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

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 Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Other: evaluation of delirium with CAM-ICU Score

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• Italy
  • Alessandria, Italy, 15121
    • Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with ICU-Length of Stay	Correlation with ICU-Length of Stay	4 june 2020 to 4 june 2021
correlation with Hospital-Length of Stay	correlation with Hospital-Length of Stay	4 june 2020 to 4 june 2021
Bleeding	measure of bleeding in ml / day	4 june 2020 to 4 june 2021
re-operated patient	Number of re-operated patient	4 june 2020 to 4 june 2021
mechanical ventilation in intensive care	number of patients who required mechanical ventilation in the ICU	4 june 2020 to 4 june 2021
mortality	mortality at 28 days	4 june 2020 to 4 june 2021
infections	number and type of infections that occurred following the operation	4 june 2020 to 4 june 2021

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Actual): June 4, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Postoperative; Delirium; CAM-ICU Score
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: ASO.Cch.19.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No