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Assessment of Postoperative Delirium With CAM ICU Score in Patients Treated With Serotoninergic Reuptake (SSRI) Inhibitors and Undergoing Intervention of Heart Surgery on Pump

Assessment of Postoperative Delirium With CAM ICU Score in Patients Treated With Serotoninergic Reuptake (SSRI) Inhibitors and Undergoing Intervention of Heart Surgery on Pump

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05089097
Acronym
DeCAMS-ON
Enrollment
152
Registered
2021-10-22
Start date
2020-06-04
Completion date
2021-09-15
Last updated
2021-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

Delirium, Postoperative, CAM-ICU Score

Brief 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.

Interventions

OTHERevaluation of delirium with CAM-ICU Score

the CAM-ICU score is an evaluation tool to verify the presence or absence of delirium in a subject

Sponsors

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inhibitors of serotoninergic reuptake on Inclusion Criteria: * 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

Exclusion criteria

* 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) Inhibitors of serotoninergic reuptake off Inclusion Criteria: * 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

Design outcomes

Primary

MeasureTime frameDescription
Presence/absence of postoperative delirium4 june 2020 to 4 june 2021presence / absence of postoperative delirium, assessed with CAM-ICU, from awakening and for the following 48 hours

Secondary

MeasureTime frameDescription
correlation with Hospital-Length of Stay4 june 2020 to 4 june 2021correlation with Hospital-Length of Stay
Bleeding4 june 2020 to 4 june 2021measure of bleeding in ml / day
re-operated patient4 june 2020 to 4 june 2021Number of re-operated patient
Correlation with ICU-Length of Stay4 june 2020 to 4 june 2021Correlation with ICU-Length of Stay
mortality4 june 2020 to 4 june 2021mortality at 28 days
infections4 june 2020 to 4 june 2021number and type of infections that occurred following the operation
mechanical ventilation in intensive care4 june 2020 to 4 june 2021number of patients who required mechanical ventilation in the ICU

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026