The Protective Effect of Remote Ischemic Conditioning on Residual Renal Function in Hemodialysis Patients (RIC-HD)

Not Applicable

• Conditions: End-stage Renal Disease
• Interventions: Device: Remote ischemic conditioning; Device: Sham Remote Ischemic Conditioning

• Registration Number: NCT06275152
• Lead Sponsor: Yuanjun Yang

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-17
• Study First Submitted QC: 2024-02-17
• Study Start: 2024-02-20
• Study First Posted: 2024-02-23
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2026-01-19
• Study Completion: 2026-01-19

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIC group	Remote ischemic conditioning	RIC interventions will be applied to the upper extremity for a total of 20 cumulative minutes of limb ischemia, at a pressure of 200 mmHg.
Sham Remote Ischemic Conditioning	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.

Primary Outcome Measures

Name	Time	Method
time to anuria	10 months	defined as ≤100 ml/d or ≤200 ml of urine volume in the short interdialytic period
residual renal function (RRF)	10 months	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"
Change in the renal cerebral oxygen saturation	10 months	Measured by Near Infrared Spectroscopy

Secondary Outcome Measures

Name	Time	Method
TFF3	10 months	Taking a urine test to evaluation TFF3
serum urea nitrogen	10 months	Taking a blood test to evaluation urea nitrogen
C-reactive protein (CRP)	10 months	Taking a blood test to evaluation CRP
Interleukin-6	10 months	Taking a blood test to evaluation Interleukin-6
KIM-1	10 months	Taking a urine test to evaluation KIM-1
IP-10	10 months	Taking a urine test to evaluation IP-10
serum creatinine	10 months	Taking a blood test to evaluation creatinine

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China