Cardiac SurgeryCRIDDNCT04062396
Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction
A study testing Eurosets REMOWELL 2 oxygenator and LivaNova INSPIRE oxygenator in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Maria Cecilia Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiac Surgery, Cardiopulmonary Bypass
- What is being tested?
- Eurosets REMOWELL 2 oxygenator and LivaNova INSPIRE oxygenator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteItaly
- Study dates
- 26 Sep 2019to 23 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Liver cirrhosis (platelets <100.000/uL)
- Decompensated diabetes
- Severe preoperative anemia (hemoglobin <8 g/dl).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass
- Being tested
- Eurosets REMOWELL 2 oxygenator, LivaNova INSPIRE oxygenator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eurosets REMOWELL 2 oxygenatorDevice
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 oxygenatorDevice
INSPIRE oxygenator has no filtration system for extracavitary inlet
| Study group | Role | What they receive |
|---|---|---|
| Eurosets REMOWELL 2 oxygenator | Active comparator | Not described Receives: Device: Eurosets REMOWELL 2 oxygenator |
| LivaNova INSPIRE oxygenator | Active comparator | Not described Receives: Device: LivaNova INSPIRE oxygenator |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative delirium
In-hospital incidence of post-operative delirium assessed by Confusion Assessment Method (CAM) diagnostic algorithm
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start26 Sep 2019
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Cecilia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Mantovani, MD, Principal investigator, Maria Cecilia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062396
- Sponsor's protocol ID
- MCH2019-01
- Acronym
- CRIDD
- Status last verified
- Jan 2024
- First submitted
- 19 Aug 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Between Oxygenator Systems for the Reduction of Post-operative Delirium in Older Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04062396
- Acronym / sponsor ID
- CRIDD / MCH2019-01
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Maria Cecilia HospitalUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eurosets REMOWELL 2 oxygenator | Active comparator | Device: Eurosets REMOWELL 2 oxygenator |
| LivaNova INSPIRE oxygenator | Active comparator | Device: LivaNova INSPIRE oxygenator |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Signature of informed consent for participation in the study
- Age ≥65 years
- Patients undergoing cardiac surgery of:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eurosets REMOWELL 2 oxygenatorThe 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 | Device | Eurosets REMOWELL 2 oxygenator |
| LivaNova INSPIRE oxygenatorINSPIRE oxygenator has no filtration system for extracavitary inlet | Device | LivaNova INSPIRE oxygenator |
Primary outcome
post-operative delirium
Time frame: 6 days
In-hospital incidence of post-operative delirium assessed by Confusion Assessment Method (CAM) diagnostic algorithm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Mantovani, MD principal investigator
Maria Cecilia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eurosets REMOWELL 2 oxygenator and LivaNova INSPIRE oxygenator in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Maria Cecilia Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative delirium (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.