- ICH GCP
- US Clinical Trials Registry
- 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
July 20, 2023 updated by: University of Chicago
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Al McAuley
- Phone Number: 7738343274
- Email: amcauley1@dacc.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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
Time Frame: intra-operative measurement
|
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
Time Frame: intra-operative measurement
|
A sonographic index to assess for renal arterial disease measured via pulsed-wave Doppler
|
intra-operative measurement
|
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
|
30 days post-operation
|
Hospital length of stay
Time Frame: 30 days post-operation
|
Length of Hospital stay up to 30 days post-operation will be recorded
|
30 days post-operation
|
30-day mortality
Time Frame: 30 day post-operation
|
Standard measure post
|
30 day post-operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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