MedDataX Logo

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

NCT ID: NCT02946528

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2021-11-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End-Stage Renal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

urgent-start peritoneal dialysis

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

Group Type EXPERIMENTAL

urgent-start peritoneal dialysis catheter

Intervention Type DEVICE

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

urgent-start hemodialysis

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

Group Type ACTIVE_COMPARATOR

central venous catheter

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

urgent-start peritoneal dialysis catheter

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

Intervention Type DEVICE

central venous catheter

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ruijin Hospital

OTHER

Sponsor Role collaborator

Xin Hua Hospital

OTHER

Sponsor Role collaborator

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Shanghai Tong Ren Hospital

OTHER

Sponsor Role collaborator

Shanghai Jiading District Central Hospital

OTHER

Sponsor Role collaborator

Shanghai Songjiang District Central Hospital

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Shanghai Punan Hospital

UNKNOWN

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhaohui Ni, Doctor

Role: STUDY_CHAIR

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Gengru Jiang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Niansong Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University

Zhiyong Guo, Doctor

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Xiaonong Chen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Feng Ding, Doctor

Role: PRINCIPAL_INVESTIGATOR

No.9 People Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Weijie Yuan, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital affiliated to Shanghai Jiao Tong University

Yueyi Deng, Doctor

Role: PRINCIPAL_INVESTIGATOR

Long Hua Hospital Shanghai University of Traditional Chinese Medicine

Xiaoxia Wang

Role: PRINCIPAL_INVESTIGATOR

Tong Ren hospital Shanghai Jiao Tong university school of medicine

Ying Li

Role: PRINCIPAL_INVESTIGATOR

Jiading district central hospital of Shanghai

Xiujuan Zang

Role: PRINCIPAL_INVESTIGATOR

hanghai Songjiang District Central Hospital

Guoqing Wu

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

RenJi Hospital

Shanghai, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22019332 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26374834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27178678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16825263 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24353321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21622993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18424817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26702001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24525597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24246221 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33501650 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33320346 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RJ20161021USPD

Identifier Type: -

Identifier Source: org_study_id