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OpenTrials
Completed

NCT Number: NCT05089097

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. 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

  1. Correlation with ICU-Length of Stay

    Time frame: 4 june 2020 to 4 june 2021

    Correlation with ICU-Length of Stay

  2. correlation with Hospital-Length of Stay

    Time frame: 4 june 2020 to 4 june 2021

    correlation with Hospital-Length of Stay

  3. Bleeding

    Time frame: 4 june 2020 to 4 june 2021

    measure of bleeding in ml / day

  4. re-operated patient

    Time frame: 4 june 2020 to 4 june 2021

    Number of re-operated patient

  5. mechanical ventilation in intensive care

    Time frame: 4 june 2020 to 4 june 2021

    number of patients who required mechanical ventilation in the ICU

  6. mortality

    Time frame: 4 june 2020 to 4 june 2021

    mortality at 28 days

  7. infections

    Time frame: 4 june 2020 to 4 june 2021

    number and type of infections that occurred following the operation

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Other

Registry information

Acronym: DeCAMS-ON

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2021
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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