Clinical trial NCT06275152: The Protective Effect of Remote Ischemic Conditioning on Residual Renal Function in Hemodialysis Patients (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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: End-stage Renal Disease
Keywords: Hemodialysis
residual renal function
Remote ischemic conditioning
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled pilot study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: time to anuria
timeFrame: 10 months
measure: residual renal function (RRF)
timeFrame: 10 months
measure: Change in the renal cerebral oxygen saturation
timeFrame: 10 months
Secondary outcomes:
measure: serum creatinine
timeFrame: 10 months
measure: serum urea nitrogen
timeFrame: 10 months
measure: C-reactive protein (CRP)
timeFrame: 10 months
measure: Interleukin-6
timeFrame: 10 months
measure: TFF3
timeFrame: 10 months
measure: KIM-1
timeFrame: 10 months
measure: IP-10
timeFrame: 10 months
Other outcomes:
measure: hemoglobin
timeFrame: 10 months
measure: systolic pressure
timeFrame: 10 months
measure: diastolic pressure
timeFrame: 10 months
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Guangyan Cai
role: STUDY_DIRECTOR
References: