Cerebral Blood Supply During Cardiopulmonary Bypass

NCT03117712 | Completed

• 1 other identifier: 1964/2016
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative delirium is an acute and fluctuating state of confusion and disorientation with an incidence of 25-70% after cardiac surgery. Possible reasons for this multifactorial complication are hypoperfusion, cerebral microembolization and inflammatory response, which eventually lead to regional or global imbalance between cerebral oxygen demand and supply. Adequate cerebral blood supply depends sufficient blood supply via the vertebral arteries and the internal carotid arteries. The aim of this preliminary study is to investigate if patients who develop delirium after open-heart surgery show differences in their cerebral blood flow during cardiopulmonary bypass (CPB) in extracerebral arterial vessels compared to those patients without delirium.

Conditions

Postoperative Delirium

Keywords

cerebral blood supply; cardiopulmonary bypass; open-heart cardiac surgery

Outcome Measures

Primary Outcomes (1)

• cerebral blood flow

  Differences in mean laminar cerebral blood flow on cardiopulmonary bypass during open heart surgery between patients with and without postoperative delirium

  during surgery

Secondary Outcomes (1)

• HITS (high-intensity transient signals)

  during surgery

Study Arms (2)

Delirium

patients who develop postoperative delirium after surgery with cardiopulmonary bypass measured by Delirium scores (CAM-ICU, ICDSC), TCD for detection of HITS and carotis duplex sonography

Diagnostic Test: Delirium Scores; Diagnostic Test: Carotis duplex sonography; Diagnostic Test: TCD for detection of HITS

No delirium

patients who develop no postoperative delirium after surgery with cardiopulmonary bypass measured by delirium scores (CAM-ICU, ICDSC), TCD for detection of HITS and carotis duplex sonography

Diagnostic Test: Delirium Scores; Diagnostic Test: Carotis duplex sonography; Diagnostic Test: TCD for detection of HITS

Interventions

Delirium Scores DIAGNOSTIC_TEST

* Confusion Assessment method for the ICU (CAM-ICU) and * The Intensive Care Delirium Screening Checklist (ICDSC) Delirium Scores will be measured at the following timepoints: 1. Postoperative day (POD) 1 2. POD 2 3. POD 5

Delirium; No delirium

Carotis duplex sonography DIAGNOSTIC_TEST

Carotis duplex sonography for perfusion flow will be evaluated at the following timepoints: 1. Before induction of anaesthesia 2. Before going on cardiopulmonary bypass (CBP) 3. During CPB, 5 min after aortic cross clamping 4. After CPB 5. 24 hours after CPB

Delirium; No delirium

TCD for detection of HITS DIAGNOSTIC_TEST

Transcranial Doppler ultrasound (TCD) for detection and differentiation of high-intensity transient signals (HITS) in both middle cerebral arteries (MCAs) into artefacts, solid, and gaseous cerebral microemboli (CME) will be performed at the following timepoints: 1. During cannulation of the ascending aorta 2. After aortic cross-clamp 3. After opening of the aortic cross-clamp 4. During decannulation

Delirium; No delirium

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elective cardiac surgical patients undergoing valve replacement/reconstruction surgery on cardiopulmonary bypass.

You may qualify if:

• elective cardiac surgery valve replacement/reconstruction cardiopulmonary bypass

You may not qualify if:

• Emergency procedures
• Postoperative need for extracorporal cardiac assist device
• Untreated or uncontrolled arterial hypertension
• Profound hypothermic CPB (body temperature \<34°C)
• History of preoperative dementia
• History of Stroke
• Significant carotid artery stenosis
• Age \< 18 years
• Chronic renal replacement therapy
• Declined informed consent

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical university of vienna, General hospital of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Ulrike Weber, M.D.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof.Dr.

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 18, 2017
• Study Start: May 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)