Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
200

Summary

Conditions
End Stage Renal Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

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 di...

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.

Tracking Information

NCT #
NCT02946528
Collaborators
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Ruijin Hospital
  • Xin Hua Hospital
  • 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
Investigators
Study Chair: Zhaohui Ni, Doctor Renji Hospital, School of Medicine, Shanghai Jiao Tong University Principal Investigator: Gengru Jiang, Doctor Xin Hua Hospital Affiliated to 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 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