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OpenTrials
Completed

NCT Number: 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

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

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Key information

Conditions

AKI

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Portal vein pulsatility

    Time frame: intra-operative measurement

    Pulsed-wave Doppler measurement of portal vein flow and portal hypertension

Secondary outcomes

  1. Renal resistance index

    Time frame: intra-operative measurement

    A sonographic index to assess for renal arterial disease measured via pulsed-wave Doppler

  2. ICU length of stay

    Time frame: 30 days post-operation

    Length of ICU stay at any point for 30 days post-operation will be recorded

  3. Hospital length of stay

    Time frame: 30 days post-operation

    Length of Hospital stay up to 30 days post-operation will be recorded

  4. 30-day mortality

    Time frame: 30 day post-operation

    Standard measure post

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 2, 2019
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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