Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction

Not Applicable

Completed

• Conditions: Cardiopulmonary Bypass; Cardiac Surgery
• Interventions: Device: LivaNova INSPIRE oxygenator; Device: Eurosets REMOWELL 2 oxygenator

• Registration Number: NCT04062396
• Lead Sponsor: Maria Cecilia Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Study Start: 2019-09-26
• Primary Completion: 2023-01-23
• Study Completion: 2023-01-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1. Signature of informed consent for participation in the study

2. Age ≥65 years

3. Patients undergoing cardiac surgery of:

   1. coronary artery bypass graft and concomitant valve replacement/repair OR
   2. double valve replacement/repair

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LivaNova INSPIRE oxygenator	LivaNova INSPIRE oxygenator	-
Eurosets REMOWELL 2 oxygenator	Eurosets REMOWELL 2 oxygenator	-

Primary Outcome Measures

Name	Time	Method
post-operative delirium	6 days	In-hospital incidence of post-operative delirium assessed by Confusion Assessment Method (CAM) diagnostic algorithm

Trial Locations

Locations (1)

Maria Cecilia Hospital; 🇮🇹 Cotignola, Ravenna, Italy