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

Not Applicable

Completed

• Conditions: End-Stage Renal Disease
• Interventions: Device: urgent-start peritoneal dialysis catheter; Device: central venous catheter

• Registration Number: NCT02946528
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Study Start: 2019-02-26
• Primary Completion: 2021-11-17
• Study Completion: 2021-11-17
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
urgent-start peritoneal dialysis	urgent-start peritoneal dialysis catheter	All patients in urgent-start peritoneal dialysis arm initiate peritoneal dialysis as urgent-start dialysis modality.
urgent-start hemodialysis	central venous catheter	All patients in urgent-start hemodialysis arm initiate hemodialysis as urgent-start dialysis modality.

Primary Outcome Measures

Name	Time	Method
the incidence of dialysis-related complications	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)

Secondary Outcome Measures

Name	Time	Method
peritonitis-free survival rates	12 months	peritonitis-free survival rates
PD catheter technical survival rate	12 months	PD catheter technical survival rate
total medical cost of initial hospitalization	6 weeks	total medical cost of initial hospitalization
patient survival rate	12 months	patient survival rate
duration of initial hospitalization	6 weeks	duration of initial hospitalization

Trial Locations

Locations (1)

RenJi Hospital; 🇨🇳 Shanghai, China