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

End-stage Renal Disease Clinical Trial

— RIC-HD  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06275152
• Other study ID #: HDRIC-01
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

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