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Completed

NCT Number: NCT04828902

Incidence of Postoperative Delirium After Cardiac Surgery in Adults.

Postoperative delirium is an acute syndrome of mental deterioration characterized by acute onset and fluctuating course during the day. Very frequent delirium is a presage of other serious comorbidities i.e.: sepsis, acute kidney injury, circulatory and/or respiratory failure. A detailed knowledge of symptoms and early diagnose of delirium increase the chances of early therapy. To what extent the occurrence of postoperative delirium influences hospital therapy in the Cardiac Surgical Postoperative ICU in University Clinical Centre in Gdańsk is unknown so far.

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Key information

Conditions

Postoperative Delirium Adult Cardiac Surgery COVID-19 Confusion Coronaviridae Infections Coronavirus Infections Covid19 Delirium Emergence Delirium Infections Lung Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Postoperative Complications RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cadiac Anesthesiology, Medical University of Gdańsk

Gdansk, Pomeranian Voivodeship, 80-211, Poland

About this study

Study type: prospective, observational cohort study. Facility: tertiary, university hospital Methods: Patients will undergo routine, continuous observation for symptoms of delirium by a trained nursing staff. Occurrence of delirium, Delirium Observation Screening Scale (DOSS) grading, and therapy will by annotated on case record forms (CRFs) every 12 hours. Additionally, collected will be known risk factors of delirium: schedule type, age, arterial hypertension, atrial fibrillation, body mass index (BMI), angiotensin converting enzyme (ACE) inhibitors / angiotensin receptor blockers (ARBs) therapy, hearing loss, dementia, peripheral artery disease, myocardial infarction, depression, diabetes, corona virus disease 2019 (COVID19) infection and/or vaccination; and outcome data: hospital-LOS, prolonged sedation, antipsychotic therapy, surgical reintervention, hours on mechanical ventilation (HOV), number of tracheal intubations, length of consciousness disorders, blood product transfusions, cardiopulmonary resuscitation (CPR), renal replacement therapy (RRT), mechanical circulatory support (MCS), duration of catecholamine support, ICU readmissions, new antibiotic therapies, 30-day mortality.

Statistical methods: Delirium morbidity and risk will be calculated from two-by-two table. Associations between delirium and secondary outcome measures will be evaluated by simple and logistic regression with use of ANOVA test for continuous variables with homogeneous distribution, or Kruskal-Wallis test for continuous variables with non-homogeneous distribution, or categorical variables. Significant will be considered results with p<0.05.

A period of one year was assumed sufficient to draw conclusions on the primary endpoints of the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (>18 y.a.), undergoing cardiac surgery, who will sign an informed consent to participate in the study.

Exclusion criteria

  • Deny to sign or absence of an informed consent.

Treatment and study plan

cardiac surgery

Procedure

Any heart surgery on or without cardiopulmonary bypass performed under general anesthesia in the Cardiac Surgical Department, Medical University of Gdańsk.

Other names: cabg, valve surgery, aorta surgery, heart transplant, other cardiac surgery

Primary outcomes

  1. Delirium incidence and risk

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    Incidence and risk of postoperative delirium

  2. Risk factors of delirium.

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    collected will be known risk factors of delirium: schedule type, age, arterial hypertension, atrial fibrillation, BMI, ACE/ARBs therapy, hearing loss, dementia, peripheral artery disease, myocardial infarction, depression, diabetes, COVID19 and/or vaccination for it; and outcome data: hospital-LOS, prolonged sedation, antipsychotic therapy, surgical reintervention, direct coercion, length of mechanical ventilation, number of tracheal intubations, length of consciousness disorders, blood product transfusions, cardiopulmonary resuscitation, renal replacement therapy, mechanical circulatory support, duration of catecholamine support, ICU readmissions, new antibiotic therapies, 30-day mortality.

  3. Association between delirium and length of stay in ICU (LOS-ICU).

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    Association between delirium and length of stay in ICU (LOS-ICU).

Secondary outcomes

  1. DOSS

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    Associations between delirium and mean DOSS

  2. Hospital-LOS

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    Association between delirium and hospital-LOS

  3. Prolonged sedation, antipsychotic therapy and surgical re-intervention.

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    Association between delirium and prolonged sedation, antipsychotic therapy, surgical reintervention.

  4. Hours on ventilator.

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    Association between delirium and HOV.

  5. Intubations

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    Association between delirium and number of tracheal intubations.

  6. Consciousness disorders

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    Association between delirium and length of consciousness disorders.

  7. Transfusions

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    Association between delirium and blood product transfusions.

  8. CPR, RRT, MCS

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    Association between delirium and CPR, RRT, and MCS.

  9. Catecholamines

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    Association between delirium and duration of catecholamine support.

  10. ICU readmissions

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    Association between delirium and ICU readmissions.

  11. New antibiotic

    Time frame: Through hospitalisation in Postop-ICU - an average of 2 days

    Association between delirium and new antibiotic therapy.

  12. 30-day mortality

    Time frame: 30 days after operation

    Association between delirium and 30-day mortality

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

Incidence of Postoperative Delirium After Cardiac Surgery in Adults - a Prospective Observational Cohort Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2025
First posted
Apr 2, 2021
Registry last updated
May 19, 2026

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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