Organ Failure After Advanced Endovascular Thoracoabdominal Aortic Surgery

• Conditions: Aortic Aneurysm; Gastrointestinal Ischaemia; Spinal Ischaemia

• Registration Number: NCT03136536
• Lead Sponsor: Region Örebro County

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-02
• Study Start: 2017-05-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Accepted for endovascular advanced thoracoabdominal aortic surgical procedure
• Adult

Exclusion Criteria

• Pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	1 year postoperative	Overall and aortic-related mortality

Secondary Outcome Measures

Name	Time	Method
Organ dysfunction and failure	Postoperative: 7 days, 30 days, 1 year follow-up	Spinal cord, gastrointestinal tract, kidneys

Trial Locations

Locations (1)

Department of Cardio-thoracic and Vascular Surgery, Örebro University Hospital; 🇸🇪 Örebro, Sweden