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

Study Overview
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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.

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

Conditions
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End Stage Renal Disease on Dialysis

Intervention / Treatment
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* Combination Product: intervention group


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>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<br>* 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.<br>|

What is the study measuring?
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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 |