This study will be conducted with aim to survey the effectiveness of Taurolock on central venous catheter infection in dialysis patients. This study is a single blind clinical trial in 1-2 phase. The study population will be consisted of hemodialysis patients referred to Imam Khomeini and Imam Reza hospital in Kermanshah city that 60 persons will selected in available method and randomly will be assigned to two experimental and control groups. In the experimental group Taurolock in half the usual dose with heparin in catheters Locke Lines is given at the end of each dialysis session. Dialysis patients in the control group will not receive Taurolock. Baseline, Once every three months, and end of the study, the incidence of infection is checked.
With signs of infection attributed bacteremia, two blood cultures taken from the Permi - Ket and in case of positive blood cultures,the effect of Taurolock on central venous catheter infection in dialysis patients is confirmed.
Inclusion criteria: patients undergoing chronic hemodialysis through Permi – Ket; written consent of the patient.
Exclusion criteria: IV Drug Abuse; Change the dialysis of Permi – Ket to the AVF; Having a history of surgery
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020221066N2
Registration date:2016-04-18, 1395/01/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-18, 1395/01/30
Registrant information
Name
Sima Golmohammadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3839 7545
Email address
s.golmohammadi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-04-13, 1395/01/25
Expected recruitment end date
2017-04-14, 1396/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness and non effectiveness of Taurolock on central venous catheter infection in dialysis patients
Public title
Survey the effect of Taurolock on central venous catheter infection in dialysis patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing chronic hemodialysis through Permi – Ket; written consent of the patient.
Exclusion criteria: IV Drug Abuse; Change the dialysis of Permi – Ket to the AVF; Having a history of surgery
Age
From 15 years old to 80 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-11-24, 1394/09/03
Ethics committee reference number
kums.rec.1394.200
Health conditions studied
1
Description of health condition studied
End stage kidney disease
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease
Primary outcomes
1
Description
Infection
Timepoint
Baseline, Once every three months, end of the study
Method of measurement
In the laboratory by blood cultures
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group Taurolock( made in germany) in half the usual dose with heparin in catheters Locke Lines is given at the end of each dialysis session.
Category
Treatment - Drugs
2
Description
In the control group dialysis patients will not receive Taurolock.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Elaheh Sharifi
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
2
Recruitment center
Name of recruitment center
Emam Khomeyni Hospital
Full name of responsible person
Dr. Elaheh Sharifi
Street address
Emam Khomeyni Hospital, Naghliyeh Street
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, Street of Hezarjarib
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Elaheh Sharifi
Position
Internal Assistant
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
Eesharifi1348@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sima Golmohammadi
Position
Subspecialty of nephrology
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
s.golmohammadi@KUMS.AC.IR
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Elaheh Sharifi
Position
Internal Assistant
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
Eesharifi1348@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)