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

NCT04088526 | Unknown

• 1 other identifier: CZKIPLA-ESRD-001
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (1)

• mortality

  mortality and death cause

  one year

Secondary Outcomes (1)

• hospitalization

  one year

Study Arms (1)

intervention group

EXPERIMENTAL

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

Interventions

intervention group COMBINATION_PRODUCT

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.

intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Department of Nephrology, Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Study Officials

• Changlin Mei, M.D.

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojing Tang, Ph.D.

CONTACT

+8613816829057; samitang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Kidney Institution of PLA

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 13, 2019
• Study Start: January 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

CN (1)