Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis (CLOCK)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Heparin Lock Solution
Trissodium Citrate 30%
Minocycline-EDTA 30 mg/ml - 3 mg/ml
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease focused on measuring renal dialysis
Eligibility Criteria
Inclusion Criteria:
- male and female patients;
- patients with subclavian long term central venous catheter;
- patients on on high-efficiency hemodialysis (BFR= 350 ml; dialisate flow = 500 ml; 3 times; 4-hour sessions).
Exclusion Criteria:
- pregnant; patients on oral coagulants; patients aged less than 18 years;
- patients aged more than 75 years
Sites / Locations
- Integrated Centre of Nephrology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Heparin Lock Solution
Trissodium Citrate 30%
Minocycline-EDTA 30 mg/ml - 3 mg/ml
Arm Description
Patients on Heparin 1,000 U/ml locking solution, administered at the end of each dialysis session during a 15-week period .
Patients on trissodium citrate 30% locking solution, administered at the end of each dialysis session during a 15-week period .
Patients on Minocycline 30 mg/ml/EDTA 3 mg/ml locking solution, administered at the end of each dialysis session during a 15-week period.
Outcomes
Primary Outcome Measures
Poor Blood Flow Rate(BFR)
Reduction of 35 ml in the BFR of 2350 ml on hemodialysis is considered a primary endpoint for this trial
Secondary Outcome Measures
Adverse Drug Reactions Related to lock solutions (ADR)
ADR is considered secondary endpoint for this trial
Cather-Related Blood Stream Infection (CRBSI)
CRBSI is considered secondary endpoint for this trials
Full Information
NCT ID
NCT02618317
First Posted
September 18, 2015
Last Updated
November 30, 2016
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02618317
Brief Title
Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis
Acronym
CLOCK
Official Title
Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: Poor flow (PF) and catheter-related blood stream infections (CRBSI) are highly prevalent among CKD 5D patients with long-term central venous catheters. Heparin (H) catheter lock solutions are commonly used to maintain catheter patency, however PF and CRBSI incidence remains high. The purpose of this study was to evaluate two lock solutions on reduction of PF and CRBSI: one, a lock solution combining of the tetracycline antibiotic minocycline with the anticoagulant/chelation agent EDTA (M-EDTA) versus H; and other, trisodium citrate (C) versus H. M-EDTA and C were also evaluated as to their safety versus H.
Methods:As regards the pilot project, thirty CKD 5D patients on high-efficiency hemodialysis (blood flow rate = 350 ml/min) at the Integrated Centre of Nephrology (Guarulhos, Brazil) were randomized 1:1:1 to receive M-EDTA, C or H locks for 15 weeks. Lock solutions concentrations were M-EDTA 30 mg/ml/3 mg/ml, C 30% (C) and H 1,000 U/ml and both investigators and patients were blinded to treatment allocation. The primary end-point was a 10% reduction in HD blood flow rates (35ml). The frequency of CRBSI was recorded. Bleeding and lock solution-related adverse events were the primary safety end points. Logistic Regression was performed to evaluate differences in PF rates among the treatments (SPSS version 13.0, IBM, USA).
Based upon the pilot-study data, the clinical trials has being executed in order to verify whether the three lock solutions have the same performance or not.
Detailed Description
Methods: 75 CKD 5D patients on high-efficiency hemodialysis (blood flow rate = 350 ml/min) at the Integrated Centre of Nephrology (Guarulhos, Brazil) will be randomized 1:1:1 to receive M-EDTA, C or H locks for 15 weeks. Lock solutions concentrations are M-EDTA 30 mg/ml/3 mg/ml, C 30% (C) and H 1,000 U/ml and both investigators and patients are blinded to treatment allocation. The primary end-point is a 10% reduction in HD blood flow rates (35ml). The frequency of CRBSI will be recorded. Poor Flow Rate (event/1,000 catheter-day) and CRBSI Rate (event/1,000 catheter-day) will be calculated in each arm. Bleeding and lock solution-related adverse events are also the primary safety end points and their rates (events/1,000 catheter-day) will be calculated. Logistic Regression will be performed to evaluate differences in PF, CRBSI, Bleeding and lock solution-related adverse events rates among the treatments (SPSS version 13.0, IBM, USA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
renal dialysis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heparin Lock Solution
Arm Type
Active Comparator
Arm Description
Patients on Heparin 1,000 U/ml locking solution, administered at the end of each dialysis session during a 15-week period .
Arm Title
Trissodium Citrate 30%
Arm Type
Experimental
Arm Description
Patients on trissodium citrate 30% locking solution, administered at the end of each dialysis session during a 15-week period .
Arm Title
Minocycline-EDTA 30 mg/ml - 3 mg/ml
Arm Type
Experimental
Arm Description
Patients on Minocycline 30 mg/ml/EDTA 3 mg/ml locking solution, administered at the end of each dialysis session during a 15-week period.
Intervention Type
Drug
Intervention Name(s)
Heparin Lock Solution
Other Intervention Name(s)
Hemofol (Traade Mark)
Intervention Description
Just after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution.
Intervention Type
Drug
Intervention Name(s)
Trissodium Citrate 30%
Other Intervention Name(s)
CitraLock(Trade Mark)
Intervention Description
ust after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution.
Intervention Type
Drug
Intervention Name(s)
Minocycline-EDTA 30 mg/ml - 3 mg/ml
Other Intervention Name(s)
Cath-Safe (Trade Mark)
Intervention Description
ust after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution.
Primary Outcome Measure Information:
Title
Poor Blood Flow Rate(BFR)
Description
Reduction of 35 ml in the BFR of 2350 ml on hemodialysis is considered a primary endpoint for this trial
Time Frame
100 days
Secondary Outcome Measure Information:
Title
Adverse Drug Reactions Related to lock solutions (ADR)
Description
ADR is considered secondary endpoint for this trial
Time Frame
100 days
Title
Cather-Related Blood Stream Infection (CRBSI)
Description
CRBSI is considered secondary endpoint for this trials
Time Frame
100 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male and female patients;
patients with subclavian long term central venous catheter;
patients on on high-efficiency hemodialysis (BFR= 350 ml; dialisate flow = 500 ml; 3 times; 4-hour sessions).
Exclusion Criteria:
pregnant; patients on oral coagulants; patients aged less than 18 years;
patients aged more than 75 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Luiz, MSc, PharmD
Organizational Affiliation
PhD student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrated Centre of Nephrology
City
Guarulhos
State/Province
Sao Paulo
ZIP/Postal Code
07013-142
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis
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