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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL151882 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass.
Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass for cardiac surgery are both considered standard of care and allow surgeons to operate on the heart without movement. Pulsatile cardiopulmonary bypass produces variations in blood flow to produce a pulse similar to a normal beating heart. Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass are approved as safe and effective ways to provide perfusion during cardiac surgery, but it is unknown whether there are differences in clinical outcomes after surgery. Acute kidney injury is common after cardiac surgery and may be caused by inadequate perfusion during cardiopulmonary bypass.
Specific Aim: The purpose of this study is to determine the effectiveness of pulsatile blood flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.
Hypothesis: Pulsatile blood flow during cardiopulmonary bypass will reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-pulsatile blood flow | Active Comparator | Non-pulsatile blood flow during cardiopulmonary bypass |
|
| Pulsatile blood flow | Active Comparator | Pulsatile blood flow during cardiopulmonary bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-pulsatile blood flow | Other | Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury | Stage 1 (mild), 2 (moderate), or 3 (severe) acute kidney injury according to the Kidney Disease Improving Global Outcomes creatinine criteria (stage 1 = 1.5 to 1.9 times baseline or greater than or equal to 0.3 milligrams per deciliter increase in serum creatinine, stage 2 = 2.0 to 2.9 times baseline in serum creatinine, stage 3 = 3.0 times baseline or increase in serum creatinine greater than or equal to 4.0 milligrams per deciliter or initiation of renal replacement therapy | From intensive care unit admission after surgery up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury risk score | Demirjian Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery in percent predicted risk | On admission to the intensive care unit after surgery up to 24 hours after intensive care unit arrival |
| Red blood cell units transfused |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarction | Myocardial infarction by clinical diagnosis | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| Stroke | Stroke by clinical diagnosis |
Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathan J Clendenen, MD,MS | Contact | 3037245000 | nathan.clendenen@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nathan J Clendenen, MD, MS | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35258532 | Background | Demirjian S, Bashour CA, Shaw A, Schold JD, Simon J, Anthony D, Soltesz E, Gadegbeku CA. Predictive Accuracy of a Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery. JAMA. 2022 Mar 8;327(10):956-964. doi: 10.1001/jama.2022.1751. | |
| 22890468 | Background | Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D006461 | Hemolysis |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Pulsatile blood flow | Other | Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass |
|
Number of allogenic red blood cell units transfused after cardiopulmonary bypass |
| After cardiopulmonary bypass up to 24 hours after intensive care unit arrival |
| Platelet nadir | Lowest platelet count after cardiopulmonary bypass | On admission to the intensive care unit after surgery up to 7 days |
| Discontinuation rate of cardiopulmonary bypass mode | Discontinuation rate of pulsatile or non-pulsatile cardiopulmonary bypass mode | During cardiopulmonary bypass |
| 30-day mortality | All cause mortality | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| Renal failure requiring renal replacement therapy | New diagnosis of renal failure requiring renal replacement therapy | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| Re-exploration for bleeding | Surgical re-exploration for bleeding | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| Sepsis | Diagnosed by positive blood culture | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| New onset atrial fibrillation | Clinical diagnosis of new onset atrial fibrillation | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| Duration of mechanical ventilation | Duration of mechanical ventilation | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| Post-operative delirium | Post-operative determined by the Confusion Assessment Method for the Intensive Care Unit | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| Post-operative hospital length of stay | Post-operative hospital length of stay | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| New requirement for mechanical circulatory support | New requirement for mechanical circulatory support | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| Intra-operative red blood cell transfusion in units | Intra-operative red blood cell transfusion in units | During the intra-operative time period, up to 12 hours |
| Post-operative red blood cell transfusion in units | Post-operative red blood cell transfusion in units | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| Post-operative platelet transfusion in units | Post-operative platelet transfusion in units | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| Post-operative plasma transfusion in units | Post-operative plasma transfusion in units | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| Post-operative cryoprecipitate transfusion in units | Post-operative cryoprecipitate transfusion in units | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| Intra-operative platelet transfusion in units | Intra-operative platelet transfusion in units | During the intra-operative time period, up to 12 hours |
| Intra-operative plasma transfusion in units | Intra-operative plasma transfusion in units | During the intra-operative time period, up to 12 hours |
| Intra-operative cryoprecipitate transfusion in units | Intra-operative cryoprecipitate transfusion in units | During the intra-operative time period, up to 12 hours |
| New onset of acute lung injury | Diagnosis of acute lung injury by PaO2 to FiO2 ratio ≤ 300 | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| New onset of left ventricular systolic dysfunction | New onset of left ventricular systolic dysfunction determined by a LV ejection fraction <50% | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| New onset of right ventricular systolic dysfunction | New onset of right ventricular systolic dysfunction determined by a tricuspid annular plane systolic excursion less than 16 mm | From intensive care unit admission after surgery to hospital discharge, up to 30 days |
| 36380831 | Background | Tan A, Newey C, Falter F. Pulsatile Perfusion during Cardiopulmonary Bypass: A Literature Review. J Extra Corpor Technol. 2022 Mar;54(1):50-60. doi: 10.1182/ject-50-60. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |