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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06275152
Other study ID # HDRIC-01
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 20, 2024
Est. completion date January 19, 2026

Study information

Verified date February 2024
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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. Remote ischemic conditioning (RIC) is a simple, safe, non-invasive, and non-pharmacological intervention. It induces the remote organs to develop an anti-ischemic injury capacity through repeated and brief ischemic stimuli on limbs, thereby reducing ischemic damage. RIC is a clinically feasible method that is easy to implement and promote. It has been widely used in the treatment and research of cardiovascular and cerebrovascular diseases, as well as in the prevention of acute kidney injury related to thoracoabdominal surgery and contrast agents. Studies have also found that RIC significantly reduces myocardial ischemic injury in HD patients. Theoretically, RIC can also be used to protect the RRF in HD patients. This study aims to validate the protective effect of RIC on RRF in HD patients. This will provide evidence for the application of RIC in protecting RRF in HD patients.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Remote ischemic conditioning
RIC is a non-invasive therapy that performed by an electric auto-control device with cuff placed on arm. RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
Sham Remote Ischemic Conditioning
The sham-RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs.

Locations

Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Yuanjun Yang

Country where clinical trial is conducted

China, 

Outcome

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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