Renal Effects of RIPC in Patients After Total Arch Replacement

Study Overview
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Brief Summary
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The purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.

Detailed Description
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Acute kidney injury (AKI) is a well-recognized complication after cardio-thoracic surgeries and is associated with increased morbidity and mortality. Total arch replacement is reported with a relatively high incidence of post-operative AKI. In addition, few effective preventive or therapeutic interventions for AKI have been identified. A number of studies have now addressed renal protection as a primary outcome following RIPC. Because the mechanism of I/R injury are similar to those proposed for AKI after CPB, the purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.

Official Title
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Renal Effects of Remote Ischemic Preconditioning in Patients After Total Arch Replacement

Conditions
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Dialysis, Acute Kidney Injury

Intervention / Treatment
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* Other: remote ischemic preconditioning
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scheduled for total arch replacement written informed consent Exclusion Criteria: pre-existing AKI peripheral vascular disease affecting the upper limbs hybrid total arch replacement the history of kidney transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC intervention<br>Remote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation) | Other: remote ischemic preconditioning<br>* Remote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation)<br>|
| Sham Comparator: Control<br>Four cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated. | Other: Control<br>* Four cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AKI within the 7 days after the surgery | AKI defined by KDIGO criteria | Within 7 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe AKI (stage 2 and stage 3) | severity defined by KDIGO criteria | Within 7 days after the surgery | 
| Renal replacement therapy | the requirement for RRT during index hospital stay | Within 30 days after the surgery | 
| Mechanical ventilation duration | duration of mechanical ventilation in the intensive care unit | Within 30 days after the surgery | 
| Length of intensive care unit stay | length of stay on the intensive care unit | Within 30 days after the surgery | 
| In-hospital death | in-hospital all-cause death | Within 30 days after the surgery | 
| Stroke | new onset stroke during index hospital stay | Within 30 days after the surgery | 
| Paraplegia | impairment in motor or sensory function of the lower extremities during index hospital stay | Within 30 days after the surgery |