The Study of Efficacy and Safety of Automated PD in Urgent Start Dialysis (URG-APD)

The Study of Efficacy and Safety of Automated Peritoneal Dialysis in Urgent Start Dialysis as Compared With Intermittent Hemodialysis in ESRD Patients,a Multi-center, Non-blind and Controlled Clinical Trial

This is a multi-center, controlled clinical trial study. The purpose of this study is to examine the efficacy and safety of automated peritoneal dialysis as compared with intermittent haemodialysis for ESRD patients with indications for urgent start dialysis.

Study Overview

• Status: Recruiting
• Conditions: ESRD
• Intervention / Treatment: Procedure: automated peritoneal dialysis; Procedure: IHD

Detailed Description

Hemodialysis（HD） and peritoneal dialysis (PD) are both the main methods to treat with end-stage renal disease (ESRD) uremia patients. The first 3-month mortality and hospitalization rate of new dialysis patient is much higher than that of regular dialysis's. So it is very important to set up dialysis pathway and from inducing dialysis into regular dialysis smoothly. But in the global 50-70%, more than 70% of the patients in China can not establish the dialysis pathway in advance according to the plan. With the common, a temporary deep venous catheter would be used first, then the fistula established later, as the final transition for hemodialysis. Urgent peritoneal dialysis can be established 24 hours after the establishment of permanent access dialysis, simply and easily, it can protect the residual kidney function; reduce treatment costs, hemodynamic stability, no anticoagulant is its unique advantages, At the same time, also avoid the temporary deep venous pathway prone to local bleeding, infection, venous thrombosis, central venous stenosis, direct impact on the future of the mature of fistula , or transplanted kidney vascular conditions. Automatic peritoneal dialysis (APD) in the treatment of urgent dialysis patients can save more manpower and resources, and improve the efficiency of peritoneal dialysis. The study on the efficacy and safety of urgent dialysis lacks the precisely designed multi-center, prospective and controlled clinical trial, and APD only induces 3 days, it is difficult to really reflect the safety and effectiveness of APD. Therefore, it is of great practical significance to study the difference of safety, efficacy and cost-effectiveness between urgent PD and HD in a prospective, control and multicenter clinical trial. 206 ESRD uremia patients will involve in this multi-center, prospective and controlled clinical trial, the mode of urgent dialysis will choose by patient guided by nephrologist, the HD group will receive the standard traditional treatment: from induction HD to regular HD. The PD group will receive the APD daily. All patient will be monitor the physiological and biochemical marker for 14 day, and all adverse events and dead within 90days will collected to evaluated the safety, efficacy of the two urgent dialysis modes.

• Study Type: Interventional
• Enrollment (Anticipated): 206
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haiyun Wang, MD; Phone Number: +86-13671063539; Email: wanghaiyun62926@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Haiyun Wang, MD; Phone Number: +86-13671063539; Email: wanghaiyun62926@126.com
      • Principal Investigator: Xuemei Li, MD, PhD
      • Sub-Investigator: Ying Wang, MD, PhD
      • Sub-Investigator: Haiyun Wang, MD, PhD
      • Sub-Investigator: Bingyan Liu, MD, PhD
      • Sub-Investigator: Zijuan Zhou, BN
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital, Capital Medical University
      • Contact: Guoqin Wang, MD, PhD; Phone Number: +86-13911282575; Email: wangguoqin1@163.com
      • Contact: Yumeng Zhang, BN; Phone Number: +86-13911992835; Email: 791751665@qq.com
      • Principal Investigator: Hong Cheng, MD, PhD
      • Sub-Investigator: Guoqin Wang, MD, PhD
      • Sub-Investigator: Zhirui Zhao, MD
      • Sub-Investigator: Yu Wang, BN
      • Sub-Investigator: Yumeng Zhang, BN
    • Beijing, Beijing, China, 101149
      • Recruiting
      • Beijing Luhe Hospital affiliated to Capital Medical University
      • Contact: Zhongxin Li, master; Phone Number: 13621211613; Email: 13621211613@139.com
      • Contact: Chunxia Shi, master; Phone Number: 18701377094; Email: 422601904@qq.com
      • Principal Investigator: Zhongxin Li, master
      • Sub-Investigator: Chunxia Shi, master
      • Sub-Investigator: Yanan Shi, bachelor
      • Sub-Investigator: Conghui Liu, master
      • Sub-Investigator: Qianying Cao, master
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Recruiting
      • The First Hospital of China Medical University
      • Contact: Li Yao, MD, PhD; Phone Number: +86-13904035673; Email: liyao_cmu@163.com
      • Sub-Investigator: Da Sun, MD, MM
      • Sub-Investigator: Wei Wu, BN
      • Sub-Investigator: Xiaoming Zhao, BN
      • Sub-Investigator: Yanan Sun, BN
  • Zhejiang
    • Ningbo, Zhejiang, China, 315000
      • Recruiting
      • Ningbo No.2 Hospital
      • Contact: Kaiyue Wang, master; Phone Number: 18867861568; Email: nbwky1716@163.com
      • Contact: Kedan Cai, bachelor; Phone Number: 15857415082; Email: caikedan_1983@126.com
      • Principal Investigator: Qun Luo, master
      • Sub-Investigator: Junfu Xu, bachelor
      • Sub-Investigator: Fangfang Zhou, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• CKD(chronic kidney disease)-5 stage patient whose eGFR（CKD-EPI（chronic kidney disease-epidemiology collaboration））<15 ml/min/1.73m2,occured uremic symptoms or volume overload need of renal replacement therapy(RRT) within 14 days .
• Prolonged RRT access is not available.
• No dialysis treatment was given within 1 months.
• The vital signs are stable and tolerable in peritoneal dialysis catheterization or central venous catheterization.
• Able to understand the whole process of the trial, voluntarily participate in and sign informed consent.

Exclusion Criteria:

• Maintenance RRT alraedy.
• Serious metabolic disorders ( hyperkalemia and acidosis) cause significant changes in electrocardiogram or other emergency indications to RRT within 24 hours.
• Hypertensive emergencies(diastolic blood pressure>130mmHg)
• Severe respiratory, circulatory or hepatic failure requires instrumental support or vasoactive drugs to maintain vital signs.
• High catabolic state eg. severe inflammation or trauma
• Absolute contraindication of peritoneal dialysis such as recent abdominal surgery (<1month), multiple abdominal surgeries.
• Absolute contraindication for hemodialysis such as hemodynamic instability (systolic blood pressure <80mmHg).
• Pregnant.
• Expected to survive for less than 1 years.
• Plan for kidney transplantation within 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: APD group; Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment	Procedure: automated peritoneal dialysis; peritoneal dialysis administered by a cycler
ACTIVE_COMPARATOR: IHD group; Subjects will receive un-tunneled hemodialysis catheter placement and subsequent hemodialysis treatment 3-4 times per week,2-4 hours each time.	Procedure: IHD; HD 4hour 2-3times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
infective morbidity	peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)	At 14 days after the initiation of dialysis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical complications morbidity	catheter leakage and migration (APD), catheter obstruction (IHD)， Exit site bleeding, pneumothorax, hernia	At 14 and 90 days after the initiation of dialysis
dialysis related mortality	catheter-related:Sepsis, severe thromboembolic events (massive cerebral infarction, pulmonary embolism), arrhythmia (ventricular tachycardia, ventricular fibrillation),bleeding, Congestive heart failure and ischemic heart disease	At 14 and 90 days after the initiation of dialysis
infective morbidity	peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)	At 90 days after the initiation of dialysis

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Anzhen Hospital; First Hospital of China Medical University; The Luhe Teaching Hospital of the Capital Medical University; Ningbo No.2 Hospital
• Investigators: Principal Investigator: Limeng Chen, MD, Division of Nephrology, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): February 28, 2023

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (ACTUAL): November 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: urgent start dialysis; automated PD
• Other Study ID Numbers: URG-APD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No