Line Associated Blood Stream infection bundle on the incidence of this infection in patients admitted to intensive care units
Public title
The effect of implementing prevention of Central Line Associated Blood Stream infection bundle on the incidence of this infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Admitted in general and central ICUs of Namazi hospital
Completion OF the informed consent form
Having central venous catheter
having age between 18-80years
Exclusion criteria:
Catheter removal less than 48 hours after placement
Symptoms of local infection or bloodstream infection associated with central venous catheter less than 48 hours after catheter placement
Death of the patient
Transferring the patient from the intervention and control wards to other wards
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
340
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed with filliping the coin method in which one of two wards is selected as intervention group ward and the other is selected as control group ward according to be head or tails
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 Shiraz University of Medical Sciences
Street address
Zand BLVD,shiraz
City
Shiraz
Province
Fars
Postal code
123456
Approval date
2022-05-31, 1401/03/10
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1401.036
Health conditions studied
1
Description of health condition studied
Blood infection associated with central venous catheter
ICD-10 code
B99
ICD-10 code description
other infectious disease
Primary outcomes
1
Description
Incidence of blood infection associated with central venous catheter
Timepoint
During the intervention
Method of measurement
Blood culture
Secondary outcomes
1
Description
the length of ICU stay
Timepoint
until the end of time of Intensive Care Unit stay
Method of measurement
time: day
Intervention groups
1
Description
Intervention group: Patients in intervention group, in addition to receive hospital protocol about central catheter care, receive the prevention of catheter related blood stream infection care bundle including: the use of bionector connector for insuring closed system, use of transparent dressing for covering the insertion site, and supervising early catheter removal in absence of clinical indication.
Category
Prevention
2
Description
Control group: Patients in control group, receive care of central venous catheter according to the hospital protocol.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Dr Ahmad Hosseinzadeh
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
7193613119
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
Dr Sayyed Vahid Hosseini
Street address
Zand
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@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
Fereshteh Dehghanrad
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Namazi square,Zand street
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4257
Email
dehghanrad@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fereshteh Dehghanrad
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Namazi square, Zand street
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4257
Email
dehghanrad@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fereshteh Dehghanrad
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Namazi square, Zand street
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4257
Email
dehghanrad@sums.ac.ir
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
No - There is not 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