The aim of this study is the comparison of catheter infection in temporary dialysis catheter with or without catheter lock by ethanol in renal failure patients. Inclusion criteria: Adult patient with renal failure needed dialysis with dialysis temporary catheter. Exclusion criteria: any Infection; inflammatory disease; neoplastic disease; patients treating with immunosuppressive agents.
Participants are 60 adult patients with renal failure needed dialysis with temporary catheter, who are divided in to 2 groups. In control group for performing hemodialysis, 1 cc heparin (5000 u) used in jugular vein according to standard rules. In intervention arm, 1 cc heparin (5000 u) locked catheter and 2 cc ethanol 60% will use for hemodialysis.
The number of dialysis is varied and depended on clinical situation. After one month catheter infection compare in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104272858N1
Registration date:2011-06-03, 1390/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-03, 1390/03/13
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
2009-09-23, 1388/07/01
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dialysis temporary catheter infection with or without ethanol lock
Public title
Effect of ethanol lock in prevention of dialysis catheter infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patient with renal failure needed to dialysis with dialysis temporary catheter
Exclusion criteria:
infection; inflammatory disease;neoplastic disease;immunosuppressive treating patients
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical faculty,Tabriz University of medical sciences
Street address
Daneshgah Ave.East Azerbaijan province
City
Tabriz
Postal code
5166614756
Approval date
2010-11-27, 1389/09/06
Ethics committee reference number
5/4/6874
Health conditions studied
1
Description of health condition studied
Catheter infection
ICD-10 code
T82.4
ICD-10 code description
Mechanical complication of vascular dialysis catheter
Primary outcomes
1
Description
Dialysis temporary catheter infection
Timepoint
In one month period after each dialysis if fever and chills develops and takes from blood and catheter fluid culture
Method of measurement
Blood culture,catheter aspirated fluid culture
Secondary outcomes
1
Description
Fever and chills
Timepoint
In one month period after each dialysis if fever and chills develops and takes from blood and catheter fluid culture
Method of measurement
Body temperature above 37.6 (with Thermometer)
Intervention groups
1
Description
Heparin (5000 U) 1cc And Ethanol (60%) 2cc;
Variable dialysis times in one month period;
Catheter locking after each time of dialysis
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dr.hamid tayebi khosroshahy
Street address
Emam Reza hospital,daneshgah ave.Tabriz,Province east Azerbaijan
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)