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

Not Applicable

• Conditions: End Stage Renal Disease on Dialysis
• Interventions: Combination Product: intervention group

• Registration Number: NCT04088526
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2019-09
• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-13
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention group	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.

Primary Outcome Measures

Name	Time	Method
mortality	one year	mortality and death cause

Secondary Outcome Measures

Name	Time	Method
hospitalization	one year	hospitalization rate and cause

Trial Locations

Locations (1)

Department of Nephrology, Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China