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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| hemoglobin | Collect data at baseline and during each follow-up visit. | 10 months |
| systolic pressure | Collect data at baseline and during each follow-up visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guangyan Cai | Chinese PLA General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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randomized controlled pilot study
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Only Research Assistant will be unblinded. Participant, clinical team, PI, etc. will all be blinded to the randomization 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. |
|
| 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 |
| 10 months |
| diastolic pressure | Collect data at baseline and during each follow-up visit. | 10 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |