Clinical trial NCT05089097: Assessment of Postoperative Delirium With CAM ICU Score in Patients Treated With Serotoninergic Reuptake (SSRI) Inhibitors and Undergoing Intervention of Heart Surgery on Pump
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Delirium
Postoperative
CAM-ICU Score
Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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.


Eligibility 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

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)

Primary outcomes:
measure: Presence/absence of postoperative delirium
timeFrame: 4 june 2020 to 4 june 2021
Secondary outcomes:
measure: Correlation with ICU-Length of Stay
timeFrame: 4 june 2020 to 4 june 2021
measure: correlation with Hospital-Length of Stay
timeFrame: 4 june 2020 to 4 june 2021
measure: Bleeding
timeFrame: 4 june 2020 to 4 june 2021
measure: re-operated patient
timeFrame: 4 june 2020 to 4 june 2021
measure: mechanical ventilation in intensive care
timeFrame: 4 june 2020 to 4 june 2021
measure: mortality
timeFrame: 4 june 2020 to 4 june 2021
measure: infections
timeFrame: 4 june 2020 to 4 june 2021
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
Study officials:
References: