A Multicenter, Randomized, Controlled Clinical Trial of Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Neurological dysfunction continues to be one of the complications of considerable concern in patients undergoing cardiac surgery. It was previously reported in the literature, that cerebral oxygen desaturation during cardiac surgery was associated with an increased incidence of cognitive impairment. This study aims to determine whether continuous monitoring of cerebral oximetry improves the neurocognitive outcome in coronary artery bypass surgery when associated with predetermined intervention protocol to optimize cerebral oxygenation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Age 60 or older

• Elective coronary artery bypass graft surgery using cardiopulmonary bypass

• Preoperative cognitive assessment by means of Mini-Mental State Examination (MMSE) test, greater than or equal to 24

• Signed informed consent

Locations
Other Locations
Brazil
Hospital São José
RECRUITING
Criciúma
Instituto Nacional de Cardiologia
RECRUITING
Rio De Janeiro
Contact Information
Primary
Carlos Galhardo, MD
cgalhardo@uol.com.br
+55(21)999115844
Time Frame
Start Date: 2021-05-19
Estimated Completion Date: 2024-07-20
Participants
Target number of participants: 326
Treatments
Active_comparator: Cerebral Oxymetry Monitoring
The following procedures should be performed sequentially in the event of cerebral desaturation after 30 seconds:~1. The positioning of the head, the presence of facial plethora, and bad position of catheters should be corrected;~2. In case of arterial hypotension, the causal factors should be assessed and treated;~3. In the presence of arterial hypoxemia, the causal factors should be assessed and treated to maintain a PaO2 \> 150 mmHg;~4. In the presence of hypercapnia, adjust the ventilation parameters avoiding hyperventilation;~5. In the presence of anemia, the causal factors should be assessed, and the decision to undergo transfusion should also take into consideration the presence of tissue hypoperfusion;~6. In cases of SvO2 below 70% and signs of hemodynamic instability, optimize fluid replacement and ventricular global contractility;~7. Assess the increase of brain consumption of O2, avoiding the superficial level of anesthesia, hyperthermia, and tremors.
No_intervention: Control Group
Patients will be treated according to the attending anesthesiologist, without the monitoring of cerebral oximetry, but to maintain a heart rate between 70 - 100 bpm, lactate levels \<3 mmol/L and urine output\> 0.5mL/Kg/h. In case of arterial hypotension the causal factors should be assessed and treated; in case of SvO2 below 70% and signs of hemodynamic instability, optimize volume replacement and global ventricular contractility through inotropic agents (epinephrine, dobutamine or milrinone); in the presence of anemia (Hb \<6 to 7g/dL during CPB or Hb \<8g/dL in the pre-CPB or post-CPB period), the causal factors should be assessed and the decision to transfuse should also take into account the presence of hypoperfusion tissue (increased lactate, low SvO2, acidosis); in episodes of bradycardia with hemodynamic instability, atropine may be used.
Related Therapeutic Areas
Sponsors
Leads: Instituto Nacional de Cardiologia de Laranjeiras

This content was sourced from clinicaltrials.gov