Incidence of Postoperative Delirium After Cardiac Surgery in Adults.

NCT ID: NCT04828902

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-08-31

Brief Summary

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.

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.

Conditions

Postoperative Delirium; Adult Cardiac Surgery; Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

cardiac surgery

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

Intervention Type: PROCEDURE

Other Intervention Names

cabg; valve surgery; aorta surgery; heart transplant; other cardiac surgery

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Gdansk

OTHER

Sponsor Role: lead

Responsible Party

Maciej M. Kowalik, MD, PhD

Promotor, Dr hab. n. med. Maciej Michał Kowalik

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Romuald Lango, Prof.dr.hab.

Role: STUDY_CHAIR

Medical University of Gdańsk, Department of Cardiac Anesthesiology

Maciej Kowalik, Dr hab.

Role: STUDY_DIRECTOR

Medical University of Gdańsk, Department of Cardiac Anesthesiology

Pawel Kozak, Mgr. Piel.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Gdańsk, Department of Cardiac Anesthesiology

Locations

Department of Cadiac Anesthesiology, Medical University of Gdańsk

Gdansk, Pomeranian Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Maciej M Kowalik, Dr. hab.

Role: CONTACT

mkowalik@gumed.edu.pl

+48585844209

Paweł Kozak, Mgr. Piel.

Role: CONTACT

Paweł.kozak@gumed.edu.pl

+48585844208

Facility Contacts

Maciej M Kowalik, Dr hab.

Role: primary

mkowalik@gumed.edu.pl

+48585844209

Paweł Kozak, Mgr. piel.

Role: backup

Paweł.kozak@gumed.edu.pl

+48585844208

Other Identifiers

NKBBN/4421/2020

Identifier Type: -

Identifier Source: org_study_id