Skip to main content
OpenTrials
Completed

NCT Number: NCT02946528

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

urgent-start peritoneal dialysis catheter

Device

Patients initiated peritoneal dialysis as urgent-start dialysis modality with a peritoneal dialysis catheter.

Central Venous Catheter

Device

Patients initiated hemodialysis as urgent-start dialysis modality with a central venous catheter.

Primary outcomes

  1. 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)

Secondary outcomes

  1. PD catheter technical survival rate

    Time frame: 12 months

    PD catheter technical survival rate

  2. peritonitis-free survival rates

    Time frame: 12 months

    peritonitis-free survival rates

  3. patient survival rate

    Time frame: 12 months

    patient survival rate

  4. total medical cost of initial hospitalization

    Time frame: 6 weeks

    total medical cost of initial hospitalization

  5. duration of initial hospitalization

    Time frame: 6 weeks

    duration of initial hospitalization

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 27, 2016
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.