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Clinical Trials/NCT05089097
NCT05089097
Completed
Not Applicable

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

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria1 site in 1 country152 target enrollmentJune 4, 2020
ConditionsDelirium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Enrollment
152
Locations
1
Primary Endpoint
Presence/absence of postoperative delirium
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 4, 2020
End Date
September 15, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Responsible Party
Sponsor

Eligibility Criteria

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);

Outcomes

Primary Outcomes

Presence/absence of postoperative delirium

Time Frame: 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 Outcomes

  • re-operated patient(4 june 2020 to 4 june 2021)
  • Correlation with ICU-Length of Stay(4 june 2020 to 4 june 2021)
  • Bleeding(4 june 2020 to 4 june 2021)
  • correlation with Hospital-Length of Stay(4 june 2020 to 4 june 2021)
  • mechanical ventilation in intensive care(4 june 2020 to 4 june 2021)
  • infections(4 june 2020 to 4 june 2021)
  • mortality(4 june 2020 to 4 june 2021)

Study Sites (1)

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