Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction

  • STATUS
    Recruiting
  • End date
    Mar 23, 2022
  • participants needed
    314
  • sponsor
    Maria Cecilia Hospital
Updated on 23 January 2021

Summary

Age is no longer an absolute contraindication to cardiac surgery therefore there is often need for combined interventions (double valve repair/replacement, or coronary artery bypass graft and valve repair/replacement) with relative prolongation of cardiopulmonary bypass time. Prolonged cardiopulmonary bypass use causes an increase in the inflammatory response, and on the other a need for blood reinfusion and therefore lipid microemboli from the operative field. The clinical consequences for patients are post-operative delirium and post-operative cognitive impairment.

These two neurological complications involve up to 45% of elderly patients undergoing cardiac surgery and have a significant impact on quality of life, hospitalization and mortality in the short and long term. The Remowell 2 oxygenator system has demonstrated in preliminary studies that, compared to the gold standard Inspire oxygenator, it can guarantee a significant reduction of hemodilution, inflammatory systemic response and embolization of lipid microemboli and leukocytes. In light of these considerations, it is possible to formulate the hypothesis that the use of the Remowell 2 device can contribute to significantly reducing the onset of post-operative delirium and cognitive impairment. The present study is designed to validate this hypothesis in a randomized controlled scenario.

Details
Condition Thoracic Surgery, heart surgery, Cardiopulmonary Bypass, Cardiac Surgery, heart/lung bypass, cardiac operation
Treatment Eurosets REMOWELL 2 oxygenator, LivaNova INSPIRE oxygenator
Clinical Study IdentifierNCT04062396
SponsorMaria Cecilia Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 65 yrs?
Gender: Male or Female
Do you have any of these conditions: heart surgery or Thoracic Surgery or heart/lung bypass or cardiac operation or Cardiopulmonary Bypass or Cardiac Surgery?
Signature of informed consent for participation in the study
Age 65 years
Patients undergoing cardiac surgery of
coronary artery bypass graft and concomitant valve replacement/repair OR
double valve replacement/repair

Exclusion Criteria

Any documented history of cognitive impairment estimated as a mini mental state examination < 24 points
Patients who need blood prime in the cardiopulmonary bypass circuit
Chronic coagulopathies ( international normalized ratio > 2 in patients without anticoagulant treatment)
End stage renal disease on dialysis treatment
Previous cerebrovascular accident
Active cancer or immunological diseases
Liver cirrhosis (platelets <100.000/uL)
Decompensated diabetes
Severe preoperative anemia (hemoglobin <8 g/dl)
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