Acute Kidney Injury, Dialysis
Conditions
Brief summary
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
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.
Interventions
OTHERremote ischemic preconditioning
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)
OTHERControl
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.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AKI within the 7 days after the surgery | Within 7 days after the surgery | AKI defined by KDIGO criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal replacement therapy | Within 30 days after the surgery | the requirement for RRT during index hospital stay |
| Mechanical ventilation duration | Within 30 days after the surgery | duration of mechanical ventilation in the intensive care unit |
| Length of intensive care unit stay | Within 30 days after the surgery | length of stay on the intensive care unit |
| Incidence of severe AKI (stage 2 and stage 3) | Within 7 days after the surgery | severity defined by KDIGO criteria |
| Stroke | Within 30 days after the surgery | new onset stroke during index hospital stay |
| Paraplegia | Within 30 days after the surgery | impairment in motor or sensory function of the lower extremities during index hospital stay |
| In-hospital death | Within 30 days after the surgery | in-hospital all-cause death |
Countries
China
Outcome results
None listed