Trial Outcomes & Findings for Cerebral Autoregulation Monitoring During Cardiac Surgery (NCT NCT00981474)
NCT ID: NCT00981474
Last Updated: 2021-03-02
Results Overview
The composite neurological outcome was composed of clinical stroke, or new ischemic lesions detected on postoperative brain diffusion weighted magnetic resonance imaging(DWI), or cognitive decline from baseline to 4-6 weeks after surgery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
460 participants
Primary outcome timeframe
Up to 6 weeks post-operative
Results posted on
2021-03-02
Participant Flow
After obtaining written informed consent, 468 were randomized to the two groups. 237 in the autoregulation group were randomized after consent and 5 subjects withdrew consent. 231 in the usual care group were randomized after consent and 3 subjects withdrew consent.
Participant milestones
| Measure |
Usual Care Group (Control)
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
Blood pressure management based on cerebral autoregulation data.
blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
Overall Study
STARTED
|
228
|
232
|
|
Overall Study
COMPLETED
|
228
|
232
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cerebral Autoregulation Monitoring During Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Usual Care Group
n=228 Participants
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=232 Participants
Blood pressure management based on cerebral autoregulation data.
blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
Total
n=460 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
70.0 years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
70.4 years
STANDARD_DEVIATION 7.6 • n=206 Participants
|
|
Sex/Gender, Customized
Female
|
67 participants
n=99 Participants
|
62 participants
n=107 Participants
|
129 participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
160 participants
n=99 Participants
|
170 participants
n=107 Participants
|
330 participants
n=206 Participants
|
|
Sex/Gender, Customized
Missing designation
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
189 participants
n=99 Participants
|
184 participants
n=107 Participants
|
273 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
24 participants
n=99 Participants
|
28 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
228 Participants
n=99 Participants
|
232 Participants
n=107 Participants
|
460 Participants
n=206 Participants
|
|
Highest Grade of Formal Education (median,[inter-quartile range])
|
14.0 Years
n=99 Participants
|
14.5 Years
n=107 Participants
|
14 Years
n=206 Participants
|
|
Mini-Mental State Exam
|
28 score on a scale (30 good- 0 poor)
n=99 Participants
|
28 score on a scale (30 good- 0 poor)
n=107 Participants
|
28 score on a scale (30 good- 0 poor)
n=206 Participants
|
|
History of a prior stroke
|
25 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
History of hypertension
|
213 Participants
n=99 Participants
|
207 Participants
n=107 Participants
|
420 Participants
n=206 Participants
|
|
History of atrial fibrillation
|
53 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
History of myocardial infarction
|
65 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
History of chronic obstructive lung disease
|
31 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Obstructive sleep apnea
|
41 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Current tobacco use
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
History of diabetes
|
101 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
209 Participants
n=206 Participants
|
|
History of anemia
|
101 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
209 Participants
n=206 Participants
|
|
Logistic EuroSCORE (median,[interquartile range])
|
5.3 score on a scale 0-2 good >=5 high risk
n=99 Participants
|
5.08 score on a scale 0-2 good >=5 high risk
n=107 Participants
|
5.19 score on a scale 0-2 good >=5 high risk
n=206 Participants
|
|
Cardiopulmonary bypass duration
|
107 Minutes
n=99 Participants
|
103 Minutes
n=107 Participants
|
105 Minutes
n=206 Participants
|
|
Type of surgery
Coronary Artery Bypass Graft (CABG)
|
109 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
226 Participants
n=206 Participants
|
|
Type of surgery
Coronary Aertery Bypass Graft, Aortic Valve Replacement (CABG/AVR)
|
35 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Type of surgery
Coronary Artery Bypass Graft, Mitral Valve Replacement CABG/MVR)
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Type of surgery
Coronary Artery Bypass Graft, Aortic Valve Replacement, Mitral Valve Replacement (CABG/AVR/MVR)
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Type of surgery
Aortic Valve Replacement (AVR)
|
41 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Type of surgery
Mitral Valve Replacement (MVR)
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Type of surgery
Aortic Valve Replacement, Mitral Valve Replacement (AVR/MVR)
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Type of surgery
Aortic Root Replacement
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Type of surgery
Coronary Artery Bypass Graft, (CABG) / Aortic Root Replacement
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Type of surgery
Transcatheter Aortic Valve Replacement (TAVR)
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Aortic cross-clamp (time in minutes)
|
73 Minutes
n=99 Participants
|
69 Minutes
n=107 Participants
|
71 Minutes
n=206 Participants
|
|
Duration of ICU admission (hours)
|
44.1 Hours
n=99 Participants
|
44 Hours
n=107 Participants
|
44 Hours
n=206 Participants
|
|
Duration of hospitalization (days)
|
8 Days
n=99 Participants
|
7 Days
n=107 Participants
|
7 Days
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeks post-operativePopulation: Subjects who completed neurological testing and MRI testing
The composite neurological outcome was composed of clinical stroke, or new ischemic lesions detected on postoperative brain diffusion weighted magnetic resonance imaging(DWI), or cognitive decline from baseline to 4-6 weeks after surgery.
Outcome measures
| Measure |
Usual Care Group (Control)
n=101 Participants
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=93 Participants
Blood pressure management based on cerebral autoregulation data.
blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
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 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Postoperative days 1-4Population: Delirium was measured day 1-4. 232 in the autoregulation group were assessed and 228 were assessed in the usual care group.
Assessed with Confusion Assessment Method or Confusion Assessment Method-ICU along with adjudication by team of experts
Outcome measures
| Measure |
Usual Care Group (Control)
n=228 Participants
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=232 Participants
Blood pressure management based on cerebral autoregulation data.
blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
Postoperative Delirium
|
34 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 7 days after surgeryPopulation: 228 in the usual care group and 232 in the autoregulation group were analyzed.
Use of multiple inotropic drugs greater than 24 hours after the planned surgical procedure until discharge from the hospital.
Outcome measures
| Measure |
Usual Care Group (Control)
n=228 Participants
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=232 Participants
Blood pressure management based on cerebral autoregulation data.
blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
Multiple Inotropic Drugs>24 Hours After Surgery
|
13 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Up to 28 days after surgery.Subjects need for mechanical lung ventilation more than 24 hours after planned surgical procedure.
Outcome measures
| Measure |
Usual Care Group (Control)
n=228 Participants
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=232 Participants
Blood pressure management based on cerebral autoregulation data.
blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
Mechanical Lung Ventilation>24 Hours After Surgery
|
22 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 7 days after surgeryProcedural insertion of intra-aortic balloon pump within 7 days after surgical procedure
Outcome measures
| Measure |
Usual Care Group (Control)
n=228 Participants
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=232 Participants
Blood pressure management based on cerebral autoregulation data.
blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
Insertion of Intra-aortic Balloon Pump
|
19 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days after surgery.Clinical diagnosis of postoperative atrial fibrillation from date of surgical procedure to discharge from the hospital.
Outcome measures
| Measure |
Usual Care Group (Control)
n=228 Participants
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=232 Participants
Blood pressure management based on cerebral autoregulation data.
blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
Postoperative Atrial Fibrillation
|
89 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days after surgery.Clinical diagnosis of sepsis from time of surgical procedure to discharge from the hospital.
Outcome measures
| Measure |
Usual Care Group (Control)
n=228 Participants
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=232 Participants
Blood pressure management based on cerebral autoregulation data.
blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
Sepsis
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 7 days after surgerySubject developed acute kidney injury within 7 days after surgical procedure. Based on Kidney disease: Improving Global Outcomes (KDIGO) classification system.
Outcome measures
| Measure |
Usual Care Group (Control)
n=228 Participants
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=232 Participants
Blood pressure management based on cerebral autoregulation data.
blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
Acute Kidney Injury Within 7 Days After Surgery.
|
56 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days after surgery.Subjects requiring new renal replacement therapy prior to discharge from hospital
Outcome measures
| Measure |
Usual Care Group (Control)
n=228 Participants
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=232 Participants
Blood pressure management based on cerebral autoregulation data.
blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
New Renal Replacement Therapy
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days after surgery.Subject diagnosis of multisystem organ failure after surgery.
Outcome measures
| Measure |
Usual Care Group (Control)
n=228 Participants
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=232 Participants
Blood pressure management based on cerebral autoregulation data.
blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
Multisystem Organ Failure After Surgery
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 28 daysSubject death within 28 days after surgical procedure
Outcome measures
| Measure |
Usual Care Group (Control)
n=228 Participants
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=232 Participants
Blood pressure management based on cerebral autoregulation data.
blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
Mortality
|
12 Participants
|
5 Participants
|
Adverse Events
Usual Care Group (Control)
Serious events: 133 serious events
Other events: 34 other events
Deaths: 12 deaths
Autoregulation Group
Serious events: 121 serious events
Other events: 19 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Usual Care Group (Control)
n=228 participants at risk
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=232 participants at risk
Blood pressure management based on cerebral autoregulation data.
Blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
24.6%
56/228 • Number of events 56 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
26.7%
62/232 • Number of events 62 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
|
General disorders
Multisystem Organ Failure after Surgery
|
2.6%
6/228 • Number of events 6 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
1.7%
4/232 • Number of events 4 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
|
Blood and lymphatic system disorders
Sepsis
|
3.1%
7/228 • Number of events 7 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
0.86%
2/232 • Number of events 2 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
|
Nervous system disorders
Clinical Stroke
|
3.9%
9/228 • Number of events 9 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
5.6%
13/232 • Number of events 13 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
|
Nervous system disorders
New Ischemic Lesions in Brian
|
55.3%
47/85 • Number of events 47 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
60.8%
48/79 • Number of events 48 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
|
General disorders
Delayed Neurocognitive Recovery
|
21.3%
35/164 • Number of events 35 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
15.7%
27/172 • Number of events 27 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
Other adverse events
| Measure |
Usual Care Group (Control)
n=228 participants at risk
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Control group: Institutional standard of care.
|
Autoregulation Group
n=232 participants at risk
Blood pressure management based on cerebral autoregulation data.
Blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
|
|---|---|---|
|
Psychiatric disorders
Clinically detected delirium
|
14.9%
34/228 • Number of events 34 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
8.2%
19/232 • Number of events 19 • Data were collected over a period of 1 year.
Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place