N/A
N=460
Cerebral Autoregulation Monitoring During Cardiac Surgery
Thoracic Surgery · Cardiopulmonary Bypass
Bottom Line
View on ClinicalTrials.gov: NCT00981474 ↗Enrolled (actual)
460
Serious AEs
55.2%
Results posted
Mar 2021
Primary outcome: Primary: Composite Neurological Outcome of Clinical Stroke or New Ischemic Brain Lesion on Diffusion Weighted MRI or Neurocognitive Dysfunction 4 to 6 Weeks After Surgery. — 79; 70 Participants — p=.752
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- blood pressure maintenance based on cerebral blood flow autoregulation measurement (Drug); Control group (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Neurological Outcome of Clinical Stroke or New Ischemic Brain Lesion on Diffusion Weighted MRI or Neurocognitive Dysfunction 4 to 6 Weeks After Surgery. |
79; 70 | .752 |
| SECONDARY Postoperative Delirium |
34; 19 | .053 |
| SECONDARY Multiple Inotropic Drugs>24 Hours After Surgery |
13; 6 | .149 |
| SECONDARY Mechanical Lung Ventilation>24 Hours After Surgery |
22; 13 | .144 |
| SECONDARY Insertion of Intra-aortic Balloon Pump |
19; 14 | .439 |
| SECONDARY Postoperative Atrial Fibrillation |
89; 79 | .311 |
| SECONDARY Sepsis |
7; 2 | .103 |
| SECONDARY Acute Kidney Injury Within 7 Days After Surgery. |
56; 62 | .608 |
| SECONDARY New Renal Replacement Therapy |
6; 4 | .541 |
| SECONDARY Multisystem Organ Failure After Surgery |
7; 2 | .103 |
| SECONDARY Mortality |
12; 5 | .129 |
Summary
Neurological complications from cardiac surgery are an important source of operative mortality, prolonged hospitalization, health care expenditure, and impaired quality of life. New strategies of care are needed to avoid rising complications for the growing number of aged patients undergoing cardiac surgery. This study will evaluate novel methods for reducing brain injury during surgery from inadequate brain blood flow using techniques that could be widely employed.
Eligibility Criteria
Inclusion Criteria
- Male or female patients undergoing primary or re-operative Coronary Artery Bypass Graft (CABG) and/or valvular surgery or ascending aorta surgery that requires Cardio-pulmonary bypass (CPB) who are at high risk for neurologic complications (stroke or encephalopathy) as determined by a Johns Hopkins risk score of >0.02
Exclusion Criteria
- Contraindication to MRI imaging (e.g., permanent pacemaker, cerebral arterial vascular clips)
- Liver function test before surgery more than twice the upper limit of institutional normal
- Pre-existing renal dysfunction defined as an estimated glomerular filtration rate of ≤60 mL/min, or current renal dialysis
- Emergency surgery
- Inability to attend outpatient visits
- Visual impairment or inability to speak and read English. The patient will be excluded from further study if an adequate temporal window for Transcranial Doppler (TCD) monitoring can not be identified before surgery.
Data sourced from ClinicalTrials.gov (NCT00981474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.