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Organ Failure After Advanced Endovascular Thoracoabdominal Aortic Surgery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03136536
Acronym
ODEA
Enrollment
60
Registered
2017-05-02
Start date
2017-05-03
Completion date
2022-12-31
Last updated
2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Gastrointestinal Ischaemia, Spinal Ischaemia

Brief summary

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.

Interventions

None listed

Sponsors

Region Örebro County
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Accepted for endovascular advanced thoracoabdominal aortic surgical procedure * Adult

Exclusion criteria

* Pregnant

Design outcomes

Primary

MeasureTime frameDescription
Mortality1 year postoperativeOverall and aortic-related mortality

Secondary

MeasureTime frameDescription
Organ dysfunction and failurePostoperative: 7 days, 30 days, 1 year follow-upSpinal cord, gastrointestinal tract, kidneys

Other

MeasureTime frameDescription
ProteomicsPostoperative: 7 daysPlasma, urine, cerebrospinal fluid, intraperitoneal microdialysate

Countries

Sweden

Contacts

Primary ContactKristofer F Nilsson, MD, PhD
kristofer-bo-ingemar.nilsson@regionorebrolan.se196020352

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026