Effect of using Cloxacillin as an "Antibiotic Lock Solution" versus placebo on prevention of catheter-associated infection in hemodialysis patients: a single-blind randomized clinical trial
To assess the effect of using Cloxacillin as an "Antibiotic Lock Solution" versus placebo on prevention of catheter-associated infection in hemodialysis patients
Design
This is a single-blind randomized clinical trial, phase II, in which 124 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible hemodialysis patients who will refer to Shahid Beheshti Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be single-blinded so that neither patients nor the physician who will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 80 years
Hemodialysis
Exclusion criteria:
Using immunosuppressive drugs
Intervention groups
Intervention group:
Injection of 100 mg/dl Cloxacillin and 1000 IU/ml heparin intra-catheter in every dialysis for 4 weeks
Control group:
Injection of 100 mg normal saline and 1000 IU/ml heparin intra-catheter in every dialysis for 4 weeks
Main outcome variables
Primary outcome:
Assessing the catheter-associated infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N272
Registration date:2019-04-30, 1398/02/10
Registration timing:prospective
Last update:2019-04-30, 1398/02/10
Update count:0
Registration date
2019-04-30, 1398/02/10
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of using Cloxacillin as an "Antibiotic Lock Solution" versus placebo on prevention of catheter-associated infection in hemodialysis patients: a single-blind randomized clinical trial
Public title
Effect of using Cloxacillin as an "Antibiotic Lock Solution" versus placebo on prevention of catheter-associated infection in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 80 years
Hemodialysis
Exclusion criteria:
Using immunosuppressive drugs
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. Thus, the trial will be run as single-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-10-13, 1397/07/21
Ethics committee reference number
IR.UMSHA.REC.1397.484
Health conditions studied
1
Description of health condition studied
Catheter-associated infection
ICD-10 code
T80.21
ICD-10 code description
Infection due to central venous catheter
Primary outcomes
1
Description
Assessing the catheter-associated infection
Timepoint
Every week for 4 weeks
Method of measurement
Through physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of 100 mg/dl Cloxacillin and 1000 IU/ml heparin intra-catheter in every dialysis for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: Injection of 100 mg normal saline and 1000 IU/ml heparin intra-catheter in every dialysis for 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Hamadan City
Full name of responsible person
Ranyar Abdi
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
ranyarabdi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ranyar Abdi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
ranyarabdi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mahmoof Gholiaf
Position
Nephrologist
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
gholyaf@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available