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Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction

NCT04062396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-02-20

No results posted yet for this study

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.

Conditions

  • Cardiac Surgery
  • Cardiopulmonary Bypass

Interventions

DEVICE

Eurosets REMOWELL 2 oxygenator

The main characteristic of REMOWELL 2 oxygenator is the presence of a filtration system for extracavitary inlet. Multilayer cascade filtration and supernatant separator leads to lipid-leukocytes depletion

DEVICE

LivaNova INSPIRE oxygenator

INSPIRE oxygenator has no filtration system for extracavitary inlet

Sponsors & Collaborators

  • Maria Cecilia Hospital

    lead OTHER

Principal Investigators

  • Lorenzo Mantovani, MD · Maria Cecilia Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2023-01-23
Completion
2023-01-23

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04062396 on ClinicalTrials.gov