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Compensation: Varies

Number of Visits: 6

Duration: Surgery and immediate post-operative period (up to 24 hours post-surgery)

20 Participants Needed

Cerebral Monitoring for Cardiac Surgery Outcomes

Overseen ByG. Burkhard Mackensen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Stroke, Cerebral vascular disease, Pregnancy, Infection, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare patients' metabolomic profiles who are managed with a brain monitor that measures cerebral oxygen to those who are managed by conventional measures to hopefully decrease postoperative neurologic and cognitive deficits and improve quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Cerebral Monitor Guided Therapy for cardiac surgery outcomes?

The Cerebral Function Monitor, used in Cerebral Monitor Guided Therapy, helps detect early brain damage during heart surgery, which can improve patient outcomes by allowing timely interventions. Continuous brain monitoring during cardiac surgery has been shown to help prevent brain injuries, which are common and serious complications in these procedures.¹ ² ³ ⁴ ⁵

Is cerebral monitoring during cardiac surgery safe for humans?

Cerebral monitoring during cardiac surgery is generally considered safe and is used to help prevent brain injuries by detecting potential issues early. It involves techniques like monitoring brain blood flow and oxygen levels, which can improve patient outcomes and reduce complications.¹ ² ³ ⁶ ⁷

How does Cerebral Monitor Guided Therapy differ from other treatments for brain injury after cardiac surgery?

Cerebral Monitor Guided Therapy is unique because it uses continuous monitoring of brain activity to guide treatment during cardiac surgery, aiming to prevent brain injury by detecting issues early. This approach is different from traditional methods that may not use real-time brain monitoring to adjust treatment.¹ ² ³ ⁴ ⁵

Research Team

Kei Togashi, MD MPH

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for adult cardiac surgery patients who will undergo procedures involving cardiopulmonary bypass and heart arrest, like bypasses or valve replacements. It's not for those with recent strokes, severe artery narrowing in the brain, extremely high surgical risk as judged by doctors, a BMI over 50, pregnancy, certain psychiatric conditions or cognitive issues that affect study compliance, uncontrolled infections, liver disease indicated by enzyme tests, participation in other conflicting studies or refusal to enroll.

Inclusion Criteria

I am an adult scheduled for heart surgery involving a heart-lung machine and stopping my heart.

Exclusion Criteria

Institution inmates

Participation in any other clinical investigation that is likely to confound study results or affect study outcome

Pregnancy

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac surgery with cerebral oximetry monitoring and metabolomic profiling

Surgery and immediate post-operative period (up to 24 hours post-surgery)

In-hospital stay for surgery and monitoring

Follow-up

Participants are monitored for neurocognitive outcomes and metabolomic changes

6 weeks

Follow-up visits at discharge and 6 weeks post-operation

Post-operative ICU Stay

Neurologic clinical testing during the acute post-operative ICU stay

Up to 2 weeks post-surgery

Treatment Details

Interventions

Cerebral Monitor Guided Therapy

Trial Overview The study aims to see if using a cerebral oxygen monitor during and after heart surgery can improve brain function outcomes compared to standard care. Researchers will compare metabolomic profiles (which are like chemical fingerprints of metabolism) between the two groups to assess the impact on neurological health and quality of life post-surgery.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

* Maintain rSO2 values at or above 75% of the baseline * Midline position * Target CO2 of ≥40 mmHg, target MAP \>60 mm Hg * Maintain cerebral perfusion pressure \>50 mm Hg * Target pump flow 2.5 L/m2/min * If rSO2 persistently below treatment threshold: * FiO2 is increased * or propofol 50-100 mg bolus is administered * If Hct below 20% packed red blood cells will be transfused timeline: before induction, after time-out has been performed, and will continue until 24 hours post surgery.

Group II: Control GroupActive Control1 Intervention

Patients in the control group will be managed under the attending physician's discretion. Cerebral oximetry data will be collected in the same fashion as in the intervention group, but the measurements will be blinded to the physician. Blood samples will be collected for metabolomic profiling in the same fashion and at identical time points as the intervention group for later analysis.