Status:
TERMINATED
The Study of Efficacy and Safety of Automated PD in Urgent Start Dialysis
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
First Hospital of China Medical University
Beijing Anzhen Hospital
Conditions:
ESRD
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a multi-center, controlled clinical trial study. The purpose of this study is to examine the efficacy and safety of automated peritoneal dialysis as compared with intermittent haemodialysis fo...
Detailed Description
Hemodialysis（HD） and peritoneal dialysis (PD) are both the main methods to treat with end-stage renal disease (ESRD) uremia patients. The first 3-month mortality and hospitalization rate of new dialys...
Eligibility Criteria
Inclusion
- CKD(chronic kidney disease)-5 stage patient whose eGFR（CKD-EPI（chronic kidney disease-epidemiology collaboration））\<15 ml/min/1.73m2,occured uremic symptoms or volume overload need of renal replacement therapy(RRT) within 14 days .
- Prolonged RRT access is not available.
- No dialysis treatment was given within 1 months.
- The vital signs are stable and tolerable in peritoneal dialysis catheterization or central venous catheterization.
- Able to understand the whole process of the trial, voluntarily participate in and sign informed consent.
Exclusion
- Maintenance RRT alraedy.
- Serious metabolic disorders ( hyperkalemia and acidosis) cause significant changes in electrocardiogram or other emergency indications to RRT within 24 hours.
- Hypertensive emergencies(diastolic blood pressure\>130mmHg)
- Severe respiratory, circulatory or hepatic failure requires instrumental support or vasoactive drugs to maintain vital signs.
- High catabolic state eg. severe inflammation or trauma
- Absolute contraindication of peritoneal dialysis such as recent abdominal surgery (\<1month), multiple abdominal surgeries.
- Absolute contraindication for hemodialysis such as hemodynamic instability (systolic blood pressure \<80mmHg).
- Pregnant.
- Expected to survive for less than 1 years.
- Plan for kidney transplantation within 3 months.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03754361
Start Date
January 1 2019
End Date
December 28 2022
Last Update
June 8 2025
Active Locations (5)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
3
Beijing Luhe Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 101149
4
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001