Acute Kidney Injury, Acute Lung Injury, Cardiopulmonary Bypass, Congenital Heart Disease, Myocardial Injury
Conditions
Keywords
Pediatric, Cardiac, Surgery, Cardiopulmonary, Bypass, Myocardial, Kidney, Lung, Injury
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURERIPC
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.
PROCEDUREControl
In OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes.
Sponsors
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
Age birth to 18 years Cardiac surgery with planned cardiopulmonary bypass
Exclusion criteria
Any contraindication to compression of lower extremity/extremities Body weight \<2 kg Active infection going into surgery On renal replacement therapy (RRT) or mechanical circulatory support going into surgery On inotropic support going into surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute kidney injury (AKI) | 72 hours | Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3. |
| Incidence of acute myocardial injury | 48 hours | Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Duration of hospitalization, 30 days post-op, and at last follow-up | — |
| Incidence of acute lung injury | 72 hours and duration of hospitalization | Days on mechanical ventilation, readiness for extubation. |
| Inflammation | 72 hours | Cytokines will be measured at baseline until 72 hours post-operative. |
| Biomarkers for AKI | 72 hours | Serum and urine will be collected for biomarker discovery. |
| Hospitalization | Duration of post-operative hospitalization | Number of post-operative days in cardiac intensive care unit (CICU) and hospital. |
Countries
United States
Outcome results
None listed