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

The Protective Effect of Remote Ischemic Conditioning on Residual Renal Function in Hemodialysis Patients: A Multicenter, Randomized, Double-blind, Sham-controlled Trial.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: End-stage Renal Disease
• Intervention / Treatment: Device: Remote ischemic conditioning; Device: Sham Remote Ischemic Conditioning

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIC group; 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.	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 Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the renal cerebral oxygen saturation	Measured by Near Infrared Spectroscopy	10 months
time to anuria	defined as ≤100 ml/d or ≤200 ml of urine volume in the short interdialytic period	10 months
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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemoglobin	Collect data at baseline and during each follow-up visit.	10 months
diastolic pressure	Collect data at baseline and during each follow-up visit.	10 months
systolic pressure	Collect data at baseline and during each follow-up visit	10 months

Collaborators and Investigators

• Sponsor: Yuanjun Yang
• Investigators: Study Director: Guangyan Cai, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2024
• Primary Completion (Estimated): January 19, 2026
• Study Completion (Estimated): January 19, 2026

Study Registration Dates

• First Submitted: February 17, 2024
• First Submitted That Met QC Criteria: February 17, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hemodialysis; Remote ischemic conditioning; residual renal function
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: HDRIC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No