The most promising intervention for compensating kidney action in ESRD patients is hemodialysis. Using Central Venous Catheter (CVC) is common in hemodialysis patients. Having a catheter is a risk factor for inducing bacteremia among hemodialysis patients.
Management of Catheter-Related Bacteremia (CRB) is just by removing catheter with systemic antibiotic administration will result in atrial access problem. An antibiotic lock technique spreads for overcoming this problem. The aim of this study is using cotrimoxazole as an antibiotic lock solution for preventing from CRB in hemodialysis patient. This study is a kind of RCT which will perform in 90 ESRD patients who have recently a temporary central line catheter and have no active infection; Evidence of exit site of infection; Cirrhosis; encephalopathy; uncontrolled cancer; Any documented sensivity to sulfonamides family drugs as exclusion criateria. After getting permission, patients will stratified to two groups, antibiotic treated in catheter lumen as an antibiotic lock group or heparin administrated in catheter lumen as a control group. The end point of the study is CRB induction during 6 month follow up or until venous-arterial fistula maturation. CRB occurrence will compare between two groups at the end of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305313043N8
Registration date:2013-07-10, 1392/04/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-10, 1392/04/19
Registrant information
Name
Simin Dashti-Khavidaki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
dashtis@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluating of Cotrimoxazole as an antibiotic-lock solution in prophylaxis against Dialysis Catheter–Related Bacteremia
Public title
Cotrimoxazole as an antibiotic-lock solution in preventing Catheter–Related Bacteremia in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Recently diagnosed ESRD patients with temporary catheters.
Exclusion criteria: active infection; Evidence of exit site of infection; Cirrhosis; encephalopathy; uncontrolled cancer; Any documented sensivity to sulfonamides family drugs.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
16 azar Avn. tehran university of medical science
City
Tehran
Postal code
Approval date
2013-02-08, 1391/11/20
Ethics committee reference number
92-01-33-21582
Health conditions studied
1
Description of health condition studied
CKD patients in hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Catheter related infection occurence
Timepoint
during 6 month study, weekly assessment
Method of measurement
lab data from blood sample, clinical observation, follow up by questioniare
Secondary outcomes
1
Description
any cause of bacteremia infection
Timepoint
during 6 month study
Method of measurement
clinical observation
2
Description
Thrombosis in catheter
Timepoint
during 6 month study
Method of measurement
clinical observation
3
Description
any cause of hospitalization and length of hospitalization
Timepoint
during 6 month study
Method of measurement
clinical observation
4
Description
any cause of catheter removement
Timepoint
during 6 month study
Method of measurement
clinical observation
5
Description
any cause of mortality during study
Timepoint
during 6 month study
Method of measurement
clinical observation
6
Description
exit-site infection
Timepoint
during 6 month study
Method of measurement
clinical observation
7
Description
occurring of antibiotic resistance ( colony induction or resistance infection to antibiotic in lock solution)
Timepoint
during 6 month study
Method of measurement
lab data from blood sample
8
Description
fungal infection
Timepoint
during 6 month study
Method of measurement
lab data from blood sample
9
Description
adverse effects of antibiotic
Timepoint
during 6 month study
Method of measurement
clinical observation
10
Description
risk of unusual bleeding from catheter during dialysis
Timepoint
during 6 month study
Method of measurement
clinical observation
Intervention groups
1
Description
In experimental group: mix 2.5 ml ampule Cotrimoxazole ( 400/80) with 0.5 ml ampule heparin5000U then 1 ml distillated water added until total volume reach to 4 ml. In the end of dialysis section, each lumen of catheter were filled by this antibiotic solution. This action will repeat during maximum 6 month for each patient.
Category
Treatment - Drugs
2
Description
In Control group:1 ml of ampule heparin 5000 U with 3 ml distillated waterwill mix until total volume of 4 ml. In the end of dialysis section, each lumen of catheter were filled by this antibiotic solution. This action will repeat during maximum 6 month for each patient.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr.Efat Razeghi, nephrologist
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Emam Khomeni hospital
Full name of responsible person
Dr.Simin dashti, clinical pharmasict
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Simin dashti
Street address
cancer institute of tehran, Urology and Nephrology Research Center
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
faculty of pharmacy, Tehran university of medical science
Full name of responsible person
Dr. Simin dashti Khadivaki
Position
assistant professor, clinical pharmacist
Other areas of specialty/work
Street address
Tehran University of Medical Science, !6 Azar avenue, Enghelab Squre
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
dashtis@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Azadeh Moghaddas
Position
Pharm. D, resident of clinical pharmacy
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 31 1335 4956
Fax
Email
Azadeh_moghaddas@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)