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Completed

NCT Number: NCT02618317

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Integrated Centre of Nephrology

Guarulhos, São Paulo, 07013-142, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heparin Lock Solution

Drug

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.

Other names: Hemofol (Traade Mark)

Trissodium Citrate 30%

Drug

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.

Other names: CitraLock(Trade Mark)

Minocycline-EDTA 30 mg/ml - 3 mg/ml

Drug

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.

Other names: Cath-Safe (Trade Mark)

Primary outcomes

  1. Poor Blood Flow Rate(BFR)

    Time frame: 100 days

    Reduction of 35 ml in the BFR of 2350 ml on hemodialysis is considered a primary endpoint for this trial

Secondary outcomes

  1. Adverse Drug Reactions Related to lock solutions (ADR)

    Time frame: 100 days

    ADR is considered secondary endpoint for this trial

  2. Cather-Related Blood Stream Infection (CRBSI)

    Time frame: 100 days

    CRBSI is considered secondary endpoint for this trials

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Acronym: CLOCK

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 1, 2015
Registry last updated
Dec 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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