Clinical trial NCT04112953: Intraoperative Transesophageal Echocardiography Assessment of Portal Vein Flow and Renal Resistive Index As a Predictor of Acute Kidney Injury After Cardiac Surgery: A Prospective Observational Study
Official title: Intraoperative Transesophageal Echocardiography Assessment of Portal Vein Flow and Renal Resistive Index As a Predictor of Acute Kidney Injury After Cardiac Surgery: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AKI
Keywords: transesophagel echocardiography cardiac surgery kidney function
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be included who are scheduled for a standard of care cardiac surgery with the use of cardiopulmonary bypass at the University of Chicago Medical Center who meet the study's inclusion and exclusion criteria.

Brief summary: The purpose of this study is to better understand if transesophageal echocardiography during cardiac surgery can predict problems with kidney function after cardiac surgery.

Detailed description: Informed consent will be obtained prior to surgery. Preoperative demographic and baseline clinical data will be collected. We will assess the patient's risk of postoperative AKI using the validated Cleveland clinic score based on preoperative risk factors and calculate the European System Operative Score Risk Evaluation score (EuroSCORE II). After standard anesthesia induction and intubation, a TEE probe will be inserted by a cardiac anesthesiologist, who is certified in intraoperative echocardiography. We will use a standard ultrasound machine (EPIQ 7 Philips;Philips, Bothell, WA). Images of the right or left kidney along with Doppler flow and velocities will be obtained prior to cardiopulmonary bypass (CPB), after CPB, and after chest closure. Images of the portal vein with Doppler flow and velocity will be obtained prior to CPB, after CPB, and after chest closure. Vitals signs and hemodynamic data will be collected concurrently during these times. (See Data Sheet) Concurrent ECG will be obtained to identify the phases of the cardiac cycle. Mean arterial pressure (MAP) will be maintained within 20% of baseline MAP with bolus or continuous infusion of vasopressors (phenylephrine, norepinephrine, epinephrine, vasopressin, ephedrine). Cardiopulmonary bypass management will be standard, with target systemic blood flow of 2.4L/min/m2. Postoperative data will include urine output, serum creatinine, calculated GFR (using Modification of Diet in Renal Disease \[MDRD\] method) hospital and ICU length of stay, and 30-day mortality.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria are patients \>18 years old getting elective cardiac surgery with the use of cardiopulmonary bypass at the University of Chicago Medical Center.

Exclusion Criteria:

* Exclusion criteria are preexisting renal insufficiency/failure (glomerular filtration rate \< 60 ml/min/1.73 m2 \[stage 2 chronic kidney disease\] or dialysis, renal vein thrombosis, renal artery stenosis, significant aortic regurgitation (moderate to severe aortic regurgitation on preoperative or intraoperative TEE), liver cirrhosis, portal vein thrombosis, preoperative intra-aortic counterpulsation balloon pump, emergency surgery, inability to obtain flow velocity waveforms of renal/portal vasculature on TEE, and kidney or liver transplant.

Primary outcomes:
measure: Portal vein pulsatility
timeFrame: intra-operative measurement
Secondary outcomes:
measure: Renal resistance index
timeFrame: intra-operative measurement
measure: ICU length of stay
timeFrame: 30 days post-operation
measure: Hospital length of stay
timeFrame: 30 days post-operation
measure: 30-day mortality
timeFrame: 30 day post-operation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
References: