Clinical trial NCT02618317: Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis
Official title: Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: renal dialysis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-12-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Poor Blood Flow Rate(BFR)
timeFrame: 100 days
Secondary outcomes:
measure: Adverse Drug Reactions Related to lock solutions (ADR)
timeFrame: 100 days
measure: Cather-Related Blood Stream Infection (CRBSI)
timeFrame: 100 days
Other outcomes:
Locations:
city: Guarulhos
country: Brazil
facility: Integrated Centre of Nephrology
state: Sao Paulo
Study officials:
affiliation: PhD student
name: Marcus Luiz, MSc, PharmD
role: PRINCIPAL_INVESTIGATOR
References: