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

Primary Purpose

End-Stage Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
urgent-start peritoneal dialysis catheter
central venous catheter
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ESRD patients who need urgent-start dialysis(Urgent-start dialysis is defined as ESRD patients who required initiation of dialysis in 2 weeks without pre-established functional vascular access or a PD catheter.)
  • patients who signs a informed consent form

Exclusion Criteria:

  • patients with severe volume overload with pulmonary edema
  • patients with hyperkalemia (>6.5 mmol/L)
  • patients with uremia encephalopathy
  • patients with severe risk of bleeding or hemorrhagic disease
  • patients with severe hepatic failure
  • 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
  • patients with Intracranial hemorrhage or increased intracranial pressure
  • patients with uncorrectable shock
  • patients who cannot establish a vascular access
  • patients with malignancy
  • patients with mental disorder
  • patients with pregnancy or lactation
  • patients who are not suitable for inclusion in this study determined by reseachers

Sites / Locations

  • RenJi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

urgent-start peritoneal dialysis

urgent-start hemodialysis

Arm Description

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

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

Outcomes

Primary Outcome Measures

number of participants with dialysis-related complications
number of participants with dialysis-related complications including infectious complications(peritonitis and catheter-related infection) and noninfectious complications(thrombosis, bleeding, malposition and blockage)

Secondary Outcome Measures

Patient survival

Full Information

First Posted
October 24, 2016
Last Updated
May 20, 2021
Sponsor
RenJi Hospital
Collaborators
Ruijin Hospital, Xin Hua Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Changhai Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Tong Ren Hospital, Shanghai Jiading District Central Hospital, Shanghai Songjiang District Central Hospital, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02946528
Brief Title
Urgent-start Peritoneal Dialysis in ESRD Patients:A Multi-center Study
Official Title
Urgent-start Peritoneal Dialysis to Improve Treatment in ESRD Patients:A Multi-center Clinical Tial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
Collaborators
Ruijin Hospital, Xin Hua Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Changhai Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Tong Ren Hospital, Shanghai Jiading District Central Hospital, Shanghai Songjiang District Central Hospital, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
urgent-start peritoneal dialysis
Arm Type
Experimental
Arm Description
All patients in urgent-start peritoneal dialysis arm initiate peritoneal dialysis as urgent-start dialysis modality.
Arm Title
urgent-start hemodialysis
Arm Type
Active Comparator
Arm Description
All patients in urgent-start hemodialysis arm initiate hemodialysis as urgent-start dialysis modality.
Intervention Type
Device
Intervention Name(s)
urgent-start peritoneal dialysis catheter
Intervention Description
Patients initiated peritoneal dialysis as urgent-start dialysis modality with a peritoneal dialysis catheter.
Intervention Type
Device
Intervention Name(s)
central venous catheter
Intervention Description
Patients initiated hemodialysis as urgent-start dialysis modality with a central venous catheter.
Primary Outcome Measure Information:
Title
number of participants with dialysis-related complications
Description
number of participants with dialysis-related complications including infectious complications(peritonitis and catheter-related infection) and noninfectious complications(thrombosis, bleeding, malposition and blockage)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patient survival
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ESRD patients who need urgent-start dialysis(Urgent-start dialysis is defined as ESRD patients who required initiation of dialysis in 2 weeks without pre-established functional vascular access or a PD catheter.) patients who signs a informed consent form Exclusion Criteria: patients with severe volume overload with pulmonary edema patients with hyperkalemia (>6.5 mmol/L) patients with uremia encephalopathy patients with severe risk of bleeding or hemorrhagic disease patients with severe hepatic failure 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 patients with Intracranial hemorrhage or increased intracranial pressure patients with uncorrectable shock patients who cannot establish a vascular access patients with malignancy patients with mental disorder patients with pregnancy or lactation patients who are not suitable for inclusion in this study determined by reseachers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Ni, Doctor
Phone
+8613917735313
Email
profnizh@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shan Mou, Doctor
Phone
+8613918221242
Email
shan_mou@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Ni, Doctor
Organizational Affiliation
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gengru Jiang, Doctor
Organizational Affiliation
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niansong Wang, Doctor
Organizational Affiliation
The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhiyong Guo, Doctor
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaonong Chen, Doctor
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Feng Ding, Doctor
Organizational Affiliation
No.9 People Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weijie Yuan, Doctor
Organizational Affiliation
Shanghai General Hospital affiliated to Shanghai Jiao Tong University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yueyi Deng, Doctor
Organizational Affiliation
Long Hua Hospital Shanghai University of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaoxia Wang
Organizational Affiliation
Tong Ren hospital Shanghai Jiao Tong university school of medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ying Li
Organizational Affiliation
Jiading district central hospital of Shanghai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiujuan Zang
Organizational Affiliation
hanghai Songjiang District Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guoqing Wu
Organizational Affiliation
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
RenJi Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Ni, Dr
Phone
13917735313
Email
profnizh@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22019332
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.
Results Reference
background
PubMed Identifier
26374834
Citation
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.
Results Reference
background
PubMed Identifier
27178678
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.
Results Reference
background
PubMed Identifier
16825263
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.
Results Reference
background
PubMed Identifier
24353321
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.
Results Reference
background
PubMed Identifier
21622993
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.
Results Reference
background
PubMed Identifier
18424817
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.
Results Reference
background
PubMed Identifier
26702001
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.
Results Reference
background
PubMed Identifier
24525597
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.
Results Reference
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PubMed Identifier
24246221
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.
Results Reference
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PubMed Identifier
33501650
Citation
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.
Results Reference
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PubMed Identifier
33320346
Citation
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.
Results Reference
derived

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

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