Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory and cell survival pathways, and thus protect remote organs against future ischemic injury. We hypothesize that compared to sham treatment, RIPC will be associated with decreased post-operative acute kidney, myocardial, and lung injury.
In children undergoing cardiac surgery and cardiopulmonary bypass (CPB), our primary aims are to determine whether RPC is associated with: 1) decreased AKI and 2) decreased acute myocardial injury. Secondary aims include investigating the effects of RPC on post-procedure: 1)acute lung injury and 2) morbidity/mortality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
90
RIPC will be elicited in the operating room (OR) after anesthesia induction and before start of surgery. After placement of an arterial line, a tourniquet will be placed over a lower extremity. It will be inflated to 15 mmHg above systolic blood pressure for 5 minutes, and then deflated for 5 minutes. This cycle of inflation-deflation will be repeated another 3 times before surgery.
In OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes.
Seattle Children's Hospital
Seattle, Washington, United States
Incidence of acute kidney injury (AKI)
Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3.
Time frame: 72 hours
Incidence of acute myocardial injury
Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative.
Time frame: 48 hours
Incidence of acute lung injury
Days on mechanical ventilation, readiness for extubation.
Time frame: 72 hours and duration of hospitalization
Hospitalization
Number of post-operative days in cardiac intensive care unit (CICU) and hospital.
Time frame: Duration of post-operative hospitalization
Mortality
Time frame: Duration of hospitalization, 30 days post-op, and at last follow-up
Biomarkers for AKI
Serum and urine will be collected for biomarker discovery.
Time frame: 72 hours
Inflammation
Cytokines will be measured at baseline until 72 hours post-operative.
Time frame: 72 hours
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