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Comparison of heparin to citrate as a catheter locking solution for non-tunneled central venous hemodialysis catheters in patients requiring renal replacement therapy for acute renal failure (VERROU-REA study): study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:The incidence of acute kidney injury (AKI) is estimated at 10 to 20% in patients admitted to intensive care units (ICU) and often requires renal replacement therapy (RRT). ICU mortality in AKI patients can exceed 50%. Venous catheters are the preferred vascular access method for AKI patients requiring RRT, but carry a risk of catheter thrombosis or infection. Catheter lock solutions are commonly used to prevent such complications. Heparin and citrate locks are both widely used for tunneled, long-term catheters, but few studies have compared citrate versus heparin for patients with short-term, non-tunneled catheters. We aim to compare citrate 4% catheter lock solution versus heparin in terms of event-free survival of the first non-tunneled hemodialysis catheter inserted in ICU patients with AKI requiring RRT. Secondary objectives are the rate of fibrinolysis, incidence of catheter thrombosis and catheter-related infection per 1,000 catheter days, length of stay in ICU and in-hospital and 28-day mortality. METHODS/DESIGN:The VERROU-REA study is a randomized, prospective, multicenter, double-blind, parallel-group, controlled superiority study carried out in the medical, surgical and nephrological ICUs of two large university hospitals in eastern France. A catheter lock solution composed of trisodium citrate at 4% will be compared to unfractionated heparin at a concentration of 5,000 IU/mL. All consecutive adult patients with AKI requiring extracorporeal RRT, and in whom a first non-tunneled catheter is to be inserted by the jugular or femoral approach, will be eligible. Catheters inserted by the subclavian approach, patients with acute liver failure, thrombopenia or contraindication to systemic anticoagulation will be excluded. Patients will be followed up daily in accordance with standard practices for RRT until death or discharge. DISCUSSION:Data is scarce regarding the use of non-tunneled catheters in the ICU setting in patients with AKI. This study will provide an evidence base for recommendations regarding the use of anticoagulant catheter locks for the prevention of dysfunction in non-tunneled hemodialysis catheters in patients with AKI in critical or intensive care. TRIAL REGISTRATION:Registered with Clinicaltrials.gov (registration number: NCT01962116) on 27 August 2013.

SUBMITTER: Bruyere R

PROVIDER: S-EPMC4289224 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Comparison of heparin to citrate as a catheter locking solution for non-tunneled central venous hemodialysis catheters in patients requiring renal replacement therapy for acute renal failure (VERROU-REA study): study protocol for a randomized controlled trial.

Bruyère Rémi R Soudry-Faure Agnès A Capellier Gilles G Binquet Christine C Nadji Abdelouaid A Torner Stephane S Blasco Gilles G Yannaraki Maria M Barbar Saber Davide SD Quenot Jean-Pierre JP

Trials 20141119

<h4>Background</h4>The incidence of acute kidney injury (AKI) is estimated at 10 to 20% in patients admitted to intensive care units (ICU) and often requires renal replacement therapy (RRT). ICU mortality in AKI patients can exceed 50%. Venous catheters are the preferred vascular access method for AKI patients requiring RRT, but carry a risk of catheter thrombosis or infection. Catheter lock solutions are commonly used to prevent such complications. Heparin and citrate locks are both widely used ...[more]

PMID: 25409678

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Project description:BACKGROUND:Non-tunneled hemodialysis catheters are currently used for critically ill patients with acute kidney injury requiring extracorporeal renal replacement therapy. Strategies to prevent catheter dysfunction and infection with catheter locks remain controversial. METHODS:In a multicenter, randomized, controlled, double-blind trial, we compared two strategies for catheter locking of non-tunneled hemodialysis catheters, namely trisodium citrate at 4% (intervention group) versus unfractionated heparin (control group), in patients aged 18 years or older admitted to the intensive care unit and in whom a first non-tunneled hemodialysis catheter was to be inserted by the jugular or femoral vein. The primary endpoint was length of event-free survival of the first non-tunneled hemodialysis catheter. Secondary endpoints were: rate of fibrinolysis, incidence of catheter dysfunction and incidence of catheter-related bloodstream infection (CRBSI), all per 1000 catheter-days; number of hemorrhagic events requiring transfusion, length of stay in intensive care and in hospital; 28-day mortality. RESULTS:Overall, 396 randomized patients completed the trial: 199 in the citrate group and 197 in the heparin group. There was no significant difference in baseline characteristics between groups. The duration of event-free survival of the first non-tunneled hemodialysis catheter was not significantly different between groups: 7 days (IQR 3-10) in the citrate group and 5 days (IQR 3-11) in the heparin group (p = 0.51). Rates of catheter thrombosis, CRBSI, and adverse events were not statistically different between groups. CONCLUSIONS:In critically ill patients, there was no significant difference in the duration of event-free survival of the first non-tunneled hemodialysis catheter between trisodium citrate 4% and heparin as a locking solution. Catheter thrombosis, catheter-related infection, and adverse events were not statistically different between the two groups. Trial registration Registered with Clinicaltrials.gov under the number NCT01962116. Registered 14 October 2013.

Project description:BackgroundSodium bicarbonate (NaHCO3) is one of the promising solutions that has good safety profile and theoretical advantages regarding antimicrobial and antithrombotic properties but there are still limited reports.ObjectiveTo compare the efficacy in lowering rate of catheter loss due to catheter-related thrombosis (CRT) or catheter-related blood stream infection (CRBSI) between sodium bicarbonate and heparin lock in prevalent chronic hemodialysis (HD) patients.DesignA multicenter, randomized, open-label study.SettingIn a developing country, Thailand.PatientsChronic HD patients with tunneled central venous catheter.MeasurementsCatheter loss rate, rate of catheter-related blood stream infection, catheter-related thrombosis, and exit site or tunnel infection.MethodsThe prospective multicenter randomized controlled trial was conducted, we randomly assigned 118 patients undergoing HD with tunneled central venous catheter to receive a catheter locking solution of sodium bicarbonate or heparin. The primary outcome was a catheter loss rate due to CRT or CRBSI, while the secondary outcome was a composite outcome of CRT, CRBSI, or exit site/tunnel infection (ESI/TI).ResultsThe present study was stopped early due to an excess of catheter-related thrombosis in the sodium bicarbonate group. From the first 6 weeks of follow-up, there were no catheter losses due to CRT or CRBSI in both groups. The sodium bicarbonate group had a significantly higher rate of the secondary composite outcomes and this was entirely caused by CRT with the median time to thrombosis of 23.6 days. Every CRT event could be successfully rescued by using a single dose of recombinant tissue plasminogen activator (rt-PA).LimitationsShort follow-up period.ConclusionsIn prevalent HD patients with tunneled CVCs, use of a sodium bicarbonate locking solution for prevention of CRT is inferior to heparin and is associated with a high rate of catheter-related thrombosis.Trial registrationThe study was registered with the Thai Clinical Trials Registry TCTR 20200610003.

Project description:Background and objectivesEvidence to guide hemodialysis catheter locking solutions is limited. We aimed to assess effectiveness and cost of recombinant tissue plasminogen activator (rt-PA) once per week as a locking solution, compared with thrice weekly citrate or heparin, in patients at high risk of complications.Design, setting, participants, & measurementsWe used a prospective design and pre-post comparison in three sites across Canada. Pre-post comparisons were conducted using multilevel mixed effects regression models accounting for cluster with site and potential enrollment of patients more than once. In the pre period, catheter malfunction was managed as per site-specific standard of care. The intervention in the post period was once weekly rt-PA as a locking solution (with citrate or heparin used for other sessions). The primary outcome was rate of rt-PA use for treatment of catheter malfunction. Secondary outcomes included rates of bacteremia, management of catheter malfunction, and cost.ResultsThere were 374 patients (mean age 68 years; 52% men) corresponding to 506 enrollments. Mean length of enrollment was 200 days (SD 119) in the pre period and 187 days (SD 101) in the post period. There was a significant decline in rate of rt-PA use for treatment of catheter malfunction in the post compared with pre period (adjusted incidence rate ratio, 0.39; 95% confidence interval, 0.30 to 0.52); however, there was no difference in the rate of bacteremia, or catheter stripping or removal/replacement. The increase in mean total health care cost in the post period was CAD$962 per enrollment, largely related to costs of rt-PA as a locking solution.ConclusionsOnce weekly rt-PA as a catheter locking solution was associated with a reduction in rt-PA use for treatment of catheter malfunction. Our results showing a reduction in rescue rt-PA use are consistent with a prior randomized trial, although we did not observe a reduction in bacteremia or catheter stripping/removal and did observe an increased incremental cost of this strategy primarily accounted for by the cost of the rt-PA.

Dataset Information

Comparison of heparin to citrate as a catheter locking solution for non-tunneled central venous hemodialysis catheters in patients requiring renal replacement therapy for acute renal failure (VERROU-REA study): study protocol for a randomized controlled trial.

Publications

Comparison of heparin to citrate as a catheter locking solution for non-tunneled central venous hemodialysis catheters in patients requiring renal replacement therapy for acute renal failure (VERROU-REA study): study protocol for a randomized controlled trial.

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