NCT04112953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

September 4, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

2.6 years

First QC Date

September 4, 2019

Last Update Submit

July 20, 2023

Conditions

AKI

Keywords

transesophagel echocardiography cardiac surgery kidney function

Outcome Measures

Primary Outcomes (1)

  • Portal vein pulsatility

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

    intra-operative measurement

Secondary Outcomes (4)

  • Renal resistance index

    intra-operative measurement

  • ICU length of stay

    30 days post-operation

  • Hospital length of stay

    30 days post-operation

  • 30-day mortality

    30 day post-operation

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2019

First Posted

October 2, 2019

Study Start

September 4, 2019

Primary Completion

April 5, 2022

Study Completion

November 15, 2022

Last Updated

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared

Locations

US(1)