Cerebral Monitor Guided Therapy on Cerebral Outcomes After Cardiac Surgery

NCT03316183 | Unknown

• 1 other identifier: STUDY00002376
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Surgery; Protein Metabolomics; Cerebral Function; Cardiopulmonary Bypass

Keywords

cerebral oximetry; near-infrared spectroscopy (NIRS); metabolomic profiling; neurocognitive outcomes; Cerebral protection

Outcome Measures

Primary Outcomes (1)

• Assessing Change in Metabolomic Profile via Mass Spectrometry and NMR

  Blood samples will be tested for potential organ-specific biomarker to diagnose and classify cerebral protein consumption to assess neurological activity.

  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

Secondary Outcomes (2)

• Neurocognitive

  baseline, 6 weeks post-operation

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

  To be gathered as a part of routine critical care assessment throughout the participant's ICU stay. Up to 2 weeks post surgery

Study Arms (2)

Intervention Group

EXPERIMENTAL

* 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.

Other: Perioperative and postoperative management

Control Group

NO 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.

Interventions

Perioperative and postoperative management OTHER

Cerebral oximetry informed perioperative management

Intervention Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• History of a stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (\> 80%) extra cranial stenosis;
• Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator;
• Existence of any ongoing mechanical circulatory support other than intra- aortic balloon counter pulsation;
• Body Mass Index (BMI) \> 50 kg/m2;
• Pregnancy;
• Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol;
• Presence of active, uncontrolled infection;
• Evidence of intrinsic hepatic disease as defined by liver enzyme values;
• Participation in any other clinical investigation that is likely to confound study results or affect study outcome;
• Patient refuses to be enrolled in study;
• Institution inmates

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Study Officials

• Kei Togashi, MD MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kei Togashi, MD MPH

CONTACT

2065981994; ktogashi@uw.edu

G. Burkhard Mackensen, MD PhD FASE

CONTACT

2065981462; gbmac@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine, Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: October 20, 2017
• Study Start: December 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)