Incidence of Postoperative Delirium After Cardiac Surgery in Adults.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Postoperative Delirium; Adult Cardiac Surgery
• Intervention / Treatment: Procedure: cardiac surgery

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Maciej M Kowalik, Dr. hab.; Phone Number: +48585844209; Email: mkowalik@gumed.edu.pl
• Study Contact Backup: Name: Paweł Kozak, Mgr. piel.; Phone Number: +48585844208; Email: Paweł.kozak@gumed.edu.pl

Study Locations

• Poland
  • Pomorskie
    • Gdańsk, Pomorskie, Poland, 80-211
      • Recruiting
      • Department of Cadiac Anesthesiology, Medical University of Gdańsk
      • Contact: Paweł Kozak, Mgr. piel.; Phone Number: +48585844208; Email: Paweł.kozak@gumed.edu.pl
      • Contact: Maciej M Kowalik, Dr hab.; Phone Number: +48585844209; Email: mkowalik@gumed.edu.pl
      • Sub-Investigator: Maciej M Kowalik, M.D., Ph.D.
      • Principal Investigator: Paweł Kozak, Mgr. Piel.

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: Non-Probability Sample

Study Population

All adult patients undergoing elective/emergency cardiac surgery will be considered eligible.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium incidence and risk	Incidence and risk of postoperative delirium	Through hospitalisation in Postop-ICU - an average of 2 days
Risk factors of delirium.	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.	Through hospitalisation in Postop-ICU - an average of 2 days
Association between delirium and length of stay in ICU (LOS-ICU).	Association between delirium and length of stay in ICU (LOS-ICU).	Through hospitalisation in Postop-ICU - an average of 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DOSS	Associations between delirium and mean DOSS	Through hospitalisation in Postop-ICU - an average of 2 days
Hospital-LOS	Association between delirium and hospital-LOS	Through hospitalisation in Postop-ICU - an average of 2 days
Prolonged sedation, antipsychotic therapy and surgical re-intervention.	Association between delirium and prolonged sedation, antipsychotic therapy, surgical reintervention.	Through hospitalisation in Postop-ICU - an average of 2 days
Hours on ventilator.	Association between delirium and HOV.	Through hospitalisation in Postop-ICU - an average of 2 days
Intubations	Association between delirium and number of tracheal intubations.	Through hospitalisation in Postop-ICU - an average of 2 days
Consciousness disorders	Association between delirium and length of consciousness disorders.	Through hospitalisation in Postop-ICU - an average of 2 days
Transfusions	Association between delirium and blood product transfusions.	Through hospitalisation in Postop-ICU - an average of 2 days
CPR, RRT, MCS	Association between delirium and CPR, RRT, and MCS.	Through hospitalisation in Postop-ICU - an average of 2 days
Catecholamines	Association between delirium and duration of catecholamine support.	Through hospitalisation in Postop-ICU - an average of 2 days
ICU readmissions	Association between delirium and ICU readmissions.	Through hospitalisation in Postop-ICU - an average of 2 days
New antibiotic	Association between delirium and new antibiotic therapy.	Through hospitalisation in Postop-ICU - an average of 2 days
30-day mortality	Association between delirium and 30-day mortality	30 days after operation

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Study Chair: Romuald Lango, Prof.dr.hab., Medical University of Gdańsk, Department of Cardiac Anesthesiology; Study Director: Maciej Kowalik, Dr hab., Medical University of Gdańsk, Department of Cardiac Anesthesiology; Principal Investigator: Pawel Kozak, Mgr. Piel., Medical University of Gdańsk, Department of Cardiac Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: March 21, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: cardiac surgery; Covid19; postoperative delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; COVID-19; Delirium
• Other Study ID Numbers: NKBBN/4421/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Anonymized patients data are planned to be uploaded into a public data repository (ZENODO.com) after data completion.

Drug and device information, study documents

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