Cerebral Protection in Aortic Arch Surgery

Sponsor
Barts & The London NHS Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04966247
Collaborator
Queen Mary University of London (Other), Imperial College London (Other)
40
28

Study Details

Study Description

Brief Summary

Aortic arch repair surgery is a technically complex and challenging procedure to treat aortic pathologies. Despite advancements in perioperative care, detrimental neurological complications occur during or after surgery. The neurological complications increase the economic burden of healthcare, morbidity and quality of life for the patients, even if they survive. Stroke, for example, leads to an increase in healthcare and social care costs, requiring a subsequent lengthy rehabilitation. Milder neurological impairments include transient ischaemic attacks, confusion and delirium, necessitating longer intensive care and hospital stay.

Currently applied cerebral monitoring modalities are electroencephalogram and cerebral oximetry, and they are not specific enough to timely detect early cerebral ischaemia to prevent the neurological complications. S100B protein, neuron-specific enolase, and glial fibrillary acidic protein are serum markers that reflect cerebral damage, however, their applicability in the hyperacute setting is limited. Recent studies reveal more sensitive biomarkers of glucose, lactate, pyruvate, glutamate and glycerol. These biomarkers could potentially detect cerebral ischaemia on a real time basis using continuous microdialysis method. The primary aim of the project is to develop a bedside system to continuously monitor and detect cerebral ischaemia on a real time basis during surgery and in the intensive care unit.

Central venous catheters are routinely used to monitor central venous pressure, sampling blood and administration of medications during surgery and intensive care stay. Microdialysis catheter can collect blood dialysate directly from the central venous catheter, and cerebral ischaemic biomarkers can be monitored continuously. Immediate detection of cerebral ischaemia could mandate more aggressive cerebral protection strategies by further optimisation of hypothermia and antegrade selective cerebral perfusion during surgery, and optimisation of blood pressure and oxygenation in the intensive care unit. Ultimately, early detection of cerebral ischemia using microdialysis during surgery will prevent disabling and costly neurological complications following surgery.

Condition or Disease Intervention/Treatment Phase
  • Other: Microdialysis

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cerebral Protection in Aortic Arch Surgery
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Patients with Aortic Arch Pathology

Patients undergoing aortic arch surgery for aortic arch pathologies, such as aortic aneurysm and aortic dissection.

Other: Microdialysis
Monitoring real-time cerebral biomarkers using microdialysis method

Outcome Measures

Primary Outcome Measures

  1. Number of participants with postoperative stroke [From the start of surgery until patient is discharged from the hospital, an average of 7 days]

    New onset stroke after surgery

Secondary Outcome Measures

  1. Number of participants with postoperative delirium [From the start of surgery until patient is discharged from the hospital, an average of 7 days]

    New onset delirium after surgery will be assessed using the "Confusion Assessment Method (CAM)"

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients undergoing aortic arch surgery

  • Patients aged 18 and over

  • Patients who are able to provide informed consent

Exclusion Criteria:
  • Patients with intraoperative death

  • Patients with preoperative neurological dysfunction

  • Patients who are not able to provide informed consent (language barrier, unconscious, unable to understand, retain and process information)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Barts & The London NHS Trust
  • Queen Mary University of London
  • Imperial College London

Investigators

  • Principal Investigator: Aung Ye Oo, MD, FRCS-CTh, Queen Mary University London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT04966247
Other Study ID Numbers:
  • 299015
First Posted:
Jul 19, 2021
Last Update Posted:
Mar 8, 2022
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022