Organ Failure After Advanced Endovascular Thoracoabdominal Aortic Surgery

Aortic Aneurysm Clinical Trial

— ODEA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03136536
• Other study ID #: 206471
• Status: Recruiting
• Start date: May 3, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Region Örebro County
• Contact: Kristofer F Nilsson, MD, PhD
• Phone: 196020352
• Email: kristofer-bo-ingemar.nilsson[@]regionorebrolan.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Accepted for endovascular advanced thoracoabdominal aortic surgical procedure

• Adult

Exclusion Criteria:

• Pregnant

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Gastrointestinal Ischaemia
• Ischemia
• Spinal Ischaemia

Locations

Country	Name	City	State
Sweden	Department of Cardio-thoracic and Vascular Surgery, Örebro University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proteomics	Plasma, urine, cerebrospinal fluid, intraperitoneal microdialysate	Postoperative: 7 days
Primary	Mortality	Overall and aortic-related mortality	1 year postoperative
Secondary	Organ dysfunction and failure	Spinal cord, gastrointestinal tract, kidneys	Postoperative: 7 days, 30 days, 1 year follow-up