Evaluation of the effect of Antibiotic Lock and Troulak in preventing catheter infection in hemodialysis patients
Design
This evaluation is a clinical trial in phase 3, hemodialysis patients with catheters are considered as a study group.In this study, 86 patients who meet the inclusion criteria are selected. Patients are randomly assigned and blocked by two categories.43 patients are in the Troulak group and 43 patients are in the Antibiotic lock group. Accordingly, after the end of each month, the rate of catheter infection in them is compared.
Settings and conduct
Site of Study: Imam Hossein Hospital, Tehran
Methods: This study is performed on two groups of hemodialysis patients in a three-blind manner. One group receives Troulak and the other group receives antibiotic lock. At the end of each month,blood culture will be prepared from the catheter of the patients.
Participants/Inclusion and exclusion criteria
Entry criteria for study: All the ESRD dialysis patients through permacath who Present informed consent for attending in the study.
Non-entry criteria:Patients who have past history of IV drug abusing ؛past history of active systemic infections before permacath insertion؛ changing the catheter to AV fistula؛past surgical history within the last year and past history of allergy to antibiotics are not allowed in study.
Intervention groups
Tauroloc or Tarolidin citrate group that causes reduction in the rate of infection compared to heparin use. Antibiotic lock group, which its effectiveness is under study.
Main outcome variables
Side effects from the treatment protocol Such as the possibility of drug resistance.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210921052544N1
Registration date:2022-05-01, 1401/02/11
Registration timing:registered_while_recruiting
Last update:2022-05-01, 1401/02/11
Update count:0
Registration date
2022-05-01, 1401/02/11
Registrant information
Name
Maryam Delgosha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7826
Email address
mary.delgosha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-20, 1401/01/31
Expected recruitment end date
2022-07-22, 1401/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Preventive Protocol for Central Venous Catheter-Related Infection (Antibiotic Lock Therapy and TauroLock) in Hemodialysis Patients.
Public title
Evaluation of Preventive Protocol for Central Venous Catheter-Related Infection (Antibiotic Lock Therapy and TauroLock) in Hemodialysis Patients.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All End Stage Renal Disease patients dialysis through permacath
Presenting informed consent for attending in study
Exclusion criteria:
Poor blood flow during dialysis
Past history of IV drug abusing
Past history of active systemic infections before permacath insertion
Change the catheter to AV fistula
Past surgical history whitin the last year
Past history of allergies to antibiotics
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The case-study patients are randomized into two groups. The allocation of patients in the two groups had been based on demographic characteristics and their assimilation. Accordingly, after the patients were divided into two equal groups in terms of number based on demographic information, we included the patients in the study and performed the desired intervention on them.
In this study, taurolock- manufactured by Tauropharm Gmbh Company- and the combination of vancomycin with heparin- manufactured by Exir Pharmaceutical Company- are visually numbered in similar ampoules and only the person in charge of the study knows the contents. The drugs are distributed in the dialysis center. Neither of nurse in charge and the patient know about the type of solution. Each patient is assigned an ID sheet contained the patient's details and the number of the solution of the received drug. Patients receive the solution randomly each time they are being on dialysis. The randomization method is simple and the randomization unit is the person who numbers the used ampoules in the random number table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this way, patients in the two groups, analyzer and outcome assessor, do not know about the drug used and the packaging of drugs is done in the same way
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Next to Ayatollah Taleghani Hospital -Shahid Arabi Street -Yemen Street - Shahid Chamran highway - Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2021-03-06, 1399/12/16
Ethics committee reference number
IR.SBMU.MSP.REC.1399.753
Health conditions studied
1
Description of health condition studied
Catheter infection
ICD-10 code
T80.211A
ICD-10 code description
Bloodstream infection due to central venous catheter, initial encounter
2
Description of health condition studied
Hemodyalisis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
The rate of catheter infection in hemodialysis patients
Timepoint
Checking blood culture from catheter lines and peripheral blood at the end of each month
Method of measurement
Culture of catheter lines and peripheral blood
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group one( Taurolock manufactured by TauroPharm GmbH Company): At the end of each dialysis, the patient's premcath lines are filled with taurolock and each month blood culture sample is prepare from the patient's premcath lines.Also blood culture sample is prepared from peripheral blood and permacath in the case of symptoms of infection.
Category
Prevention
2
Description
Intervention group two(Antibiotic lock-combination of vancomycin and heparin manufactured by Exir Pharmaceutical Company):At the end of each dialysis, the patient's premcath lines are filled with antibiotic lock and each month blood culture sample is prepare from the patient's premcath lines.Also blood culture sample is prepared from peripheral blood and permacath in the case of symptoms of infection.