Department of Nephrology, NYC Health + Hospitals/Coney Island, Brooklyn, NY, USA.
Department of Medicine, NYC Health + Hospitals/Coney Island, Brooklyn, NY, USA.
Nephrol Dial Transplant. 2019 Oct 1;34(10):1739-1745. doi: 10.1093/ndt/gfy388.
There is no ideal lock solution that prevents hemodialysis (HD) catheter loss due to catheter-related thrombosis (CRT) and catheter-related bloodstream infection (CRBSI). Catheter loss is associated with increased hospitalization and high inpatient costs. Sodium bicarbonate (NaHCO3) demonstrates anti-infective and anticoagulation properties with a good safety profile, making it an ideal lock solution development target.The objective of this study was to determine the safety and efficacy of using sodium bicarbonate catheter lock solution (SBCLS) as a means of preventing HD catheter loss due to CRT and CRBSI.
The study took place in a community hospital in Brooklyn, NY, USA. All admitted patients ≥18 years of age who needed HD treatment through CVC were included in the study. 451 patients included in the study were provided SBCLS or NSCLS post-dialysis. Catheter loss due to CRT or CRBSI was evaluated over a period of 546 days.
A total of 452 patients met the criteria; 1 outlier was excluded, 226 were in the NSCLS group and 225 were in the SBCLS group. There were no significant differences between groups in comorbidities at the outset. The NSCLS group had CRT and CRBSI rates of 4.1 and 2.6/1000 catheter days (CD), respectively, compared with 0.17/1000 CD for both outcomes in the SBCLS group. SBCLS patients had a significantly reduced catheter loss rate due to CRT (P < 0.0001) and CRBSI (P = 0.0004). NSCLS patients had higher odds of losing their catheter due to CRT {odds ratio [OR] 26.6 [95% confidence interval (CI) 3.57-198.52]} and CRBSI [OR 15.9 (95% CI 2.09-121.61)] during the study period.
The novel approach of using SBCLS was found to be safe and was statistically superior to normal saline in preventing HD catheter loss due to CRT and CRBSI. NaHCO3 solution is inexpensive, readily available in various settings and holds the potential to decrease hospitalization, length of stay and dialysis-related costs.
Maimonides Medical Center Investigational Review Board, Study IRB 2015-06-25-CIH. ClinicalTrials.gov identifier: NCT03627884.
目前尚无理想的锁闭溶液可以预防因导管相关血栓形成（CRT）和导管相关血流感染（CRBSI）导致的血液透析（HD）导管丢失。导管丢失与住院时间延长和住院费用增加有关。碳酸氢钠（NaHCO3）具有抗感染和抗凝作用，安全性良好，是理想的锁闭溶液开发目标。本研究旨在确定使用碳酸氢钠导管锁闭溶液（SBCLS）作为预防因 CRT 和 CRBSI 导致 HD 导管丢失的方法的安全性和有效性。
本研究在美国纽约布鲁克林的一家社区医院进行。所有需要通过中心静脉导管（CVC）进行 HD 治疗的≥18 岁入院患者均纳入本研究。在研究期间，451 名患者在透析后接受 SBCLS 或 NSCLS。在 546 天的时间里，评估因 CRT 或 CRBSI 导致的导管丢失情况。
共有 452 名患者符合标准；排除 1 名离群值，226 名患者在 NSCLS 组，225 名患者在 SBCLS 组。两组患者在开始时的合并症方面无显著差异。NSCLS 组 CRT 和 CRBSI 的发生率分别为 4.1 和 2.6/1000 导管日（CD），而 SBCLS 组分别为 0.17/1000 CD。SBCLS 患者因 CRT 导致的导管丢失率显著降低（P<0.0001）和 CRBSI（P=0.0004）。在研究期间，NSCLS 患者因 CRT（优势比 [OR] 26.6 [95%置信区间 （CI） 3.57-198.52]）和 CRBSI（OR 15.9 [95% CI 2.09-121.61]）丢失导管的可能性更高。
使用 SBCLS 的新方法被发现是安全的，并且在预防因 CRT 和 CRBSI 导致的 HD 导管丢失方面统计学上优于生理盐水。碳酸氢钠溶液价格低廉，在各种环境中均可获得，具有降低住院时间、住院时间和透析相关费用的潜力。
Maimonides 医疗中心调查审查委员会，研究 IRB 2015-06-25-CIH。ClinicalTrials.gov 标识符：NCT03627884。
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