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

NCT02946528 | Completed DMC

• 1 other identifier: RJ20161021USPD
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

End-Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• PD catheter technical survival rate

  12 months

• peritonitis-free survival rates

  12 months

• patient survival rate

  12 months

• total medical cost of initial hospitalization

  6 weeks

• duration of initial hospitalization

  6 weeks

Study Arms (2)

urgent-start peritoneal dialysis

EXPERIMENTAL

All patients in urgent-start peritoneal dialysis arm initiate peritoneal dialysis as urgent-start dialysis modality.

Device: urgent-start peritoneal dialysis catheter

urgent-start hemodialysis

ACTIVE COMPARATOR

All patients in urgent-start hemodialysis arm initiate hemodialysis as urgent-start dialysis modality.

Device: central venous catheter

Interventions

urgent-start peritoneal dialysis catheter DEVICE

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

urgent-start peritoneal dialysis

central venous catheter DEVICE

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

urgent-start hemodialysis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

RenJi Hospital

Shanghai, China

Location

Related Publications (12)

• Ghaffari A. Urgent-start peritoneal dialysis: a quality improvement report. Am J Kidney Dis. 2012 Mar;59(3):400-8. doi: 10.1053/j.ajkd.2011.08.034. Epub 2011 Oct 22.

  PMID: 22019332 BACKGROUND

• Alkatheeri AM, Blake PG, Gray D, Jain AK. Success of Urgent-Start Peritoneal Dialysis in a Large Canadian Renal Program. Perit Dial Int. 2016 Mar-Apr;36(2):171-6. doi: 10.3747/pdi.2014.00148. Epub 2015 Sep 15.

  PMID: 26374834 BACKGROUND

• Wong LP, Li NC, Kansal S, Lacson E Jr, Maddux F, Kessler J, Curd S, Lester K, Herman M, Pulliam J. Urgent Peritoneal Dialysis Starts for ESRD: Initial Multicenter Experiences in the United States. Am J Kidney Dis. 2016 Sep;68(3):500-2. doi: 10.1053/j.ajkd.2016.03.426. Epub 2016 May 11. No abstract available.

  PMID: 27178678 BACKGROUND

• Povlsen JV, Ivarsen P. How to start the late referred ESRD patient urgently on chronic APD. Nephrol Dial Transplant. 2006 Jul;21 Suppl 2:ii56-9. doi: 10.1093/ndt/gfl192.

  PMID: 16825263 BACKGROUND

• Ivarsen P, Povlsen JV. Can peritoneal dialysis be applied for unplanned initiation of chronic dialysis? Nephrol Dial Transplant. 2014 Dec;29(12):2201-6. doi: 10.1093/ndt/gft487. Epub 2013 Dec 17.

  PMID: 24353321 BACKGROUND

• Koch M, Kohnle M, Trapp R, Haastert B, Rump LC, Aker S. Comparable outcome of acute unplanned peritoneal dialysis and haemodialysis. Nephrol Dial Transplant. 2012 Jan;27(1):375-80. doi: 10.1093/ndt/gfr262. Epub 2011 May 28.

  PMID: 21622993 BACKGROUND

• Lobbedez T, Lecouf A, Ficheux M, Henri P, Hurault de Ligny B, Ryckelynck JP. Is rapid initiation of peritoneal dialysis feasible in unplanned dialysis patients? A single-centre experience. Nephrol Dial Transplant. 2008 Oct;23(10):3290-4. doi: 10.1093/ndt/gfn213. Epub 2008 Apr 19.

  PMID: 18424817 BACKGROUND

• Povlsen JV, Sorensen AB, Ivarsen P. Unplanned Start on Peritoneal Dialysis Right after PD Catheter Implantation for Older People with End-Stage Renal Disease. Perit Dial Int. 2015 Nov;35(6):622-4. doi: 10.3747/pdi.2014.00347.

  PMID: 26702001 BACKGROUND

• Liu Y, Zhang L, Lin A, Ni Z, Qian J, Fang W. Impact of break-in period on the short-term outcomes of patients started on peritoneal dialysis. Perit Dial Int. 2014 Jan-Feb;34(1):49-56. doi: 10.3747/pdi.2012.00293.

  PMID: 24525597 BACKGROUND

• Arramreddy R, Zheng S, Saxena AB, Liebman SE, Wong L. Urgent-start peritoneal dialysis: a chance for a new beginning. Am J Kidney Dis. 2014 Mar;63(3):390-5. doi: 10.1053/j.ajkd.2013.09.018. Epub 2013 Nov 15.

  PMID: 24246221 BACKGROUND

• Htay H, Johnson DW, Craig JC, Teixeira-Pinto A, Hawley CM, Cho Y. Urgent-start peritoneal dialysis versus haemodialysis for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jan 27;1(1):CD012899. doi: 10.1002/14651858.CD012899.pub2.

  PMID: 33501650 DERIVED

• Htay H, Johnson DW, Craig JC, Teixeira-Pinto A, Hawley CM, Cho Y. Urgent-start peritoneal dialysis versus conventional-start peritoneal dialysis for people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 15;12(12):CD012913. doi: 10.1002/14651858.CD012913.pub2.

  PMID: 33320346 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Central Venous Catheters

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

Intervention Hierarchy (Ancestors)

Vascular Access Devices; Catheters; Equipment and Supplies

Study Officials

• Zhaohui Ni, Doctor

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 27, 2016
• Study Start: February 26, 2019
• Primary Completion: November 17, 2021
• Study Completion: November 17, 2021
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)