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

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ClinicalTrials.gov Identifier: NCT04088526
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Changlin Mei, 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease on Dialysis Combination Product: intervention group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
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 : January 1, 2016
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

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.




Primary Outcome Measures :
  1. mortality [ Time Frame: one year ]
    mortality and death cause


Secondary Outcome Measures :
  1. hospitalization [ Time Frame: one year ]
    hospitalization rate and cause



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088526


Contacts
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Contact: Xiaojing Tang, Ph.D. +8613816829057 samitang@163.com

Locations
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China, Shanghai
Department of Nephrology, Shanghai Changzheng Hospital Recruiting
Shanghai, Shanghai, China, 200003
Contact: Changlin Mei, MD    +862181885391    chlmei1954@126.com   
Contact: Xiaojing Tang, PHD    +8613816829057    samitang@163.com   
Principal Investigator: Changlin Mei, MD         
Sub-Investigator: Shengqiang Yu, PHD         
Sub-Investigator: Xiaojing Tang, PHD         
Sub-Investigator: Daoliang Xu, MD         
Sub-Investigator: Changhua Liu, MD         
Sub-Investigator: Can He, MD         
Sponsors and Collaborators
Shanghai Changzheng Hospital
Investigators
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Principal Investigator: Changlin Mei, M.D. Shanghai Changzheng Hospital

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Responsible Party: Changlin Mei, Director of Kidney Institution of PLA, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT04088526     History of Changes
Other Study ID Numbers: CZKIPLA-ESRD-001
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency