End-stage Renal Disease Clinical Trial
— RIC-HDOfficial title:
The Protective Effect of Remote Ischemic Conditioning on Residual Renal Function in Hemodialysis Patients: A Multicenter, Randomized, Double-blind, Sham-controlled Trial.
Verified date | February 2024 |
Source | Chinese PLA General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hemodialysis (HD) is the main renal replacement therapy for patients with end-stage renal disease. However, factors such as hemodynamic instability can lead to gradual loss of residual renal function (RRF) in HD patients. The loss of RRF not only affects the adequacy of dialysis and complications control but also impacts the patients' quality of life and survival. Unfortunately, there are currently no effective methods to protect RRF. The purpose of this study is to validate the protective effect of remote ischemic conditioning (RIC) on RRF in HD patients. This will provide evidence for the application of RIC in protecting RRF in HD patients.
Status | Enrolling by invitation |
Enrollment | 60 |
Est. completion date | January 19, 2026 |
Est. primary completion date | January 19, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years; - First-time initiators of hemodialysis treatment for end-stage renal disease patients; - Urine output > 500ml/day or GFR > 3ml/min/1.72m2; - Hemodialysis access as a central venous catheter. - Signed and dated informed consented is obtained; Exclusion Criteria: - Active infection; - Infectious disease; - Expected dialysis duration < 6 months; - Presence of vascular access dysfunction (blood flow rate < 180ml/min); - Patients who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper extremities, venous thrombosis in the acute or subacute stage of upper extremities; - Pregnancy or lactation women; - Patients who are participating in other clinical studies, or who have participated in other clinical studies within 3 months prior to enrollment; - Unwillingness to be followed up or poor adherence to treatment; - Other circumstances that the investigator considers unsuitable for enrolment. |
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Yuanjun Yang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | hemoglobin | Collect data at baseline and during each follow-up visit. | 10 months | |
Other | systolic pressure | Collect data at baseline and during each follow-up visit | 10 months | |
Other | diastolic pressure | Collect data at baseline and during each follow-up visit. | 10 months | |
Primary | time to anuria | defined as =100 ml/d or =200 ml of urine volume in the short interdialytic period | 10 months | |
Primary | residual renal function (RRF) | The RRF was calculated from an interdialytic urine collection and pre- and post-dialysate blood samples as the mean of the urea and creatinine clearances adjusted for body surface area using a "GFR calculator" | 10 months | |
Primary | Change in the renal cerebral oxygen saturation | Measured by Near Infrared Spectroscopy | 10 months | |
Secondary | serum creatinine | Taking a blood test to evaluation creatinine | 10 months | |
Secondary | serum urea nitrogen | Taking a blood test to evaluation urea nitrogen | 10 months | |
Secondary | C-reactive protein (CRP) | Taking a blood test to evaluation CRP | 10 months | |
Secondary | Interleukin-6 | Taking a blood test to evaluation Interleukin-6 | 10 months | |
Secondary | TFF3 | Taking a urine test to evaluation TFF3 | 10 months | |
Secondary | KIM-1 | Taking a urine test to evaluation KIM-1 | 10 months | |
Secondary | IP-10 | Taking a urine test to evaluation IP-10 | 10 months |
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