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

NCT ID: NCT04088526

Last Updated: 2019-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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End Stage Renal Disease on Dialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

intervention group

Intervention Type 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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Changzheng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Changlin Mei

Director of Kidney Institution of PLA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Changlin Mei, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospital

Locations

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Department of Nephrology, Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaojing Tang, Ph.D.

Role: CONTACT

+8613816829057

Facility Contacts

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Changlin Mei, MD

Role: primary

+862181885391

Xiaojing Tang, PHD

Role: backup

+8613816829057

Other Identifiers

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CZKIPLA-ESRD-001

Identifier Type: -

Identifier Source: org_study_id

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