Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction (CRIDD)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Cardiopulmonary Bypass
• Intervention / Treatment: Device: Eurosets REMOWELL 2 oxygenator; Device: LivaNova INSPIRE oxygenator

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo Cimaglia, MD; Phone Number: +39 0545217031; Email: pcimaglia@gvmnet.it

Study Locations

• Italy
  • Ravenna
    • Cotignola, Ravenna, Italy, 48010
      • Maria Cecilia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Eurosets REMOWELL 2 oxygenator	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
Active Comparator: LivaNova INSPIRE oxygenator	Device: LivaNova INSPIRE oxygenator; INSPIRE oxygenator has no filtration system for extracavitary inlet

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Maria Cecilia Hospital
• Investigators: Principal Investigator: Lorenzo Mantovani, MD, Maria Cecilia Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): January 23, 2023
• Study Completion (Actual): January 23, 2023

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: MCH2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No