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

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ClinicalTrials.gov Identifier: NCT03754361
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
First Hospital of China Medical University
Beijing Anzhen Hospital
The Luhe Teaching Hospital of the Capital Medical University
Ningbo No.2 Hospital
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
ESRD Procedure: automated peritoneal dialysis Procedure: IHD Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. infective morbidity [ Time Frame: At 14 days after the initiation of dialysis ]
    peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)


Secondary Outcome Measures :
  1. Mechanical complications morbidity [ Time Frame: At 14 and 90 days after the initiation of dialysis ]
    catheter leakage and migration (APD), catheter obstruction (IHD)， Exit site bleeding, pneumothorax, hernia

  2. dialysis related mortality [ Time Frame: At 14 and 90 days after the initiation of dialysis ]
    catheter-related:Sepsis, severe thromboembolic events (massive cerebral infarction, pulmonary embolism), arrhythmia (ventricular tachycardia, ventricular fibrillation),bleeding, Congestive heart failure and ischemic heart disease

  3. infective morbidity [ Time Frame: At 90 days after the initiation of dialysis ]
    peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754361


Contacts
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Contact: Haiyun Wang, MD +86-13671063539 wanghaiyun62926@126.COM
Contact: Peng Xia, MD +86-13811684903 7-xp@163.com

Locations
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China, Beijing
Beijing Anzhen Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100029
Contact: Guoqin Wang, MD, PhD    +86-13911282575    wangguoqin1@163.com   
Contact: Yumeng Zhang, BN    +86-13911992835    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         
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Haiyun Wang, MD    +86-13671063539    wanghaiyun62926@126.com   
Contact: Peng Xia, MD    +86-13811684903    7-xp@163.com   
Principal Investigator: Limeng Chen, MD, PhD         
Principal Investigator: Xuemei Li, MD, PhD         
Sub-Investigator: Peng Xia, MD         
Sub-Investigator: Ying Wang, MD, PhD         
Sub-Investigator: Haiyun Wang, MD, PhD         
Sub-Investigator: Bingyan Liu, MD, PhD         
Sub-Investigator: Zijuan Zhou, BN         
Beijing Luhe Hospital Affiliated to Capital Medical University Recruiting
Beijing, Beijing, China, 101149
Contact: Zhongxin Li, master    13621211613    13621211613@139.com   
Contact: Chunxia Shi, master    18701377094    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         
China, Liaoning
The First Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110001
Contact: Li Yao, MD, PhD    +86-13904035673    liyao_cmu@163.com   
Contact: Xinwang Zhu, MD, PhD    +86-13804056472    zhuxinwang_cmu@126.com   
Principal Investigator: Li Yao, MD, PhD         
Sub-Investigator: Xinwang Zhu, MD, PhD         
Sub-Investigator: Da Sun, MD, MM         
Sub-Investigator: Wei Wu, BN         
Sub-Investigator: Xiaoming Zhao, BN         
Sub-Investigator: Yanan Sun, BN         
China, Zhejiang
Ningbo No.2 Hospital Recruiting
Ningbo, Zhejiang, China, 315000
Contact: Kaiyue Wang, master    18867861568    nbwky1716@163.com   
Contact: Kedan Cai, bachelor    15857415082    caikedan_1983@126.com   
Principal Investigator: Qun Luo, master         
Sub-Investigator: Junfu Xu, bachelor         
Sub-Investigator: Fangfang Zhou, master         
Sponsors and Collaborators
Peking Union Medical College Hospital
First Hospital of China Medical University
Beijing Anzhen Hospital
The Luhe Teaching Hospital of the Capital Medical University
Ningbo No.2 Hospital
Investigators
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Principal Investigator: Limeng Chen, MD Division of Nephrology, Peking Union Medical College Hospital
More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03754361    
Other Study ID Numbers: URG-APD
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
urgent start dialysis
automated PD