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

Sponsor
Shanghai Changzheng Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04088526
Collaborator
(none)
2,500
1
1
72
34.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: intervention group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Survey and Reduction of Mortality in Uremic Patients During Peridialysis Period Via Intervention of Risk Factors
Actual Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. mortality [one year]

    mortality and death cause

Secondary Outcome Measures

  1. hospitalization [one year]

    hospitalization rate and cause

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nephrology, Shanghai Changzheng Hospital Shanghai Shanghai China 200003

Sponsors and Collaborators

  • Shanghai Changzheng Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Changlin Mei, Director of Kidney Institution of PLA, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:
NCT04088526
Other Study ID Numbers:
  • CZKIPLA-ESRD-001
First Posted:
Sep 13, 2019
Last Update Posted:
Sep 20, 2019
Last Verified:
Sep 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2019