Catheter related bacterial infections in convenient versus needle-less (Planecta®) intravenous infusion systems in Mofid Children Hospital pediatric-ICU
Intravenous catheter related infections are from critical infections in hospitals especially in pediatric-ICUs. Several benefits in addition to preventing intravenous catheter related infections are mentioned for Planecta® closed injection system (JMS Co., Ltd.). The aim of this study is to compare the frequency of intravenous catheter related infections in P-ICU patients admitted to Mofid Hospital (Tehran, Iran) using Planecta® or conventional injection systems. Inclusion/exclusion criteria are: age range of one month to 14 years, at least 24 hours staying in P-ICU. Patients will be randomly allocated to the interventions according to the beds which will be assigned to each intervention every other one. Primary outcome is any intravenous catheter related infection e.g. phlebitis and septicemia that will be diagnosed according to the scientific definitions run in the ward.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805122287N1
Registration date:2009-09-26, 1388/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-09-26, 1388/07/04
Registrant information
Name
Ahmad Reza Shamshiri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 9123
Email address
shamshiri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Representative of JMS co, in Iran
Expected recruitment start date
2007-01-21, 1385/11/01
Expected recruitment end date
2007-10-22, 1386/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Catheter related bacterial infections in convenient versus needle-less (Planecta®) intravenous infusion systems in Mofid Children Hospital pediatric-ICU
Public title
Catheter related bacterial infections in convenient versus needle-less (Planecta®) intravenous infusion systems in Mofid Children Hospital pediatric-ICU
Purpose
Prevention
Inclusion/Exclusion criteria
Age range of 1 month to 14 years, no limitation for gender, no limitation for underlying disease or cause of admission, at least 24 hours staying in p-ICU
Age
To 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
254
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethical Committee in Medical Research - Shahid Beheshti Medical University
Street address
Evin Ave, Shahid Beheshti Medical University
City
Tehran
Postal code
Approval date
2007-12-15, 1386/09/24
Ethics committee reference number
8448 / 3 / 10 / 25 / پ
Health conditions studied
1
Description of health condition studied
Intravenous catheter related infections
ICD-10 code
T82.7
ICD-10 code description
Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts
Primary outcomes
1
Description
Intravenous catheter related infection
Timepoint
During admission to discharge ftom the ward
Method of measurement
Superficial infections diagnosed with any sign of local infection including pain, local tenderness, warmness and fever without other causes that relieve after 24-48hrs of catheter removal. Blood stream infections diagnosed according to the National Nosocomial Infections Surveillance System (NNISS) with blood sampling after 48hrs of admission.
Secondary outcomes
1
Description
Duration of stay in the ward
Timepoint
At discharge
Method of measurement
Duration between admission to discharge (or death)
2
Description
Mortality due to any cause
Timepoint
At discharge
Method of measurement
By checking vital signs
Intervention groups
1
Description
Intervention group: Planecta infusion system including Planecta vial, Planecta spike, Planecta adaptore, Planecta port, Planecta triple port and Extension tube; In our study infusion systems will be introduced on admission untill discharge from the ward. Their setting-up and intervals for changing the devices will be done according to the manufacturers' advices.
Category
Treatment - Devices
2
Description
Control group: Routine Iranian infusion systems such as SUPA, including spike, adaptore, port, triple port and Extension tube; In our study infusion systems will be introduced on admission untill discharge from the ward. Their setting-up and intervals for changing the devices will be done according to the manufacturers' advices.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric infection research center Shahid Beheshti Medical University - Mofid Hosp. (Tehran)
Full name of responsible person
Dr Abdollah Karimi
Street address
Mofid Children Hosp., next to the Hoseinie-Ershad, Shariati Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Teda Co.
Full name of responsible person
Seyed Hossein Lesan
Street address
Teda building, No. 11.1, Niroo st, Shariati Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Teda Co.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Pediatric infection research center Shahid Beheshti Medical University
Full name of responsible person
Saeed Maham
Position
Physician
Other areas of specialty/work
Street address
Shariati Ave, Mofid Hosp.
City
Tehran
Postal code
Phone
+98 21 2222 6941
Fax
Email
mahamsm@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pediatric infection research center Shahid Beheshti Medical University
Full name of responsible person
Alireza Fahimzad
Position
Pediatric infectious dis. subspecialist
Other areas of specialty/work
Street address
Shariati Ave, Mofid Hosp.
City
Tehran
Postal code
Phone
+98 21 2222 6941
Fax
Email
safahimzad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Ahmad Reza Shamshiri
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
ar_shamshiri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)