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Cerebral Monitoring for Cardiac Surgery Outcomes

N/A

Waitlist Available

Led By Kei Togashi, MD MPH

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult cardiac surgery patients undergoing cardio-pulmonary bypass (CPB) with cardioplegic arrest (CABG, valves, CABG + valves)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up blood samples taken1) at baseline following placement, 2) 30 min after initiation of bypass; 3) 10 min before separation from bypass; 4) 2 hours after separation from bypass and 5) before removal of the catheter or 12 hours after the end of surgery

Awards & highlights

Study Summary

This trial will compare patients who have a brain monitor to those who don't, in the hopes that the brain monitor will help decrease postoperative deficits and improve quality of life.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on monitoring methods rather than new medications or treatments directly administered to participants, specific side effects related to interventions aren't detailed here. However general risks associated with cardiac surgeries may still apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood samples taken1) at baseline following placement, 2) 30 min after initiation of bypass; 3) 10 min before separation from bypass; 4) 2 hours after separation from bypass and 5) before removal of the catheter or 12 hours after the end of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~blood samples taken1) at baseline following placement, 2) 30 min after initiation of bypass; 3) 10 min before separation from bypass; 4) 2 hours after separation from bypass and 5) before removal of the catheter or 12 hours after the end of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples taken1) at baseline following placement, 2) 30 min after initiation of bypass; 3) 10 min before separation from bypass; 4) 2 hours after separation from bypass and 5) before removal of the catheter or 12 hours after the end of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessing Change in Metabolomic Profile via Mass Spectrometry and NMR

Secondary outcome measures

Neurocognitive

Neurologic via CAM ICU and RASS Score During the Acute Post-Operative ICU Stay

Trial Design

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,740 Previous Clinical Trials

1,847,918 Total Patients Enrolled

Kei Togashi, MD MPHPrincipal InvestigatorUniversity of Washington

Media Library

Cerebral Monitor Guided Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03316183 — N/A

Cerebral Function Research Study Groups: Intervention Group, Control Group

Cerebral Function Clinical Trial 2023: Cerebral Monitor Guided Therapy Highlights & Side Effects. Trial Name: NCT03316183 — N/A

Cerebral Monitor Guided Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03316183 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase of this investigation still open?

"According to the details provided on clinicaltrials.gov, this particular medical study is not currently seeking participants. Initially posted on December 1st 2021 and last modified February 19th 2021; there are presently 60 other trials actively searching for patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cerebral Monitor Guided Therapy on Cerebral Outcomes After Cardiac Surgery

Kei Togashi 2021. "Cerebral Monitor Guided Therapy on Cerebral Outcomes After Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03316183.