PDF(Pubmed)
Abstract：
UNASSIGNED: Peritonitis is the leading complication of peritoneal dialysis (PD). Patients are instructed to seek care promptly for signs (cloudy effluent) or symptoms (abdominal pain), and earlier treatment improves outcomes. The CloudCath Peritoneal Dialysis Drain Set Monitoring (CloudCath) system monitors turbidity in dialysis effluent and sends notifications of changes signaling possible peritonitis.
UNASSIGNED: We conducted this single-arm, open-label, multicenter study of CloudCath system use during PD. We deactivated system notifications to participants and investigators, who followed standard-of-care for peritonitis signs and symptoms. Effectiveness endpoints measured time between CloudCath system notifications and peritonitis events using International Society of Peritoneal Dialysis (ISPD) criteria.
UNASSIGNED: Two hundred forty-three participants used the CloudCath system for 178.8 patient-years. Of 71 potential peritonitis events, 51 events (0.29 per patient-year) met ISPD white blood cell (WBC) count criteria. The system triggered notifications for 41 of 51 events (80.4%), with a median lead time of 2.6 days (10%-90% range, -1.0 to 15.7; P < 0.0001). Excluding 6 peritonitis events that occurred when the system was not in use, the system triggered notifications for 41 of 45 events (91.1%), with a median lead time of 3.0 days (10%-90% range, -0.5 to 18.8; P < 0.0001). Of the 0.78 notifications per patient-year, the majority were peritonitis events or nonperitonitis events such as exit site and tunnel infections or catheter/cycler issues.
UNASSIGNED: The CloudCath system detected peritonitis events during PD several days earlier than the current standard-of-care and has the capacity to send notifications that could expedite peritonitis diagnosis and treatment.
UNASSIGNED: We conducted this single-arm, open-label, multicenter study of CloudCath system use during PD. We deactivated system notifications to participants and investigators, who followed standard-of-care for peritonitis signs and symptoms. Effectiveness endpoints measured time between CloudCath system notifications and peritonitis events using International Society of Peritoneal Dialysis (ISPD) criteria.
UNASSIGNED: Two hundred forty-three participants used the CloudCath system for 178.8 patient-years. Of 71 potential peritonitis events, 51 events (0.29 per patient-year) met ISPD white blood cell (WBC) count criteria. The system triggered notifications for 41 of 51 events (80.4%), with a median lead time of 2.6 days (10%-90% range, -1.0 to 15.7; P < 0.0001). Excluding 6 peritonitis events that occurred when the system was not in use, the system triggered notifications for 41 of 45 events (91.1%), with a median lead time of 3.0 days (10%-90% range, -0.5 to 18.8; P < 0.0001). Of the 0.78 notifications per patient-year, the majority were peritonitis events or nonperitonitis events such as exit site and tunnel infections or catheter/cycler issues.
UNASSIGNED: The CloudCath system detected peritonitis events during PD several days earlier than the current standard-of-care and has the capacity to send notifications that could expedite peritonitis diagnosis and treatment.
摘要：
■腹膜炎是腹膜透析（PD）的主要并发症。指示患者迅速寻求护理的迹象（浑浊的流出物）或症状（腹痛），和早期治疗改善结果。CloudCath腹膜透析引流集监测(CloudCath)系统监测透析流出物中的浊度，并发送可能的腹膜炎信号的变化通知。
■我们进行了这种单臂，开放标签，PD期间CloudCath系统使用的多中心研究。我们停用了对参与者和调查人员的系统通知，遵循腹膜炎体征和症状的标准护理。使用国际腹膜透析协会(ISPD)标准测量CloudCath系统通知与腹膜炎事件之间的有效终点时间。
■二百四十三名参与者使用CloudCath系统178.8患者年。在71个潜在的腹膜炎事件中，51个事件（0.29/患者-年）符合ISPD白细胞（WBC）计数标准。系统触发了51个事件中的41个事件的通知（80.4%），中位提前期为2.6天(10%-90%范围，-1.0至15.7；P<0.0001）。不包括系统不使用时发生的6例腹膜炎事件，系统触发了45个事件中的41个事件的通知（91.1%），中位提前期为3.0天(10%-90%范围，-0.5至18.8；P<0.0001）。在每病人年0.78份通知中，大多数为腹膜炎事件或非腹膜炎事件,如出口部位和隧道感染或导管/循环仪问题.
■CloudCath系统在PD期间检测到腹膜炎事件的时间比当前的护理标准早几天，并且有能力发送可以加快腹膜炎诊断和治疗的通知。
■我们进行了这种单臂，开放标签，PD期间CloudCath系统使用的多中心研究。我们停用了对参与者和调查人员的系统通知，遵循腹膜炎体征和症状的标准护理。使用国际腹膜透析协会(ISPD)标准测量CloudCath系统通知与腹膜炎事件之间的有效终点时间。
■二百四十三名参与者使用CloudCath系统178.8患者年。在71个潜在的腹膜炎事件中，51个事件（0.29/患者-年）符合ISPD白细胞（WBC）计数标准。系统触发了51个事件中的41个事件的通知（80.4%），中位提前期为2.6天(10%-90%范围，-1.0至15.7；P<0.0001）。不包括系统不使用时发生的6例腹膜炎事件，系统触发了45个事件中的41个事件的通知（91.1%），中位提前期为3.0天(10%-90%范围，-0.5至18.8；P<0.0001）。在每病人年0.78份通知中，大多数为腹膜炎事件或非腹膜炎事件,如出口部位和隧道感染或导管/循环仪问题.
■CloudCath系统在PD期间检测到腹膜炎事件的时间比当前的护理标准早几天，并且有能力发送可以加快腹膜炎诊断和治疗的通知。
