Clinical trial NCT02946528: 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
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Xin Hua Hospital
name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Changhai Hospital
name: Shanghai University of Traditional Chinese Medicine
name: Shanghai Tong Ren Hospital
name: Shanghai Jiading District Central Hospital
name: Shanghai Songjiang District Central Hospital
name: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
name: Shanghai Punan Hospital
First posted: 2016-10-27
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the incidence of dialysis-related complications
timeFrame: 12 months
Secondary outcomes:
measure: PD catheter technical survival rate
timeFrame: 12 months
measure: peritonitis-free survival rates
timeFrame: 12 months
measure: patient survival rate
timeFrame: 12 months
measure: total medical cost of initial hospitalization
timeFrame: 6 weeks
measure: duration of initial hospitalization
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJi Hospital
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Zhaohui Ni, Doctor
role: STUDY_CHAIR
affiliation: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Gengru Jiang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Niansong Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Changhai Hospital
name: Zhiyong Guo, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Xiaonong Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: No.9 People Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Feng Ding, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai General Hospital affiliated to Shanghai Jiao Tong University
name: Weijie Yuan, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Long Hua Hospital Shanghai University of Traditional Chinese Medicine
name: Yueyi Deng, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tong Ren hospital Shanghai Jiao Tong university school of medicine
name: Xiaoxia Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiading district central hospital of Shanghai
name: Ying Li
role: PRINCIPAL_INVESTIGATOR
affiliation: hanghai Songjiang District Central Hospital
name: Xiujuan Zang
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
name: Guoqing Wu
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.