Urgent-start Peritoneal Dialysis in ESRD Patients：A Multi-center Study

December 1, 2023 updated by: RenJi Hospital

Urgent-start Peritoneal Dialysis to Improve Treatment in ESRD Patients：A Multi-center Clinical Tial

Within the last decade, urgent-start peritoneal dialysis(PD) has gained considerable interest amongst nephrologists. Several publications have provided assurances that urgent-start PD is indeed feasible and can serve patients well; however, most of the studies have small sample sizes, retrospective design, and the impact of the urgent-start dialysis modality on outcome, especially on short-term complications, has not been directly evaluated. Therefore, we started this multi-centered, prospective, interventional study compared the dialysis-related complications and survival rate directly between urgent-start PD and HD groups with a large sample to determine the feasibility and safety of urgent-start PD as an alternate initial modality of dialysis for patients who require urgent initiation of dialysis therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of chronic kidney disease (CKD) and end-stage renal disease (ESRD) is on the rise worldwide. Moreover, many patients who progress to ESRD, even with regular nephrology follow-up, do not have a distinct plan at the time of initiating dialysis therapy, resulting in an urgent need for dialysis. Urgent-start dialysis refers to urgent initiation of dialysis for ESRD patients with no pre-established functional vascular access or peritoneal dialysis (PD) catheter. Hemodialysis (HD) is preferred in most centers with a high rate of central venous catheter (CVC) use at the time of initiating dialysis among HD patients. There is a significantly increased risk of infectious complications, thrombosis, and other complications associated with CVC use which negatively affects patient prognosis. Within the last decade, urgent-start PD has gained considerable interest amongst nephrologists. Several publications have provided assurances that urgent-start PD is indeed feasible and can serve patients well; however, most of the studies have small sample sizes, and the impact of the urgent-start dialysis modality on outcome, especially on short-term complications, has not been directly evaluated. Therefore, we conducted this multicenter, prospective, randomized clinical trial to compare the dialysis-related complications and survival rate directly between urgent-start PD and HD groups with a large sample to determine the feasibility and safety of urgent-start PD as an alternate initial modality of dialysis for patients who require urgent initiation of dialysis therapy.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Renji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

Patients will be eligible to be included in the study only if all of the following criteria are applicable:

  1. Age d 18-80 years at the time of signing the informed consent;
  2. Diagnosed as ESRD;
  3. Requiring urgent initiation of dialysis due to late presentation or rapid progression of renal disease without a pre-established functional dialysis access;
  4. Capable of giving signed informed consent.

Exclusion criteria:

Patients will be excluded from the study if any of the following criteria are applicable:

  1. patients with severe volume overload with pulmonary edema;
  2. patients with severe hyperkalemia (>6.5 mmol/L);
  3. patients with uremia encephalopathy;
  4. patients with severe liver failure;
  5. patients with uncorrectable shock;

(5)patients with severe risk of bleeding or hemorrhagic disease; (6)patients with contraindications of PD including extensive peritoneal fibrosis adhesion, severe skin disease, extensive abdominal infection or extensive abdominal burns, uncorrectable mechanical problems such as herniation of the umbilicus, herniation of the abdomen, bifida of the bladder, valgus of the peritoneum, peritoneal cavity and chest leakage; (7)patients with Intracranial hemorrhage or increased intracranial pressure; (8)patients with uncorrectable shock; (9)patients who cannot establish a vascular access; (10)patients with malignancy; (11)patients with mental disorder; (12)patients with pregnancy or lactation; (13)patients unable or unwilling to provide informed consent for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: urgent-start peritoneal dialysis
All patients in urgent-start peritoneal dialysis arm initiate peritoneal dialysis as urgent-start dialysis modality.
Device: urgent-start peritoneal dialysis catheter
Patients initiated peritoneal dialysis as urgent-start dialysis modality with a peritoneal dialysis catheter.
Active Comparator: urgent-start hemodialysis
All patients in urgent-start hemodialysis arm initiate hemodialysis as urgent-start dialysis modality.
Device: central venous catheter
Patients initiated hemodialysis as urgent-start dialysis modality with a central venous catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of dialysis-related complications
Time Frame: 12 months
the incidence of dialysis-related complications.Dialysis-related complications were defined as a composite of non-infectious complications (malposition, obstruction, leakage, hernia, bleeding, or thrombosis) and infectious complications (catheterrelated infection, exit-site infection, or peritonitis)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PD catheter technical survival rate
Time Frame: 12 months
PD catheter technical survival rate
12 months
peritonitis-free survival rates
Time Frame: 12 months
peritonitis-free survival rates
12 months
patient survival rate
Time Frame: 12 months
patient survival rate
12 months
total medical cost of initial hospitalization
Time Frame: 6 weeks
total medical cost of initial hospitalization
6 weeks
duration of initial hospitalization
Time Frame: 6 weeks
duration of initial hospitalization
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Changhai Hospital
Ruijin Hospital
Shanghai Tong Ren Hospital
Shanghai University of Traditional Chinese Medicine
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai Songjiang District Central Hospital
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Shanghai Jiading District Central Hospital
Xin Hua Hospital
Shanghai Punan Hospital

Investigators

  • Study Chair: Zhaohui Ni, Doctor, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
  • Principal Investigator: Gengru Jiang, Doctor, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Principal Investigator: Niansong Wang, Doctor, The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
  • Principal Investigator: Zhiyong Guo, Doctor, Changhai Hospital
  • Principal Investigator: Xiaonong Chen, Doctor, Ruijin Hospital
  • Principal Investigator: Feng Ding, Doctor, No.9 People Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Principal Investigator: Weijie Yuan, Doctor, Shanghai General Hospital affiliated to Shanghai Jiao Tong University
  • Principal Investigator: Yueyi Deng, Doctor, Long Hua Hospital Shanghai University of Traditional Chinese Medicine
  • Principal Investigator: Xiaoxia Wang, Tong Ren Hospital Shanghai Jiao Tong University school of medicine
  • Principal Investigator: Ying Li, Jiading district central hospital of Shanghai
  • Principal Investigator: Xiujuan Zang, hanghai Songjiang District Central Hospital
  • Principal Investigator: Guoqing Wu, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2019

Primary Completion (Actual)

November 17, 2021

Study Completion (Actual)

November 17, 2021

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimated)

October 27, 2016

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJ20161021USPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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