The Study of Efficacy and Safety of Automated PD in Urgent Start Dialysis

NCT03754361 | Terminated

• 1 other identifier: URG-APD
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 5

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.

Conditions

ESRD

Keywords

urgent start dialysis; automated PD

Outcome Measures

Primary Outcomes (1)

• infective morbidity

  peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)

  At 14 days after the initiation of dialysis

Secondary Outcomes (3)

• Mechanical complications morbidity

  At 14 and 90 days after the initiation of dialysis

• dialysis related mortality

  At 14 and 90 days after the initiation of dialysis

• infective morbidity

  At 90 days after the initiation of dialysis

Study Arms (2)

APD group

EXPERIMENTAL

Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment

Procedure: automated peritoneal dialysis

IHD group

ACTIVE COMPARATOR

Subjects will receive un-tunneled hemodialysis catheter placement and subsequent hemodialysis treatment 3-4 times per week,2-4 hours each time.

Procedure: IHD

Interventions

automated peritoneal dialysis PROCEDURE

peritoneal dialysis administered by a cycler

APD group

IHD PROCEDURE

HD 4hour 2-3times per week

IHD group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• First Hospital of China Medical University: collaborator
• Beijing Anzhen Hospital: collaborator
• The Luhe Teaching Hospital of the Capital Medical University: collaborator
• Ningbo No.2 Hospital: collaborator

Study Sites (5)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing Luhe Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 101149, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Ningbo No.2 Hospital

Ningbo, Zhejiang, 315000, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Limeng Chen, MD

  Division of Nephrology, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 27, 2018
• Study Start: January 1, 2019
• Primary Completion: July 31, 2022
• Study Completion: December 28, 2022
• Last Updated: June 8, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)