DeliriumDeCAMS-ONNCT05089097
Assessment of Postoperative Delirium With CAM ICU Score in Patients Treated With Serotoninergic Reuptake (SSRI) Inhibitors and Undergoing Intervention of Heart Surgery on Pump
An observational study of Delirium, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
The study aims to observe the presence of postoperative delirium in patients undergoing elective cardiac surgery, without changing the pharmacological prescriptions of the enrolled patients and the procedures carried out by normal clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- evaluation of delirium with CAM-ICU Score
- How many people
- 152 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jun 2020to 15 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients over 18 years of age, of both sexes, undergoing elective cardiac surgery and with the presence or absence of depressive pathology in therapy with Inhibitors of serotoninergic reuptake
Who may be able to join
- patients over 18 years old
- patients undergoing elective cardiac surgery
- patients diagnosed with depressive syndrome requiring treatment with Inhibitors of serotoninergic reuptake excluding neurodegenerative diseases
- patients on antidepressant therapy for more than 3 months at the time of enrollment
- patients over 18 years old
- patients undergoing elective cardiac surgery
- patients without a diagnosis of depressive and psychiatric illness requiring treatment with psychoactive drugs to the exclusion of neurodegenerative diseases
Who cannot join
- absence of written informed consent to the study
- patients undergoing non-elective and emergency cardiac surgery
- patients undergoing off pump surgery
- patients with depression not on therapy
- patients with existing malignancies
- patients with acute infections in progress
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- patients with previous stroke, cerebral haemorrhage with relics
- patients with acquired and congenital metabolic pathologies with CNS alterations
- Patients with acute and / or chronic renal failure according to RIFLE score (exclude only F-L-E)
- Patients with acute and / or chronic hepatic insufficiency according to Child - Pugh score <6 (but without encephalopathy);
- Patients with neurodegenerative diseases (dementias of all types both organic and vascular, parkinson's and ongoing delirium);
- Patients with previous or current drug and / or alcohol abuse
- pregnant or postpartum period patients (6 months after delivery)
- Inhibitors of serotoninergic reuptake off
- absence of written informed consent to the study
- patients undergoing non-elective and emergency cardiac surgery
- patients undergoing off pump surgery
- patients with depression not on therapy
- patients with existing malignancies
- patients with acute infections in progress
- patients with previous stroke, cerebral haemorrhage with relics
- patients with acquired and congenital metabolic pathologies with CNS alterations
- Patients with acute and / or chronic renal failure according to RIFLE score (exclude only F-L-E)
- Patients with acute and / or chronic hepatic insufficiency according to Child - Pugh score <6 (but without encephalopathy);
- Patients with neurodegenerative diseases (dementias of all types both organic and vascular, parkinson's and ongoing delirium);
- Patients with previous or current drug and / or alcohol abuse
- pregnant or postpartum period patients (6 months after delivery)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
About this study
The study aims to observe the presence of postoperative delirium in patients undergoing elective cardiac surgery, without changing the pharmacological prescriptions of the enrolled patients and the procedures carried out by normal clinical practice.
- Conditions
- Delirium
- Being tested
- evaluation of delirium with CAM-ICU Score
- Keywords
- Delirium, Postoperative, CAM-ICU Score
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of delirium with CAM-ICU ScoreOther
the CAM-ICU score is an evaluation tool to verify the presence or absence of delirium in a subject
| Study group | Role | What they receive |
|---|---|---|
| Inhibitors of serotoninergic reuptake on | patients with a diagnosis of depressive syndrome requiring treatment with Inhibitors of serotoninergic reuptake drugs excluding neurodegenerative diseases and on treatment with antidepressants for more than three months.
Intervention: evaluation of the presence of postoperative delirium with the CAM-ICU score upon awakening and for the following 48 hours. Receives: Other: evaluation of delirium with CAM-ICU Score | |
| Inhibitors of serotoninergic reuptake off | patients without a diagnosis of depressive syndrome requiring treatment with Inhibitors of serotoninergic reuptake drugs excluding neurodegenerative diseases and not in treatment with antidepressants.
Intervention: evaluation of the presence of postoperative delirium with the CAM-ICU score upon awakening and for the following 48 hours. Receives: Other: evaluation of delirium with CAM-ICU Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of postoperative delirium
presence / absence of postoperative delirium, assessed with CAM-ICU, from awakening and for the following 48 hours
Measured: 4 june 2020 to 4 june 2021
Secondary outcomes (7)
Correlation with ICU-Length of Stay
Correlation with ICU-Length of Stay
Measured: 4 june 2020 to 4 june 2021
correlation with Hospital-Length of Stay
correlation with Hospital-Length of Stay
Measured: 4 june 2020 to 4 june 2021
Bleeding
measure of bleeding in ml / day
Measured: 4 june 2020 to 4 june 2021
re-operated patient
Number of re-operated patient
Measured: 4 june 2020 to 4 june 2021
mechanical ventilation in intensive care
number of patients who required mechanical ventilation in the ICU
Measured: 4 june 2020 to 4 june 2021
mortality
mortality at 28 days
Measured: 4 june 2020 to 4 june 2021
infections
number and type of infections that occurred following the operation
Measured: 4 june 2020 to 4 june 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start4 Jun 2020
- Primary completion4 Jun 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089097
- Sponsor's protocol ID
- ASO.Cch.19.01
- Acronym
- DeCAMS-ON
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Delirium With CAM ICU Score in Patients Treated With Serotoninergic Reuptake (SSRI) Inhibitors and Undergoing Intervention of Heart Surgery on Pump
- ClinicalTrials.gov ID
- NCT05089097
- Acronym / sponsor ID
- DeCAMS-ON / ASO.Cch.19.01
- Conditions
- Delirium
- Keywords
- Delirium, Postoperative, CAM-ICU Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 22 Oct 2021 (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.
The study aims to observe the presence of postoperative delirium in patients undergoing elective cardiac surgery, without changing the pharmacological prescriptions of the enrolled patients and the procedures carried out by normal clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhibitors of serotoninergic reuptake on | – | Other: evaluation of delirium with CAM-ICU Scorepatients with a diagnosis of depressive syndrome requiring treatment with Inhibitors of serotoninergic reuptake drugs excluding neurodegenerative diseases and on treatment with antidepressants for more than three months. Intervention: evaluation of the presence of postoperative delirium with the CAM-ICU score upon awakening and for the following 48 hours. |
| Inhibitors of serotoninergic reuptake off | – | Other: evaluation of delirium with CAM-ICU Scorepatients without a diagnosis of depressive syndrome requiring treatment with Inhibitors of serotoninergic reuptake drugs excluding neurodegenerative diseases and not in treatment with antidepressants. Intervention: evaluation of the presence of postoperative delirium with the CAM-ICU score upon awakening and for the following 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients over 18 years of age, of both sexes, undergoing elective cardiac surgery and with the presence or absence of depressive pathology in therapy with Inhibitors of serotoninergic reuptake
Key inclusion criteria (7 listed)
- patients over 18 years old
- patients undergoing elective cardiac surgery
- patients diagnosed with depressive syndrome requiring treatment with Inhibitors of serotoninergic reuptake excluding neurodegenerative diseases
- patients on antidepressant therapy for more than 3 months at the time of enrollment
- patients over 18 years old
Key exclusion criteria (27 listed)
- absence of written informed consent to the study
- patients undergoing non-elective and emergency cardiac surgery
- patients undergoing off pump surgery
- patients with depression not on therapy
- patients with existing malignancies
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 |
|---|---|---|
| evaluation of delirium with CAM-ICU Scorethe CAM-ICU score is an evaluation tool to verify the presence or absence of delirium in a subject | Other | Inhibitors of serotoninergic reuptake off, Inhibitors of serotoninergic reuptake on |
Primary outcome
Presence/absence of postoperative delirium
Time frame: 4 june 2020 to 4 june 2021
presence / absence of postoperative delirium, assessed with CAM-ICU, from awakening and for the following 48 hours
7 secondary outcomes
Correlation with ICU-Length of Stay
Time frame: 4 june 2020 to 4 june 2021
correlation with Hospital-Length of Stay
Time frame: 4 june 2020 to 4 june 2021
Bleeding
Time frame: 4 june 2020 to 4 june 2021
re-operated patient
Time frame: 4 june 2020 to 4 june 2021
mechanical ventilation in intensive care
Time frame: 4 june 2020 to 4 june 2021
mortality
Time frame: 4 june 2020 to 4 june 2021
infections
Time frame: 4 june 2020 to 4 june 2021
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 22 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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 Delirium, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria 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 7 inclusion and 27 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 22 Oct 2021. 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?
Presence/absence of postoperative delirium (time frame: 4 june 2020 to 4 june 2021). 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 22 Oct 2021.