- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03136536
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
Status
Recruiting
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
- Name: Kristofer F Nilsson, MD, PhD
- Phone Number: +46 196020352
- Email: kristofer-bo-ingemar.nilsson@regionorebrolan.se
Study Locations
-
-
-
Örebro, Sweden
- Recruiting
- Department of Cardio-Thoracic and Vascular Surgery, Örebro University Hospital
-
Contact:
- Kristofer F Nilsson, MD, PhD
- Phone Number: +46 196020352
- Email: kristofer-bo-ingemar.nilsson@regionorebrolan.se
-
-
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 206471
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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