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

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

Study Overview

• Status: Completed
• Conditions: AKI

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

• Study Contact: Name: Al McAuley; Phone Number: 7738343274; Email: amcauley1@dacc.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Upcoming cardiac surgery; Subjects in this group will have an upcoming cardiac surgery with the use of cardiopulmonary bypass and no pre-existing renal insufficiency or failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Portal vein pulsatility	Pulsed-wave Doppler measurement of portal vein flow and portal hypertension	intra-operative measurement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal resistance index	A sonographic index to assess for renal arterial disease measured via pulsed-wave Doppler	intra-operative measurement
ICU length of stay	Length of ICU stay at any point for 30 days post-operation will be recorded	30 days post-operation
Hospital length of stay	Length of Hospital stay up to 30 days post-operation will be recorded	30 days post-operation
30-day mortality	Standard measure post	30 day post-operation

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): April 5, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: transesophagel echocardiography cardiac surgery kidney function
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury
• Other Study ID Numbers: TEE PF/RRI AKI IRB19-0599

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No