Back to resultsSurvey and Reduction of Mortality in Peridialysis Uremic Patients Via Intervention of Risk Factors (SURVIVOR)
Primary Purpose
End Stage Renal Disease on Dialysis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intervention group
Sponsored by
About this trial
This is an interventional screening trial for End Stage Renal Disease on Dialysis
Eligibility 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
Sites / Locations
- Department of Nephrology, Shanghai Changzheng HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention group
Arm Description
Through the effective intervention of risk factors for death in patients with dialysis, the effect of mortality of peri-dialysis patients was observed.
Outcomes
Primary Outcome Measures
mortality
mortality and death cause
Secondary Outcome Measures
hospitalization
hospitalization rate and cause
Full Information
NCT ID
NCT04088526
First Posted
September 11, 2019
Last Updated
September 18, 2019
Sponsor
Shanghai Changzheng Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04088526
Brief Title
Survey and Reduction of Mortality in Peridialysis Uremic Patients Via Intervention of Risk Factors
Acronym
SURVIVOR
Official Title
Survey and Reduction of Mortality in Uremic Patients During Peridialysis Period Via Intervention of Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Changzheng Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Dialysis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
Through the effective intervention of risk factors for death in patients with dialysis, the effect of mortality of peri-dialysis patients was observed.
Intervention Type
Combination Product
Intervention Name(s)
intervention group
Intervention Description
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 Measure Information:
Title
mortality
Description
mortality and death cause
Time Frame
one year
Secondary Outcome Measure Information:
Title
hospitalization
Description
hospitalization rate and cause
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojing Tang, Ph.D.
Phone
+8613816829057
Email
samitang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changlin Mei, M.D.
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology, Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changlin Mei, MD
Phone
+862181885391
Email
chlmei1954@126.com
First Name & Middle Initial & Last Name & Degree
Xiaojing Tang, PHD
Phone
+8613816829057
Email
samitang@163.com
First Name & Middle Initial & Last Name & Degree
Changlin Mei, MD
First Name & Middle Initial & Last Name & Degree
Shengqiang Yu, PHD
First Name & Middle Initial & Last Name & Degree
Xiaojing Tang, PHD
First Name & Middle Initial & Last Name & Degree
Daoliang Xu, MD
First Name & Middle Initial & Last Name & Degree
Changhua Liu, MD
First Name & Middle Initial & Last Name & Degree
Can He, MD
12. IPD Sharing Statement
Learn more about this trial
Survey and Reduction of Mortality in Peridialysis Uremic Patients Via Intervention of Risk Factors
We'll reach out to this number within 24 hrs