Comparison of the effectiveness of cefazolin-heparin lock therapy and ethanol-heparin lock therapy on the persistence and site infection in hemodialysis catheter patients
Comparison of the effectiveness of cefazolin-heparin lock and ethanol-heparin lock on the persistence and site infection catheters in hemodialysis patients
Design
This clinical trial with two intervention groups, double-blind, randomized, was performed on 80 patients.
Settings and conduct
This study is in the field of prevention of infection and increasing the shelf life of hemodialysis catheter.
The study population consists of all hemodialysis patients with hemodialysis catheters.
Blinding in this study includes a statistical evaluator and a nurse blocking solutions.
Solutions in both study groups are blocked at the end of each hemodialysis session in patients' catheters.
Until the next hemodialysis session, these solutions remain in the catheters. In the next hemodialysis, the patient is first evaluated for signs of infection.
The blocked solution is then aspirated from the catheters and hemodialysis is started.
Participants/Inclusion and exclusion criteria
Informed consent
Referral and introduction of the patient by the physician
Age over 18 years
Intervention groups
ethanol-heparin lock group
cefazoline-heparin lock group
Main outcome variables
-It is a cost-effective method compared to similar methods.
-Reduce infection and increase catheter longevity.
-Prevent wasting effective hemodialysis time and thus increase life expectancy in patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210811052145N1
Registration date:2021-09-29, 1400/07/07
Registration timing:retrospective
Last update:2021-09-29, 1400/07/07
Update count:0
Registration date
2021-09-29, 1400/07/07
Registrant information
Name
Seyed mehdi Hosseinifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3242 9362
Email address
mehdi.hoseinifard@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-08-13, 1400/05/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of cefazolin-heparin lock therapy and ethanol-heparin lock therapy on the persistence and site infection in hemodialysis catheter patients
Public title
Comparison of the effectiveness of cefazolin-heparin lock therapy and ethanol-heparin lock therapy on the persistence and site infection in hemodialysis catheter patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Referral and introduction of the patient by the physician
over 18 years old
Exclusion criteria:
Lack of willingness to participate
use of systemic antibiotics
Use of immunosuppressive drugs
Having a previous catheter or systemic infection
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple and individual random method was used. In this way, based on the sample size of the study and using the table of random number allocation, 80 codes from number one to eighty were assigned to patients (Randomized Allocation). Then the patients were randomly assigned to two intervention groups. ELT (Ethanol lock therapy) expression was considered for ethanol block group and ALT(Antibiotic lock therapy) expression was considered for cefazolin block group. Finally, after the researcher referred to the hemodialysis center, the eligible patients were assigned to two intervention groups based on the order of randomized codes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, nurses and statistical analysts are unaware of the type of block and groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of hormozgan University of Medical Sciences
Street address
Islamic Republic of Iran Blvd, shahid mohammadi hospital
City
Bandar abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2019-05-29, 1398/03/08
Ethics committee reference number
052.۱۳۹۸.REC.HUMS.IR
Health conditions studied
1
Description of health condition studied
catheters site infection in hemodialysis pationts
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Prevention of catheter site infection
Timepoint
daily
Method of measurement
Redness - Sensitivity to touch - Hardening of catheter tissue about 2 cm - No fever or fever.
Secondary outcomes
1
Description
Increased catheter durability
Timepoint
daily
Method of measurement
From the time the catheter is inserted until the onset of symptoms of infection
Intervention groups
1
Description
ethanol-heparin block group: In the ethanol-heparin block group, participants received routine and standardized care after the end of the hemodialysis process, which included rinsing the catheter lumens with normal saline. Finally, the ethanol-heparin block solution with a ratio of 2 (ethanol) to 1 (heparin) was blocked by a research colleague according to the volume of catheter lumens. It should be noted that the volume of the catheter lumens is about 3CC. The solution remains in the catheter until the next visit. At the next visit before hemodialysis, first evaluate the patient, including weight control and blood pressure by the researcher and complete the checklist for catheter infection according to the CDC criteria, which includes redness, tenderness, hardening of the catheter tissue about 2 cm, presence Or the absence of fever was done by the researcher and the ward manager. The blocked solution is then aspirated and hemodialysis is started.
Category
Prevention
2
Description
cefazolin lock group: In the cephazolin-heparin block group, after the end of the hemodialysis process, they received routine and standard care, which included rinsing the catheter lumens with normal saline, then cefazolin-heparin block solution with a ratio of 2 (cefazolin) to 1 (heparin). Was ready, Due to the lumen volume, the catheter was blocked by a research colleague. It should be noted that the volume of the catheter lumens is about 3CC. The solution remains in the catheter until the next visit. At the next visit before hemodialysis, the patient first evaluates the patient, including weight control and blood pressure, and completes a checklist for catheter infection according to the CDC criteria, which includes redness, tenderness, and hard The tissue of the catheter site is about 2 cm, the presence or absence of fever, was done by the researcher and the ward manager. Then the blocked solution is aspirated and hemodialysis is started. The solution remains in the catheter until the next visit. At the next visit before hemodialysis, first evaluate the patient, including weight control and blood pressure by the researcher and complete the checklist for catheter infection according to the CDC criteria, which includes redness, tenderness, hardening of the catheter tissue about 2 cm, presence Or the absence of fever was done by the researcher and the ward manager. The blocked solution is then aspirated and hemodialysis is started.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
dialysis Center of in Bandar Abbas
Full name of responsible person
Dr hadi yousefi
Street address
Islamic Republic of Iran Boulevard
City
Bandar abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 38 3242 9362
Email
mehdi.hosseinifard@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Hadi Yousefi
Street address
Islamic Republic of Iran Boulevard
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 38 3242 9362
Email
mehdi.hosseinifard@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
researcher
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Seyed Mehdi Hosseinifard
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.14, 28Ave., Fadaeian Blvd., Farrokhshahr Town
City
Farrokhshahr
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8831855659
Phone
+98 38 3242 9362
Fax
Email
mehdi.hosseinifard@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr.Hadi Yousefi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Imam Hussain Boulevard
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 4429
Email
hadiyousefi17@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
mehdi hosseinifard
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.14,28 Ave,fadieyan eslam Blvd,farrokh shahr Town
City
farrokh shahr
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8831855659
Phone
+98 38 3242 9362
Email
mehdi.hosseinifard@yahoo.com
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
No - There is not 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