Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction

Cardiac Surgery Clinical Trial

— CRIDD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062396
• Other study ID #: MCH2019-01
• Status: Completed
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: January 23, 2023

Study information

• Verified date: January 2024
• Source: Maria Cecilia Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass
• Delirium

Intervention

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
• LivaNova INSPIRE oxygenator
INSPIRE oxygenator has no filtration system for extracavitary inlet

Locations

Country	Name	City	State
Italy	Maria Cecilia Hospital	Cotignola	Ravenna

Sponsors (1)

Lead Sponsor	Collaborator
Maria Cecilia Hospital

Country where clinical trial is conducted

Italy, 

Outcome

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