Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| Xin Hua Hospital of Zhejiang Province | OTHER |
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital | OTHER |
| Changhai Hospital |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| urgent-start peritoneal dialysis | Experimental | All patients in urgent-start peritoneal dialysis arm initiate peritoneal dialysis as urgent-start dialysis modality. |
|
| urgent-start hemodialysis | Active Comparator | All patients in urgent-start hemodialysis arm initiate hemodialysis as urgent-start dialysis modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| urgent-start peritoneal dialysis catheter | Device | Patients initiated peritoneal dialysis as urgent-start dialysis modality with a peritoneal dialysis catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PD catheter technical survival rate | PD catheter technical survival rate | 12 months |
| peritonitis-free survival rates | peritonitis-free survival rates |
Not provided
Inclusion criteria
Patients will be eligible to be included in the study only if all of the following criteria are applicable:
Exclusion criteria:
Patients will be excluded from the study if any of the following criteria are applicable:
(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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhaohui Ni, Doctor | Renji Hospital, School of Medicine, Shanghai Jiao Tong University. | Study Chair |
| Gengru Jiang, Doctor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Niansong Wang, Doctor | The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Zhiyong Guo, Doctor | Changhai Hospital | Principal Investigator |
| Xiaonong Chen, Doctor | Ruijin Hospital | Principal Investigator |
| Feng Ding, Doctor | No.9 People Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Weijie Yuan, Doctor | Shanghai General Hospital affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Yueyi Deng, Doctor | Long Hua Hospital Shanghai University of Traditional Chinese Medicine | Principal Investigator |
| Xiaoxia Wang | Tong Ren hospital Shanghai Jiao Tong university school of medicine |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RenJi Hospital | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22019332 | Background | 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. | |
| 26374834 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D062905 | Central Venous Catheters |
| ID | Term |
|---|---|
| D062666 | Vascular Access Devices |
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
Not provided
Not provided
| OTHER |
| Shanghai University of Traditional Chinese Medicine | OTHER |
| Shanghai Tong Ren Hospital | OTHER |
| Shanghai Jiading District Central Hospital | OTHER |
| Shanghai Songjiang District Central Hospital | UNKNOWN |
| The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine | OTHER |
| Shanghai Punan Hospital | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
| central venous catheter | Device | Patients initiated hemodialysis as urgent-start dialysis modality with a central venous catheter. |
|
| 12 months |
| patient survival rate | patient survival rate | 12 months |
| total medical cost of initial hospitalization | total medical cost of initial hospitalization | 6 weeks |
| duration of initial hospitalization | duration of initial hospitalization | 6 weeks |
| Principal Investigator |
| Ying Li | Jiading district central hospital of Shanghai | Principal Investigator |
| Xiujuan Zang | hanghai Songjiang District Central Hospital | Principal Investigator |
| Guoqing Wu | The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine | Principal Investigator |
| 27178678 | Background | 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. |
| 16825263 | Background | 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. |
| 24353321 | Background | 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. |
| 21622993 | Background | 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. |
| 18424817 | Background | 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. |
| 26702001 | Background | 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. |
| 24525597 | Background | 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. |
| 24246221 | Background | 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. |
| 33501650 | Derived | 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. |
| 33320346 | Derived | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |