Incidence of Postoperative Delirium After Cardiac Surgery in Adults.

NCT04828902 | Unknown

• 1 other identifier: NKBBN/4421/2020
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium; Adult Cardiac Surgery; Covid19

Keywords

postoperative delirium; cardiac surgery; Covid19

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• DOSS

  Through hospitalisation in Postop-ICU - an average of 2 days

• Hospital-LOS

  Through hospitalisation in Postop-ICU - an average of 2 days

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

  Through hospitalisation in Postop-ICU - an average of 2 days

• Hours on ventilator.

  Through hospitalisation in Postop-ICU - an average of 2 days

• Intubations

  Through hospitalisation in Postop-ICU - an average of 2 days

Interventions

cardiac surgery PROCEDURE

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

Also known as: cabg, valve surgery, aorta surgery, heart transplant, other cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender will be reported as declared by the subjects.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Deny to sign or absence of an informed consent.

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Department of Cadiac Anesthesiology, Medical University of Gdańsk

Gdansk, Pomeranian Voivodeship, 80-211, Poland

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; COVID-19

Interventions

Cardiac Surgical Procedures; Coronary Artery Bypass; Heart Transplantation

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Myocardial Revascularization; Vascular Grafting; Vascular Surgical Procedures; Organ Transplantation; Transplantation

Study Officials

• Romuald Lango, Prof.dr.hab.

  Medical University of Gdańsk, Department of Cardiac Anesthesiology

  STUDY CHAIR

• Maciej Kowalik, Dr hab.

  Medical University of Gdańsk, Department of Cardiac Anesthesiology

  STUDY DIRECTOR

• Pawel Kozak, Mgr. Piel.

  Medical University of Gdańsk, Department of Cardiac Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maciej M Kowalik, Dr. hab.

CONTACT

+48585844209; mkowalik@gumed.edu.pl

Paweł Kozak, Mgr. Piel.

CONTACT

+48585844208; Paweł.kozak@gumed.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Promotor, Dr hab. n. med. Maciej Michał Kowalik

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: April 2, 2021
• Study Start: February 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: August 31, 2022
• Last Updated: April 15, 2021

Record last verified: 2021-04

Locations

PL (1)