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

End-Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946528
• Other study ID #: RJ20161021USPD
• Status: Completed
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: November 17, 2021

Study information

• Verified date: December 2023
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: November 17, 2021
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• urgent-start peritoneal dialysis catheter
Patients initiated peritoneal dialysis as urgent-start dialysis modality with a peritoneal dialysis catheter.
• central venous catheter
Patients initiated hemodialysis as urgent-start dialysis modality with a central venous catheter.

Locations

Country	Name	City	State
China	RenJi Hospital	Shanghai

Sponsors (11)

Lead Sponsor	Collaborator
RenJi Hospital	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

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PD catheter technical survival rate	PD catheter technical survival rate	12 months
Secondary	peritonitis-free survival rates	peritonitis-free survival rates	12 months
Secondary	patient survival rate	patient survival rate	12 months
Secondary	total medical cost of initial hospitalization	total medical cost of initial hospitalization	6 weeks
Secondary	duration of initial hospitalization	duration of initial hospitalization	6 weeks