Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis

Phase 4

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Heparin Lock Solution; Drug: Minocycline-EDTA 30 mg/ml - 3 mg/ml; Drug: Trissodium Citrate 30%

• Registration Number: NCT02618317
• Lead Sponsor: University of Sao Paulo

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).

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-12-01
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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).

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Exclusion Criteria

• pregnant; patients on oral coagulants; patients aged less than 18 years;
• patients aged more than 75 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin Lock Solution	Heparin Lock Solution	Patients on Heparin 1,000 U/ml locking solution, administered at the end of each dialysis session during a 15-week period .
Minocycline-EDTA 30 mg/ml - 3 mg/ml	Minocycline-EDTA 30 mg/ml - 3 mg/ml	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.
Trissodium Citrate 30%	Trissodium Citrate 30%	Patients on trissodium citrate 30% locking solution, administered at the end of each dialysis session during a 15-week period .

Primary Outcome Measures

Name	Time	Method
Poor Blood Flow Rate(BFR)	100 days	Reduction of 35 ml in the BFR of 2350 ml on hemodialysis is considered a primary endpoint for this trial

Secondary Outcome Measures

Name	Time	Method
Cather-Related Blood Stream Infection (CRBSI)	100 days	CRBSI is considered secondary endpoint for this trials
Adverse Drug Reactions Related to lock solutions (ADR)	100 days	ADR is considered secondary endpoint for this trial

Trial Locations

Locations (1)

Integrated Centre of Nephrology; 🇧🇷 Guarulhos, Sao Paulo, Brazil