Organ Failure After Advanced Endovascular Thoracoabdominal Aortic Surgery

NCT ID: NCT03136536

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-03
• Study Completion Date: 2022-12-31

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.

Conditions

Aortic Aneurysm; Spinal Ischaemia; Gastrointestinal Ischaemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Accepted for endovascular advanced thoracoabdominal aortic surgical procedure
• Adult

Exclusion Criteria

• Pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristofer F Nilsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardio-thoracic and Vascular Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden

Locations

Department of Cardio-thoracic and Vascular Surgery, Örebro University Hospital

Örebro, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Kristofer F Nilsson, MD, PhD

Role: CONTACT

kristofer-bo-ingemar.nilsson@regionorebrolan.se

196020352 ext. +46

Facility Contacts

Kristofer F Nilsson, MD, PhD

Role: primary

kristofer-bo-ingemar.nilsson@regionorebrolan.se

196020352 ext. +46

Other Identifiers

206471

Identifier Type: -

Identifier Source: org_study_id