Survey and Reduction of Mortality in Peridialysis Uremic Patients Via Intervention of Risk Factors (SURVIVOR)

Survey and Reduction of Mortality in Uremic Patients During Peridialysis Period Via Intervention of Risk Factors

In patients with non-dialysis-dependent end stage kidney disease (ESKD) the common transition of care to renal replacement therapy is dialysis. Each year over 70 000 Chinese transition from non-dialysis-dependent ESKD to dialysis. Whereas dialysis therapy is intended to be life-sustaining, ESKD patients have a 10-fold or higher risk of death compared with the general population. Mortality rates are even higher upon transition and in the first year, especially in the first 3 to 6 months following the transition to dialysis, yet it remains unknown which is the contributing cause of this high death rate. Hence, there is an urgent need to examine the emerging field of Transition of Care in ESKD. We suggest the term "peridialysis period" for this transition period for ESKD patients, so that the transition of care from non-dialysis-dependent ESKD to dialysis ESKD can be more pragmatically defined and studied. In the current study, we will investigate the mortality and its risk factors of ESKD patients during peridialysis period, and improve the survival rate and quality of life of peridialysis ESKD patients by intervening the risk factors.

Study Overview

• Status: Unknown
• Conditions: End Stage Renal Disease on Dialysis
• Intervention / Treatment: Combination product: intervention group

• Study Type: Interventional
• Enrollment (Anticipated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaojing Tang, Ph.D.; Phone Number: +8613816829057; Email: samitang@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Recruiting
      • Department of Nephrology, Shanghai Changzheng Hospital
      • Contact: Xiaojing Tang, PHD; Phone Number: +8613816829057; Email: samitang@163.com
      • Sub-Investigator: Xiaojing Tang, PHD
      • Sub-Investigator: Daoliang Xu, MD
      • Sub-Investigator: Changhua Liu, MD
      • Sub-Investigator: Can He, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who have been diagnosed with end stage kidney disease (eGFR<15ml/min/1.73m2) or newly started dialysis with 3 months at all hospitals in Yangzhou, China since January 1, 2016

Exclusion Criteria:

• Patients who have had a history of dialysis and have been transferred to Yangzhou during this period;
• patients who are transferred to a dialysis area outside Yangzhou City
• Patients who give up dialysis treatment
• patient whose renal function recover and stop dialysis treatment;
• Patient who receive kidney transplantation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; Through the effective intervention of risk factors for death in patients with dialysis, the effect of mortality of peri-dialysis patients was observed.	Combination product: intervention group; Through effective intervention combined with drugs and dietary guidance within 3 to 6 months, all the observation markers including blood pressure and laboratory results will reach the target target value.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	mortality and death cause	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospitalization	hospitalization rate and cause	one year

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital
• Investigators: Principal Investigator: Changlin Mei, M.D., Shanghai Changzheng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: CZKIPLA-ESRD-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No