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4%枸橼酸钠与肝素作为危重症患者非隧道式血液透析导管封管液的比较:一项多中心随机临床试验

Trisodium citrate 4% versus heparin as a catheter lock for non-tunneled hemodialysis catheters in critically ill patients: a multicenter, randomized clinical trial.

作者信息

Quenot Jean-Pierre, Helms Julie, Bourredjem Abderrahmane, Dargent Auguste, Meziani Ferhat, Badie Julio, Blasco Gilles, Piton Gaël, Capellier Gilles, Mezher Chaouki, Rebibou Jean-Michel, Nadji Abdelouaid, Crepin Thomas, Barbar Saber Davide, Fleck Camille, Cransac Amélie, Boulin Mathieu, Binquet Christine, Soudry-Faure Agnès, Bruyère Rémi

机构信息

Service de Médecine Intensive-Réanimation, Centre Hospitalier Universitaire Dijon Bourgogne, 14 rue Paul Gaffarel, B.P 77908, 21079, Dijon Cedex, France.

Université Bourgogne Franche-Comté, Lipness Team UMR 1231 et LabExLipSTIC, 21000, Dijon, France.

出版信息

Ann Intensive Care. 2019 Jul 1;9(1):75. doi: 10.1186/s13613-019-0553-4.

Abstract

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.

摘要

背景

目前,非隧道式血液透析导管用于需要体外肾脏替代治疗的急性肾损伤重症患者。使用导管封管预防导管功能障碍和感染的策略仍存在争议。

方法

在一项多中心、随机、对照、双盲试验中,我们比较了两种非隧道式血液透析导管封管策略,即4%枸橼酸钠(干预组)与普通肝素(对照组),纳入入住重症监护病房且年龄在18岁及以上、首次通过颈内静脉或股静脉插入非隧道式血液透析导管的患者。主要终点是第一根非隧道式血液透析导管无事件生存时长。次要终点包括:每1000导管日的纤维蛋白溶解率、导管功能障碍发生率和导管相关血流感染(CRBSI)发生率;需要输血的出血事件数量、重症监护病房住院时长和住院总时长;28天死亡率。

结果

总体而言,396例随机分组患者完成了试验:枸橼酸钠组199例,肝素组197例。两组基线特征无显著差异。两组第一根非隧道式血液透析导管的无事件生存时长无显著差异:枸橼酸钠组为7天(四分位间距3 - 10天),肝素组为5天(四分位间距3 - 11天)(p = 0.51)。两组间导管血栓形成率、CRBSI和不良事件发生率无统计学差异。

结论

在重症患者中,4%枸橼酸钠和肝素作为封管溶液时,第一根非隧道式血液透析导管的无事件生存时长无显著差异。两组间导管血栓形成、导管相关感染和不良事件无统计学差异。试验注册 在Clinicaltrials.gov上注册,注册号为NCT01962116。2013年10月14日注册。

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