Organ Failure After Advanced Endovascular Thoracoabdominal Aortic Surgery (ODEA)

March 8, 2021 updated by: Region Örebro County

Kärlkirurgi Vid Komplicerade kroppspulsåderbråck - Utfall, Riskfaktorer Och sökande Efter biomarkörer för Organskada

The purpose of this study is to investigate the mortality and frequency of organ dysfunction in patients after endovascular thoracoabdominal aortic surgery, and to search for biomarkers of organ dysfunction, in particular the spinal cord, the kidneys and the gastrointestinal tract. All adult patients undergoing endovascular thoracoabdominal aortic surgery at Örebro University Hospital, Örebro, Sweden, are asked for participation in this study. All participating patients sign informed consent at the inclusion. During the operation and during the postoperative intensive care, the function of the spinal cord, the gastrointestinal tract and the kidneys are collected along with other clinical parameters. Plasma blood samples, urin samples and cerebrospinal fluid samples are collected from each patient during the operation and during the postoperative care at the intensive care unit. During the operation two microdialysis catheters are placed in the abdomen, and the samples are continuously collected and analyzed. The biomaterial samples are stored in a biobank for later determination of proteins and other molecules. Postoperative survival and the frequency of complications are analysed.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

60

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

Study Locations

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients undergoing endovascular advanced thoracoabdominal aortic surgical procedures at Örebro University Hospital, Örebro, Sweden.

Description

Inclusion Criteria:

  • Accepted for endovascular advanced thoracoabdominal aortic surgical procedure
  • Adult

Exclusion Criteria:

  • Pregnant

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 1 year postoperative
Overall and aortic-related mortality
1 year postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Organ dysfunction and failure
Time Frame: Postoperative: 7 days, 30 days, 1 year follow-up
Spinal cord, gastrointestinal tract, kidneys
Postoperative: 7 days, 30 days, 1 year follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proteomics
Time Frame: Postoperative: 7 days
Plasma, urine, cerebrospinal fluid, intraperitoneal microdialysate
Postoperative: 7 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Kristofer F Nilsson, MD, PhD, Department of Cardio-thoracic and Vascular Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden

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)

May 3, 2017

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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