DeCAMS-ON: 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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: evaluation 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
|
| 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. |
Other: evaluation 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
|
Outcome Measures
Primary Outcome Measures
- Presence/absence of postoperative delirium [4 june 2020 to 4 june 2021]
presence / absence of postoperative delirium, assessed with CAM-ICU, from awakening and for the following 48 hours
Secondary Outcome Measures
- Correlation with ICU-Length of Stay [4 june 2020 to 4 june 2021]
Correlation with ICU-Length of Stay
- correlation with Hospital-Length of Stay [4 june 2020 to 4 june 2021]
correlation with Hospital-Length of Stay
- Bleeding [4 june 2020 to 4 june 2021]
measure of bleeding in ml / day
- re-operated patient [4 june 2020 to 4 june 2021]
Number of re-operated patient
- mechanical ventilation in intensive care [4 june 2020 to 4 june 2021]
number of patients who required mechanical ventilation in the ICU
- mortality [4 june 2020 to 4 june 2021]
mortality at 28 days
- infections [4 june 2020 to 4 june 2021]
number and type of infections that occurred following the operation
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo | Alessandria | Italy | 15121 |
Sponsors and Collaborators
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ASO.Cch.19.01