慢性肾脏病-腹膜透析（CKD-PD）应用程序对腹膜透析患者水钠潴留治疗改善效果的随机对照试验

Effect of the Chronic Kidney Disease-Peritoneal Dialysis (CKD-PD) App on Improvement of Overhydration Treatment in Patients on Peritoneal Dialysis: Randomized Controlled Trial.

作者信息

Anutrakulchai Sirirat, Tatiyanupanwong Sajja, Kananuraks Sarassawan, Lukkanalikitkul Eakalak, Kongpetch Sawinee, Chotmongkol Wijittra, Morley Michael G, Thinkhamrop Wilaiphorn, Thinkhamrop Bandit, Kleebchaiyaphum Chadarat, Khianchanach Krongsin, Chunghom Theenatchar, Morley Katharine E

机构信息

Division of Nephrology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.

Kidney Unit, Department of Internal Medicine, Chaiyaphum Hospital, Chaiyaphum, Thailand.

出版信息

J Med Internet Res. 2025 May 21;27:e70641. doi: 10.2196/70641.

DOI:10.2196/70641

PMID:40397925

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12138318/

Abstract

BACKGROUND

Overhydration is associated with increased morbidity and mortality in patients on peritoneal dialysis (PD). Early detection of overhydration is possible by monitoring hydration metrics, but the critical gap for treatment is obtaining timely and actionable data.

OBJECTIVE

This study compares the detection of overhydration and clinical outcomes in patients on PD using the Chronic Kidney Disease-Peritoneal Dialysis (CKD-PD) smartphone app with standard monitoring and management.

METHODS

An open-label randomized controlled trial was conducted at 3 hospitals in northeast Thailand. Enrolled participants from PD clinics were randomized into 2 equal groups: CKD-PD (App users) and usual management (No-App). Participants or their caregivers in the App group recorded hydration metrics in the CKD-PD app, which were uploaded to a central database monitored by nephrology staff. The No-App group used a handwritten logbook. Both groups had bimonthly clinic visits. The primary outcome was the incidence rate ratio (IRR) for clinical interventions for overhydration. Secondary outcomes included hospitalizations, technique failure, and death.

RESULTS

A total of 208 participants were randomized into App (N=103) and No-App (N=105) groups with the median follow-up time of 11.2 months. Hydration metric upload compliance in the App group was 85.7% (IQR 71.4-95.6). The IRR of overall interventions for overhydration was 2.51 times higher in the App group (95% CI 2.18-2.89; P<.001). Types of clinical interventions for overhydration differed between groups with dietary change and prescription of antihypertensive drugs more frequent in App users and diuretics and change of dialysis prescription more frequent in the No-App group. Hospitalizations were significantly higher in the No-App group due to any cause (adjusted IRR 1.58) and volume overload (adjusted IRR 4.07). There was no significant difference in survival analysis and technique failure between the 2 groups.

CONCLUSIONS

Use of the CKD-PD app improved early detection of overhydration and early treatment interventions, resulting in fewer all-cause and volume overload hospitalizations.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04797195; https://clinicaltrials.gov/study/NCT04797195.

摘要

背景

水钠潴留与腹膜透析（PD）患者的发病率和死亡率增加相关。通过监测水化指标可以早期发现水钠潴留，但治疗的关键差距在于获取及时且可采取行动的数据。

目的

本研究比较了使用慢性肾脏病 - 腹膜透析（CKD - PD）智能手机应用程序与标准监测和管理方法对PD患者水钠潴留的检测及临床结局。

方法

在泰国东北部的3家医院进行了一项开放标签随机对照试验。从PD诊所招募的参与者被随机分为2个相等的组：CKD - PD（应用程序用户）组和常规管理（无应用程序）组。应用程序组的参与者或其护理人员在CKD - PD应用程序中记录水化指标，这些指标被上传到由肾脏病学工作人员监测的中央数据库。无应用程序组使用手写日志。两组均每两个月进行一次门诊就诊。主要结局是水钠潴留临床干预的发病率比（IRR）。次要结局包括住院、技术失败和死亡。

结果

总共208名参与者被随机分为应用程序组（N = 103）和无应用程序组（N = 105），中位随访时间为11.2个月。应用程序组的水化指标上传依从率为85.7%（四分位间距71.4 - 95.6）。应用程序组水钠潴留总体干预的IRR高2.51倍（95%CI 2.18 - 2.89；P <.001）。两组水钠潴留的临床干预类型不同，应用程序用户中饮食改变和抗高血压药物处方更频繁，无应用程序组中利尿剂和透析处方改变更频繁。无应用程序组因任何原因导致的住院率显著更高（调整后的IRR 1.58）和容量超负荷住院率（调整后的IRR 4.07）。两组在生存分析和技术失败方面无显著差异。