Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction

NCT04062396 | Completed DMC

• 1 other identifier: MCH2019-01
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• post-operative delirium

  In-hospital incidence of post-operative delirium assessed by Confusion Assessment Method (CAM) diagnostic algorithm

  6 days

Study Arms (2)

Eurosets REMOWELL 2 oxygenator

ACTIVE COMPARATOR

Device: Eurosets REMOWELL 2 oxygenator

LivaNova INSPIRE oxygenator

ACTIVE COMPARATOR

Device: LivaNova INSPIRE oxygenator

Interventions

Eurosets REMOWELL 2 oxygenator DEVICE

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

Eurosets REMOWELL 2 oxygenator

LivaNova INSPIRE oxygenator DEVICE

INSPIRE oxygenator has no filtration system for extracavitary inlet

LivaNova INSPIRE oxygenator

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maria Cecilia Hospital: lead

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48010, Italy

Location

Study Officials

• Lorenzo Mantovani, MD

  Maria Cecilia Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 20, 2019
• Study Start: September 26, 2019
• Primary Completion: January 23, 2023
• Study Completion: January 23, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-01

Locations

IT (1)