Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction

Randomized Comparison Between Oxygenator Systems for the Reduction of Post-operative Delirium in Older Patients Undergoing Cardiac Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04062396

Acronym

CRIDD

Enrollment

154

Registered

2019-08-20

Start date

2019-09-26

Completion date

2023-01-23

Last updated

2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Cardiopulmonary Bypass

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.

Interventions

DEVICEEurosets 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

DEVICELivaNova INSPIRE oxygenator

INSPIRE oxygenator has no filtration system for extracavitary inlet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026