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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Ischemic Preconditioning (RIPC) | Experimental |
| |
| Control | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIPC | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute kidney injury (AKI) | Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3. | 72 hours |
| Incidence of acute myocardial injury | Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute lung injury | Days on mechanical ventilation, readiness for extubation. | 72 hours and duration of hospitalization |
| Hospitalization | Number of post-operative days in cardiac intensive care unit (CICU) and hospital. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Christine W Hsu, MD | Seattle Children's Hospital and University of Washington | Principal Investigator |
| Yuk Law, MD | Seattle Children's Hospital and University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38172875 | Derived | Law YM, Hsu C, Hingorani SR, Richards M, McMullan DM, Jefferies H, Himmelfarb J, Katz R. Randomized controlled trial of remote ischemic preconditioning in children having cardiac surgery. J Cardiothorac Surg. 2024 Jan 3;19(1):5. doi: 10.1186/s13019-023-02450-8. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D058186 | Acute Kidney Injury |
| D055371 | Acute Lung Injury |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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|
| Control | Procedure | In OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes. |
|
| Duration of post-operative hospitalization |
| Mortality | Duration of hospitalization, 30 days post-op, and at last follow-up |
| Biomarkers for AKI | Serum and urine will be collected for biomarker discovery. | 72 hours |
| Inflammation | Cytokines will be measured at baseline until 72 hours post-operative. | 72 hours |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |