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

Delirium Clinical Trial

— DeCAMS-ON  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05089097
• Other study ID #: ASO.Cch.19.01
• Status: Completed
• Start date: June 4, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: October 2021
• Source: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 15, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Delirium

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo	Alessandria

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of postoperative delirium	presence / absence of postoperative delirium, assessed with CAM-ICU, from awakening and for the following 48 hours	4 june 2020 to 4 june 2021
Secondary	Correlation with ICU-Length of Stay	Correlation with ICU-Length of Stay	4 june 2020 to 4 june 2021
Secondary	correlation with Hospital-Length of Stay	correlation with Hospital-Length of Stay	4 june 2020 to 4 june 2021
Secondary	Bleeding	measure of bleeding in ml / day	4 june 2020 to 4 june 2021
Secondary	re-operated patient	Number of re-operated patient	4 june 2020 to 4 june 2021
Secondary	mechanical ventilation in intensive care	number of patients who required mechanical ventilation in the ICU	4 june 2020 to 4 june 2021
Secondary	mortality	mortality at 28 days	4 june 2020 to 4 june 2021
Secondary	infections	number and type of infections that occurred following the operation	4 june 2020 to 4 june 2021