AKINCT04112953
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
An observational study of AKI, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2019to 15 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Inclusion criteria are patients >18 years old getting elective cardiac surgery with the use of cardiopulmonary bypass at the University of Chicago Medical Center.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- AKI
- Keywords
- transesophagel echocardiography cardiac surgery kidney function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Portal vein pulsatility
Pulsed-wave Doppler measurement of portal vein flow and portal hypertension
Measured: intra-operative measurement
Secondary outcomes (4)
Renal resistance index
A sonographic index to assess for renal arterial disease measured via pulsed-wave Doppler
Measured: intra-operative measurement
ICU length of stay
Length of ICU stay at any point for 30 days post-operation will be recorded
Measured: 30 days post-operation
Hospital length of stay
Length of Hospital stay up to 30 days post-operation will be recorded
Measured: 30 days post-operation
30-day mortality
Standard measure post
Measured: 30 day post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start4 Sep 2019
- Primary completion5 Apr 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKIStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112953
- Sponsor's protocol ID
- TEE PF/RRI AKI IRB19-0599
- Status last verified
- Jul 2023
- First submitted
- 4 Sep 2019
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04112953
- Acronym / sponsor ID
- TEE PF/RRI AKI IRB19-0599
- Conditions
- AKI
- Keywords
- transesophagel echocardiography cardiac surgery kidney function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Inclusion criteria are patients >18 years old getting elective cardiac surgery with the use of cardiopulmonary bypass at the University of Chicago Medical Center.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Portal vein pulsatility
Time frame: intra-operative measurement
Pulsed-wave Doppler measurement of portal vein flow and portal hypertension
4 secondary outcomes
Renal resistance index
Time frame: intra-operative measurement
ICU length of stay
Time frame: 30 days post-operation
Hospital length of stay
Time frame: 30 days post-operation
30-day mortality
Time frame: 30 day post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AKI, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portal vein pulsatility (time frame: intra-operative measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.