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

NCT06275152 | Enrolling By Invitation

• 1 other identifier: HDRIC-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease

Keywords

Hemodialysis; residual renal function; Remote ischemic conditioning

Outcome Measures

Primary Outcomes (3)

• 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

• Change in the renal cerebral oxygen saturation

  Measured by Near Infrared Spectroscopy

  10 months

Secondary Outcomes (7)

• serum creatinine

  10 months

• serum urea nitrogen

  10 months

• C-reactive protein (CRP)

  10 months

• Interleukin-6

  10 months

• TFF3

  10 months

Other Outcomes (3)

• hemoglobin

  10 months

• systolic pressure

  10 months

• diastolic pressure

  10 months

Study Arms (2)

RIC group

EXPERIMENTAL

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

Sham Remote Ischemic Conditioning

SHAM COMPARATOR

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

Interventions

Remote ischemic conditioning DEVICE

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.

RIC group

Sham Remote Ischemic Conditioning DEVICE

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.

Sham Remote Ischemic Conditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuanjun Yang: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guangyan Cai

  Chinese PLA General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only Research Assistant will be unblinded. Participant, clinical team, PI, etc. will all be blinded to the randomization group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: randomized controlled pilot study

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 23, 2024
• Study Start: February 20, 2024
• Primary Completion: January 19, 2026
• Study Completion: January 19, 2026
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

CN (1)