The effect of Ceftazidime and Cloxacillin as an antibiotic lock solution for prevention of hemodialysis tunneled-catheter related blood stream infection in patients with chronic kidney disease
The aim of this clinical trial study was to evaluate the effect of Ceftazidime and Cloxacillin as an antibiotic lock solution for prevention of hemodialysis tunneled-catheter related blood stream infection. From patients with chronic kidney disease requiring dialysis with tunneled hemodialysis catheter referring to hemodialysis center of Tohid hospital, Sanandaj, Iran total of 40 patients were selected and randomly divided into intervention and control groups. Inclusion criteria included: patients with chronic kidney disease requiring dialysis with tunneled hemodialysis catheter. Exclusion criteria included: changing vascular access to AVF, kidney transplant during the study, transferring patients to other centers, patients’ unwillingness to participate in the study, using Taurolock as lock solution, patients who were candidate for antibiotic prescription for reasons other than CRBSI. In the intervention group based on the volume recorded on the catheter 10 mg / ml ceftazidime plus 100 mg / ml cloxacillin and 5000 units of heparin injected into the lumen of the catheter after each hemodialysis session and catheter locked. In the control group only 5000 units of heparin injected into the lumen of the catheter after each hemodialysis session and catheter locked. All patients were examined during the dialysis for catheter infection, adverse drug reactions, skin reactions and other side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060212789N15
Registration date:2017-07-18, 1396/04/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-18, 1396/04/27
Registrant information
Name
Masoud Rasolabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4654
Email address
rasolabady@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Kurdistan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ceftazidime and Cloxacillin as an antibiotic lock solution for prevention of hemodialysis tunneled-catheter related blood stream infection in patients with chronic kidney disease
Public title
Effect of Ceftazidime and Cloxacillin for prevention of hemodialysis tunneled -catheter related blood stream infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with chronic kidney disease requiring dialysis with tunneled hemodialysis catheter. Exclusion criteria: changing vascular access to AVF; kidney transplant during the study; transferring patients to other centers; patients’ unwillingness to participate in the study; using Taurolock as lock solution; patients who were candidate for antibiotic prescription for reasons other than CRBSI.
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics committee of Kurdistan university of Medical Sciences
Street address
Kurdistan university of Medical Sciences,Pasdaran St., Sanandaj , Iran
City
Sanandaj
Postal code
Approval date
2016-05-14, 1395/02/25
Ethics committee reference number
IR.MUK.REC.1395.60
Health conditions studied
1
Description of health condition studied
Bacterial infection, unspecified
ICD-10 code
A49.9
ICD-10 code description
Bacteraemia NOS
Primary outcomes
1
Description
Catheter-related bloodstream infection (CRBSI)
Timepoint
After each session hemodialysis for six months
Method of measurement
Clinical examination of infection and blood culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: based on the volume recorded on the catheter 10 mg / ml ceftazidime plus 100 mg / ml cloxacillin and 5000 units of heparin injected into the lumen of the catheter after each hemodialysis session and catheter locked
Category
Treatment - Drugs
2
Description
Control group: 5000 units of heparin injected into the lumen of the catheter after each hemodialysis session and catheter locked.