Prediction of Acute Kidney Injury After Operation of Acute Type A Aortic Dissection Based on Multimodal Model

August 23, 2021 updated by: Qilu Hospital of Shandong University
Acute kidney injury is one of the most common postoperative complications of acute type A aortic dissection, which is closely related to early postoperative death. Early prevention, early diagnosis and early treatment are the key to improve the prognosis of such patients. It has been a hot topic in clinical research for a long time. Previous reports revealed a series of risk factors for acute kidney injury after aortic dissection, but limited by research design and single modal data, high quality studies were rare. The purpose of this study is to further clarify the risk factors by studying the relationship between preoperative CT renal perfusion imaging indexes and postoperative acute kidney injury; establish and externally verify the multimodal radiomics prediction model for acute kidney injury after operation of aortic dissection combining with preoperative CT renal perfusion imaging and CT angiography information by analysis methods of information fusion, feature engineering and radiomics, so as to guide the follow-up clinical practice, improve the prognosis of such patients and save medical resources.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

242

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

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 to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients sufferred acute type A aortic dissection.

Description

Inclusion Criteria:

  1. 18-70 years old
  2. Acute type A aortic dissection diagnosed by CT angiography
  3. Sign informed consent

Exclusion Criteria:

  1. History of chronic kidney disease
  2. History of cardiovascular operation
  3. Acute kidney injury has occurred before operation
  4. Pregnancy status

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
Intervention / Treatment
Normal Perfusion
Diagnostic test: Normal CT Renal Perfusion imaging indexes
A CT imaging which indicates the status of renal perfusion is normal.
Low Perfusion
Diagnostic test: Low CT Renal Perfusion imaging indexes
A CT imaging which indicates the status of renal perfusion is low.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury after operation
Time Frame: From date of operation until the date of acute kidney injury or date of death from any cause, whichever came first, assessed up to 30 days.
Yes; No
From date of operation until the date of acute kidney injury or date of death from any cause, whichever came first, assessed up to 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

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 (ANTICIPATED)

September 1, 2021

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

February 1, 2023

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (ACTUAL)

August 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020SDUCRCC031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device 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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