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

NCT05089097 | Completed

• 1 other identifier: ASO.Cch.19.01
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Delirium; Postoperative; CAM-ICU Score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Correlation with ICU-Length of Stay

  4 june 2020 to 4 june 2021

• correlation with Hospital-Length of Stay

  4 june 2020 to 4 june 2021

• Bleeding

  4 june 2020 to 4 june 2021

• re-operated patient

  4 june 2020 to 4 june 2021

• mechanical ventilation in intensive care

  4 june 2020 to 4 june 2021

Study Arms (2)

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

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

Interventions

evaluation of delirium with CAM-ICU Score OTHER

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

Inhibitors of serotoninergic reuptake off; Inhibitors of serotoninergic reuptake on

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• patients over 18 years old

Sponsors & Collaborators

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

Study Sites (1)

Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: June 4, 2020
• Primary Completion: June 4, 2021
• Study Completion: September 15, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)