End-stage Renal Disease
Conditions
Keywords
Hemodialysis, residual renal function, Remote ischemic conditioning
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.
Interventions
DEVICERemote 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.
DEVICESham 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.
Sponsors
Yuanjun Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Only Research Assistant will be unblinded. Participant, clinical team, PI, etc. will all be blinded to the randomization group.
Intervention model description
randomized controlled pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| time to anuria | 10 months | defined as ≤100 ml/d or ≤200 ml of urine volume in the short interdialytic period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein (CRP) | 10 months | Taking a blood test to evaluation CRP |
| TFF3 | 10 months | Taking a urine test to evaluation TFF3 |
| KIM-1 | 10 months | Taking a urine test to evaluation KIM-1 |
| IP-10 | 10 months | Taking a urine test to evaluation IP-10 |
| Interleukin-6 | 10 months | Taking a blood test to evaluation Interleukin-6 |
| serum creatinine | 10 months | Taking a blood test to evaluation creatinine |
| serum urea nitrogen | 10 months | Taking a blood test to evaluation urea nitrogen |
Other
| Measure | Time frame | Description |
|---|---|---|
| hemoglobin | 10 months | Collect data at baseline and during each follow-up visit. |
| diastolic pressure | 10 months | Collect data at baseline and during each follow-up visit. |
| systolic pressure | 10 months | Collect data at baseline and during each follow-up visit |
Countries
China
Outcome results
None listed