Data from: Adverse events related to intravenous antibiotic therapy: a prospective observational study in the treatment of infective endocarditis

Objective: The goal of this prospective observational present study was to identify adverse events (AEs) related to the use of intravenous access sites for infective endocarditis (IE) treatment in a tertiary care hospital that can occur during patient care that cannot be attributed to the underlying disease and may result in lengthening of hospital stay or death. Design: This is an observational, analytical and prospective study on AEs resulting from the use of intravenous access sites in patients under antimicrobial treatment for IE. Patients enrolled in the International Collaboration on Endocarditis (ICE) study had their peripheral, short term central catheters (CVC) and peripherally inserted central catheters (PICC) monitored for AEs. Setting: Tertiary care hospital for cardiac surgery in Rio de Janeiro, Brazil. Patients: Patients over 18 years of age, hospitalized in 2009 and 2010 with definite criteria for IE by the modified Duke criteria were included. Main outcome measures: Adverse events related to intravenous catheters: erythema and infiltration, fever, obstruction, externalization and blood stream infection. Results: Thirty-seven episodes of IE in 35 patients were studied. Mean age was 44.32 ± 15.2 years; 22 (63%) were male. 253 vascular catheters were studied, 148 peripheral, 85 CVC (21 of which for haemodialysis) and 20 PICC. The most frequent AEs were “erythema” and “infiltration” for peripheral catheters, “fever” for CVCs, and “obstruction” and “externalization” for PICCs. The number of catheter-days was 360 for peripheral catheters, 1.156 for CVC and 420 for PICC. Kaplan Meier curves for CVC and PICC showed statistical difference for obstruction (p<0.001) in PICCs. More bacteraemia occurred in CVC compared to PICC. Conclusion: The choice of intravenous access sites is critical in the treatment of IE. Close observation for adverse events and stricter implementation of infection control measures and better manipulation of catheters are suggested.

研究目的：本前瞻性观察性研究旨在识别巴西某三级医院内，接受感染性心内膜炎（infective endocarditis, IE）治疗时，静脉通路相关不良事件（adverse events, AEs）——此类事件可发生于患者诊疗过程中，需排除由基础疾病导致，且可能延长患者住院时长或引发死亡。
研究设计：本研究为观察性分析类前瞻性研究，针对接受抗菌药物治疗的感染性心内膜炎患者，其静脉通路使用相关不良事件展开分析。纳入国际心内膜炎协作研究（International Collaboration on Endocarditis, ICE）的受试者，其外周短时间中心静脉导管（central venous catheter, CVC）及经外周置入中心静脉导管（peripherally inserted central catheter, PICC）的不良事件均被纳入监测范围。
研究场景：巴西里约热内卢某心脏外科三级医院。
研究对象：2009年至2010年住院、符合改良杜克标准确诊感染性心内膜炎、年龄≥18岁的患者。
主要结局指标：静脉导管相关不良事件包括"红斑"与"浸润"、发热、导管堵塞、导管脱出及血流感染。
研究结果：本研究共纳入35例患者的37例感染性心内膜炎诊疗事件。受试者平均年龄为44.32±15.2岁，其中男性22例，占比63%。共纳入253根血管导管：其中外周导管148根、中心静脉导管85根（含21根用于血液透析）、经外周置入中心静脉导管20根。外周导管最常见的不良事件为"红斑"与"浸润"，中心静脉导管最常见的不良事件为"发热"，经外周置入中心静脉导管最常见的不良事件为"堵塞"与"脱出"。外周导管的总留置天数为360天，中心静脉导管为1156天，经外周置入中心静脉导管为420天。中心静脉导管与经外周置入中心静脉导管的卡普兰-迈耶（Kaplan-Meier）曲线显示，经外周置入中心静脉导管的堵塞事件发生率存在显著统计学差异（p<0.001）。中心静脉导管的菌血症发生率高于经外周置入中心静脉导管。
研究结论：静脉通路的选择在感染性心内膜炎治疗中至关重要。本研究建议加强不良事件监测、严格落实感染防控措施，并优化导管操作流程。