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

NCT02618317 | Completed Phase 4 DMC

• 1 other identifier: USaoPaulo CLOCK
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

renal dialysis

Outcome Measures

Primary Outcomes (1)

• 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

  100 days

Secondary Outcomes (2)

• Adverse Drug Reactions Related to lock solutions (ADR)

  100 days

• Cather-Related Blood Stream Infection (CRBSI)

  100 days

Study Arms (3)

Heparin Lock Solution

ACTIVE COMPARATOR

Patients on Heparin 1,000 U/ml locking solution, administered at the end of each dialysis session during a 15-week period .

Drug: Heparin Lock Solution

Trissodium Citrate 30%

EXPERIMENTAL

Patients on trissodium citrate 30% locking solution, administered at the end of each dialysis session during a 15-week period .

Drug: Trissodium Citrate 30%

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

EXPERIMENTAL

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.

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

Interventions

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.

Also known as: Hemofol (Traade Mark)

Heparin Lock Solution

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.

Also known as: CitraLock(Trade Mark)

Trissodium Citrate 30%

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.

Also known as: Cath-Safe (Trade Mark)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Integrated Centre of Nephrology

Guarulhos, São Paulo, 07013-142, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Marcus Luiz, MSc, PharmD

  PhD student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc., Pharm.D.

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: December 1, 2015
• Study Start: July 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 2, 2016

Record last verified: 2016-11

Locations

BR (1)