The aim of this study is comparison between the effect of systemic antibiotic with and without ethanol lock solution in treatment of hemodialysis catheter related infection in patients with renal failure. Inclusion criteria: Adult patient with renal failure who develop fever and chills During dialysis Exclusion criteria: other sources of infection outside the dialysis catheter ; death because of any reason other than catheter infection ; catheter removal due to maturation of arteriovenous fistulas or grafts . participints are 64 adult patients with renal failure needed hemodialysis with catheter who are divided into 2 groups; in both of them empirical antibiotic with vancomycin and 3th generation cephalosporin or aminoglycoside begins and will modify after obtaining the blood culture results . in control group for performing hemodialysis 1cc heparin(5000u)uses in lumen of catheter according to standard rules ; in intervention arm 1cc heparin(5000u) locked catheter and 2cc ethanol 60%will use for hemodialysis ; after 3 weeks of treatment catheter infection will compare in two groups .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106062858N4
Registration date:2011-08-15, 1390/05/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-15, 1390/05/24
Registrant information
Name
Hamid Taieby Khosroshahy
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3966
Email address
khosroshahyh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University Of Medical Sciences
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2011-06-21, 1390/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison between effect of systemic antibiotic with and without ethanol lock solution in treatment of hemodialysis catheter related infection
Public title
Effect of ethanol lock in treatment of hemodialysis catheter infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Adult patient with renal failure who develop fever and chills During dialysis Exclusion criteria: other sources of infection outside the dialysis catheter ; death because of any reason other than catheter infection ; catheter removal due to maturation of arteriovenous fistulas or grafts
Age
From 15 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical faculty,Tabriz University of medical sciences
Street address
Emam Reza hospital,Daneshgah ave.
City
Tabriz
Postal code
5166614756
Approval date
2010-07-08, 1389/04/17
Ethics committee reference number
5/4/2712
2
Ethics committee
Name of ethics committee
Medical faculty,Tabriz University of medical sciences
Street address
Emam Reza hospital,Daneshgah ave.
City
Tabriz
Postal code
5166614756
Approval date
2010-07-08, 1389/04/17
Ethics committee reference number
5/4/2712
Health conditions studied
1
Description of health condition studied
infection of hemodialysis catheter
ICD-10 code
T82.4
ICD-10 code description
Mechanical complication of vascular dialysis catheter
Primary outcomes
1
Description
infection of hemodialysis catheter
Timepoint
before the intervention In case of fever and chills during the dialysis blood cultures and cultures of the catheter is taken
Method of measurement
blood culture;Culture of fluid aspirated from the catheter lumen
Secondary outcomes
1
Description
fever and chills
Timepoint
Before the intervention and during each dialysis
Method of measurement
Using a thermometer and a temperature above 38
Intervention groups
1
Description
One cc of heparin 5000 units and 2cc of ethanol 60% three weeks of dialysis;Lock the catheter after each dialysis Plus systemic antibiotics for three weeks in the intervention group
Category
Treatment - Drugs
2
Description
One cc of heparin 5000 units three weeks of dialysis;Lock the catheter after each dialysis Plus systemic antibiotics for three weeks in the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dr.Hamid tayeby khosroshahy
Street address
Emam Reza hospital,daneshgah ave.Tabriz,Province east Azerbaijan -Iran, Islamic Republic Of
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr.hamid tayebi khosroshahy
Street address
Emam Reza hospital,Daneshgah ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz university of medical sciences
Full name of responsible person
Dr.hamid tayebi khosroshahy
Position
Internal medicine specialist/nephrology sub specialist/Chief of nephrology ward of Emam reza hospita
Other areas of specialty/work
Street address
Daneshgah ave.-Emam Reza hospital
City
Tabriz
Postal code
5166614756
Phone
+98 41 1334 4339
Fax
+98 41 1335 7850
Email
khosroshahyh@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr.Hamid tayeby khosroshahy
Position
Internal medicine specialist-nephrology sub specialist
Other areas of specialty/work
Street address
Emam Reza hospital,Daneshgah Ave.
City
Tabriz
Postal code
5166614756
Phone
+98 41 1334 4339
Fax
+98 41 1335 7850
Email
khosroshahyh@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr.Hamid Tayeby Khosroshahy
Position
Internal medicine specialist-nephrology sub specialist/Chief of nephrology ward
Other areas of specialty/work
Street address
Emam reza hospital,Daneshgah Ave.
City
Tabriz
Postal code
5166614756
Phone
+98 41 1334 4339
Fax
+98 41 1335 7850
Email
khosroshahyh@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)