End-Stage Renal Disease
Conditions
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.
Interventions
DEVICEurgent-start peritoneal dialysis catheter
Patients initiated peritoneal dialysis as urgent-start dialysis modality with a peritoneal dialysis catheter.
DEVICEcentral venous catheter
Patients initiated hemodialysis as urgent-start dialysis modality with a central venous catheter.
Sponsors
Ruijin Hospital
Xin Hua Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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
Shanghai Punan Hospital
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of dialysis-related complications | 12 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PD catheter technical survival rate | 12 months | PD catheter technical survival rate |
| peritonitis-free survival rates | 12 months | peritonitis-free survival rates |
| patient survival rate | 12 months | patient survival rate |
| total medical cost of initial hospitalization | 6 weeks | total medical cost of initial hospitalization |
| duration of initial hospitalization | 6 weeks | duration of initial hospitalization |
Countries
China
Outcome results
None listed