Dataset Information

A Randomized Controlled Trial of Comparative Efficacy between Sodium Bicarbonate and Heparin as A Locking Solution for Tunneled Central Venous Catheters Among Patients Requiring Maintenance Hemodialysis.

ABSTRACT:

Background

Sodium 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.

Objective

To 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.

Design

A multicenter, randomized, open-label study.

Setting

In a developing country, Thailand.

Patients

Chronic HD patients with tunneled central venous catheter.

Measurements

Catheter loss rate, rate of catheter-related blood stream infection, catheter-related thrombosis, and exit site or tunnel infection.

Methods

The 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).

Results

The 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).

Limitations

Short follow-up period.

Conclusions

In 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 registration

The study was registered with the Thai Clinical Trials Registry TCTR 20200610003.

SUBMITTER: Wathanavasin W

PROVIDER: S-EPMC8488503 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description: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.

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:BACKGROUND:Peripheral venous catheters (PVCs) require adequate maintenance based on heparin or saline locks in order to prevent complications. Heparin has proven effective in central venous catheters, although its use in PVCs remains controversial. Our hypothesis was that saline locks are as effective as heparin locks in preventing problems with PVCs. The objective of the present study was to compare phlebitis and catheter tip colonization rates between PVCs locked with saline and those locked with heparin in patients admitted to an internal medicine department (IMD). METHODS:We performed a 19-month prospective, controlled, open-label, randomized clinical study of patients with at least 1 PVC admitted to the IMD of our hospital. The patients were randomized to receive saline solution (PosiFlush®, group A) or heparin (Fibrilin®, group B) for daily maintenance of the PVC. Clinical and microbiological data were monitored to investigate the frequency of phlebitis, catheter tip colonization, and catheter-related bloodstream infection (C-RBSI), as well as crude mortality, days of hospital stay, and days of antimicrobial treatment. RESULTS:We assessed 339 PVCs (241 patients), of which 192 (56.6%) were locked with saline (group A) and 147 (43.4%) with heparin (group B). The main demographic characteristics of the patients were distributed equally between the 2 study groups. The median (IQR) catheter days was 5 (3-8) for both groups (p = 0.64). The frequency of phlebitis was 17.7% for group A and 13.3% for group B (p = 0.30). The frequency of colonization of PVC tips was 14.6% and 12.2% in groups A and B, respectively (p = 0.63). Only 2 episodes of C-RBSI were detected (1 patient in group A). Saline lock was not an independent factor for phlebitis or catheter colonization. CONCLUSIONS:Our study revealed no statistically significant differences in the frequency of phlebitis and catheter tip colonization between PVCs locked with saline and PVCs locked with heparin. We suggest that PVC can be maintained with saline solution, as it is safer and cheaper than heparin.

Project description:BackgroundDespite well-publicized suggestions to utilize arteriovenous fistulae and grafts to initiate hemodialysis, too many patients in the United States start dialysis via central venous catheters despite their well-known association with increased morbidity, mortality, and cost.MethodsTo determine the reasons for this high rate of catheter use, and, ultimately, ways to reduce it, we developed a questionnaire designed to determine where in the process of patient care the process to fistula or graft placement was not completed, thus requiring the use of central venous catheters. The questionnaire was reviewed by several nephrologists not involved with the study. We administered the questionnaire to 52 consecutive hospitalized patients who started maintenance dialysis with catheters at a University-affiliated Hospital and referral center. The questionnaire asked each patient to provide details pertaining to pre-dialysis care, referrals, and follow-through on recommended referrals. If the patient did not see the physician to whom he/she was referred, we asked the reason(s) for such failure.ResultsPatient responses showed that there were two major lapses in the transition from diagnosis of advanced kidney disease to construction of appropriate dialysis access: failure by the patients to see a nephrologist and/or an access surgeon, and failure by physicians to refer patients to an access surgeon. Twenty percent of the patients failed to follow up with either a nephrologist or a surgeon. Only 38% (15/40) of those seen by a nephrologist had been referred to a surgeon.ConclusionsThe quality of care was impaired by lack of referral to surgeons by nephrologists and by lack of follow-through by patients. Areas for improvement include improved communications between physicians and patients and more careful follow-up by both physicians and patients. Several methods of providing better patient care and communication between patients and nephrologists are recommended.