Cognitive DysfunctionDNRNCT03636074
Effects of Hypothermia on Delayed Neurocognitive Recovery (DNR): an Observational Trial Among Patients Undergoing Cardiac-Surgery
An observational study of Cognitive Dysfunction and Emergence Delirium, run by University of Padova at 1 site in Italy.
Trial summary
Post-operative cognitive dysfunction is a common disease in patient undergoing general anaesthesia, especially in older patients. No correlations have been yet studied between intraoperative hypothermia and incidence of Delayed Neurocognitive Recovery. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction, Emergence Delirium, Hypothermia
- What is being tested?
- Hypothermia during Extracorporeal Circulation
- Type of treatment
- Surgery or procedure
- How many people
- 168 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2020to 12 Jun 2023
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prospective Observational Case-Control
Who may be able to join
- Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation
Who cannot join
- Neurological disease before surgery
- Sedation in Cardiac-Surgery Intensive Unit > 6 hours
- Cerebral regional Oxygen saturation <20% baseline during surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hypothermia on Delayed Neurocognitive Recovery: an Observational Trial Among Patients Undergoing Cardiac-Surgery
Post-operative cognitive dysfunction is a common disease in patient undergoing general anaesthesia, especially in older patients. No correlations have been yet studied between intraoperative hypothermia and incidence of Delayed Neurocognitive Recovery. Investigators are going to estimate the Relative Risk of Hypothermia and emergence of Post-operative cognitive dysfunction in cardiac-surgery patients.
- Conditions
- Cognitive Dysfunction, Emergence Delirium, Hypothermia
- Being tested
- Hypothermia during Extracorporeal Circulation
- Medical subject headings
- Cognitive Dysfunction, Emergence Delirium, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothermia during Extracorporeal CirculationProcedure or surgery
Normothermia during Extracorporeal Circulation
| Study group | Role | What they receive |
|---|---|---|
| Hearth-valve surgery | Not described Receives: Procedure: Hypothermia during Extracorporeal Circulation | |
| Hearth bypass surgery | Not described Receives: Procedure: Hypothermia during Extracorporeal Circulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery
Discover changes between pre-operative general cognition tests (Montreal Cognitive Assessment and Short Portable Mental Status Questionnaire) test score and post-operative Montreal Cognitive Assessment test score.
Measured: Patients will be subjected to Montreal Cognitive Assessment and Short Portable Mental Status Questionnaire test one day before surgery and 4-6 days after surgery
Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery
Discover changes between pre-operative Trail Making Test A and B score and post-operative Trail Making Test A and B score.
Measured: Patients will be subjected to Trail Making Test A and B one day before surgery and 4-6 days after surgery
Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery
Discover changes between pre-operative Digit Span Test score and post-operative Digit Span Test score.
Measured: Patients will be subjected to Digit Span Test one day before surgery and 4-6 days after surgery
Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery
Discover changes between pre-operative Frontal Assessment Battery test score and post-operative Frontal Assessment Battery test score and
Measured: Patients will be subjected to Frontal Assessment Battery test one day before surgery and 4-6 days after surgery
Secondary outcomes (1)
Effects of hypothermia during Extracorporeal Circulation in Cardiac Surgery
Discover statistical significance difference in incidence of Post-Operative Cognitive Decline between patients undergoing normothermia and patients undergoing hypothermia during Extracorporeal Circulation in Cardiac Surgery
Measured: One day before surgery and 4-6 days after surgery patients will be subjected to cognitive test to diagnosticate Post-Operative Cognitive Decline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start7 Jan 2020
- Primary completion30 May 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Linassi, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636074
- Sponsor's protocol ID
- Zivago
- Acronym
- DNR
- Status last verified
- Nov 2023
- First submitted
- 7 Aug 2018
- Last updated
- 9 Nov 2023
- Results posted
- No
- 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hypothermia on Delayed Neurocognitive Recovery: an Observational Trial Among Patients Undergoing Cardiac-Surgery
- ClinicalTrials.gov ID
- NCT03636074
- Acronym / sponsor ID
- DNR / Zivago
- Conditions
- Cognitive Dysfunction, Emergence Delirium, Hypothermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 17 Aug 2018 (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.
Post-operative cognitive dysfunction is a common disease in patient undergoing general anaesthesia, especially in older patients. No correlations have been yet studied between intraoperative hypothermia and incidence of Delayed Neurocognitive Recovery. Investigators are going to estimate the Relative Risk of Hypothermia and emergence of Post-operative cognitive dysfunction in cardiac-surgery patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearth-valve surgery | – | Procedure: Hypothermia during Extracorporeal Circulation |
| Hearth bypass surgery | – | Procedure: Hypothermia during Extracorporeal Circulation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective Observational Case-Control
Key inclusion criteria (1 listed)
- Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation
Key exclusion criteria (3 listed)
- Neurological disease before surgery
- Sedation in Cardiac-Surgery Intensive Unit > 6 hours
- Cerebral regional Oxygen saturation <20% baseline during surgery
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 |
|---|---|---|
| Hypothermia during Extracorporeal CirculationNormothermia during Extracorporeal Circulation | Procedure or surgery | Hearth bypass surgery, Hearth-valve surgery |
Primary outcome
Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery
Time frame: Patients will be subjected to Montreal Cognitive Assessment and Short Portable Mental Status Questionnaire test one day before surgery and 4-6 days after surgery
Discover changes between pre-operative general cognition tests (Montreal Cognitive Assessment and Short Portable Mental Status Questionnaire) test score and post-operative Montreal Cognitive Assessment test score.
Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery
Time frame: Patients will be subjected to Trail Making Test A and B one day before surgery and 4-6 days after surgery
Discover changes between pre-operative Trail Making Test A and B score and post-operative Trail Making Test A and B score.
Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery
Time frame: Patients will be subjected to Digit Span Test one day before surgery and 4-6 days after surgery
Discover changes between pre-operative Digit Span Test score and post-operative Digit Span Test score.
Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery
Time frame: Patients will be subjected to Frontal Assessment Battery test one day before surgery and 4-6 days after surgery
Discover changes between pre-operative Frontal Assessment Battery test score and post-operative Frontal Assessment Battery test score and
1 secondary outcome
Effects of hypothermia during Extracorporeal Circulation in Cardiac Surgery
Time frame: One day before surgery and 4-6 days after surgery patients will be subjected to cognitive test to diagnosticate Post-Operative Cognitive Decline
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 9 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction and Emergence Delirium, run by University of Padova 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 1 inclusion and 3 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 9 Nov 2023. 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?
Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery (time frame: Patients will be subjected to Montreal Cognitive Assessment and Short Portable Mental Status Questionnaire test one day before surgery and 4-6 days after surgery). The study lists 4 primary outcomes in all. 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 9 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.