Clinical trial NCT04828902: Incidence of Postoperative Delirium After Cardiac Surgery in Adults.
Official title: Incidence of Postoperative Delirium After Cardiac Surgery in Adults - a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Delirium
Adult Cardiac Surgery
Covid19
Keywords: postoperative delirium
cardiac surgery
Covid19
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients undergoing elective/emergency cardiac surgery will be considered eligible.

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.

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.

Primary outcomes:
measure: Delirium incidence and risk
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
measure: Risk factors of delirium.
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
measure: Association between delirium and length of stay in ICU (LOS-ICU).
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
Secondary outcomes:
measure: DOSS
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
measure: Hospital-LOS
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
measure: Prolonged sedation, antipsychotic therapy and surgical re-intervention.
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
measure: Hours on ventilator.
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
measure: Intubations
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
measure: Consciousness disorders
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
measure: Transfusions
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
measure: CPR, RRT, MCS
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
measure: Catecholamines
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
measure: ICU readmissions
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
measure: New antibiotic
timeFrame: Through hospitalisation in Postop-ICU - an average of 2 days
measure: 30-day mortality
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Department of Cadiac Anesthesiology, Medical University of Gdańsk
state: Pomorskie
Study officials:
affiliation: Medical University of Gdańsk, Department of Cardiac Anesthesiology
name: Romuald Lango, Prof.dr.hab.
role: STUDY_CHAIR
affiliation: Medical University of Gdańsk, Department of Cardiac Anesthesiology
name: Maciej Kowalik, Dr hab.
role: STUDY_DIRECTOR
affiliation: Medical University of Gdańsk, Department of Cardiac Anesthesiology
name: Pawel Kozak, Mgr. Piel.
role: PRINCIPAL_INVESTIGATOR
References: