A Comparison of Renal Vs Limb NIRS for Predicting Cardiac Surgery Associated Acute Kidney Injury
- Registration Number
- NCT06705855
- Lead Sponsor
- University of Utah
- Brief Summary
Acute kidney injury (AKI) is a complication of cardiac surgery that can affect outcome. Near Infrared Spectroscopy (NIRS) is a technology that uses light to determine how well oxygenated tissues are. This technology is routinely used in cardiac surgery to measure the oxygen level in the brain by placing a sensor sticker on the forehead. The purpose of the st...
- Detailed Description
Acute kidney injury (AKI) is a common complication of cardiac surgery occurring in up to 40% of patients.1, 2 This is more than 10 times the rate of other serious post-surgical complications in cardiac surgery such as stroke or deep sternal infection and is even greater than the incidence of prolonged ventilation.3, 4 Severe AKI requiring new onset dialysis ...
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- We will enroll a convenience sample of adult cardiac surgery patients undergoing procedures that require cardiopulmonary bypass (CPB) and who are at risk for AKI.
- Exclusion criteria will include less than age 18 years old, preoperative end-stage kidney disease requiring dialysis, emergency surgery, or patient refusal.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of post-operative acute kidney injury (AKI) in adult cardiac surgery patients From post-operative day 0 to post-operative day 7(KDIGO stage I AKI) The objective of this study is to compare perioperative renal NIRS and limb NIRS and determine whether these measurements can predict acute kidney injury in adult cardiac surgery patients. The primary outcome will be the as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. Measured by an increase in serum creatinine greater than 0....
- Secondary Outcome Measures
Name Time Method The development of severe acute kidney injury (AKI) From post-operative day 0 to post-operative day 7(KDIGO stage I AKI) Post-operative AKI as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. Measured by an increase in serum creatinine greater than 2.0 - 2.9 times baseline (KDIGO stage 2) or an increase in serum creatinine greater than 3.0 times baseline or greater than 4mg/dl or the initiation of renal replacement therapy (KDIGO stage 3)
Ventilator times From post-operative day 0 to end of hospital stay, up to 3 months Length of time patient is on ventilator
ICU and hospital length of stay From post-operative day 0 to end of hospital stay, up to 3 months Time patient is in pre-operation (pre-cardiopulmonary bypass(CPB)), operation (CPB), Post-operation (post-CPB), and ICU.
In-hospital mortality From post-operative day 0 to end of hospital stay, up to 3 months Number of in-hospital, operative and/or post-operative (cardiopulmonary bypass) deaths
Intraoperative hemodynamic changes, mean arterial pressure From start of surgery to end of surgery, up to 24 hours Blood pressure (mmHg) readings will be recorded.
Intraoperative hemodynamic changes, oxygen delivery From start of surgery to end of surgery, up to 24 hours Oxygen delivery readings during cardiopulmonary bypass will be recorded (Sp02 using pulse oximeter, measured in liters per minute (LPM)).
Intraoperative hemodynamic changes, vasopressor administration From start of surgery to end of surgery, up to 24 hours Vasopressor agent (mcg/kg/min) use will be recorded.
Intraoperative hemodynamic changes, anemia From start of surgery to end of surgery, up to 24 hours Intraoperative anemia will be measured on both NIRS measurements, expressed as a % (regional SO2 (rS02)).
Trial Locations
- Locations (1)
University of Utah
🇺🇸Salt Lake City, Utah, United States