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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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End-Stage Renal Disease

Intervention / Treatment
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* Device: urgent-start peritoneal dialysis catheter
* Device: central venous catheter


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients will be eligible to be included in the study only if all of the following criteria are applicable: Age d 18-80 years at the time of signing the informed consent; Diagnosed as ESRD; Requiring urgent initiation of dialysis due to late presentation or rapid progression of renal disease without a pre-established functional dialysis access; Capable of giving signed informed consent. Exclusion criteria: Patients will be excluded from the study if any of the following criteria are applicable: patients with severe volume overload with pulmonary edema; patients with severe hyperkalemia (>6.5 mmol/L); patients with uremia encephalopathy; patients with severe liver failure; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of dialysis-related complications | 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 | PD catheter technical survival rate | 12 months | 
| peritonitis-free survival rates | peritonitis-free survival rates | 12 months | 
| patient survival rate | patient survival rate | 12 months | 
| total medical cost of initial hospitalization | total medical cost of initial hospitalization | 6 weeks | 
| duration of initial hospitalization | duration of initial hospitalization | 6 weeks |