Incidence of Postoperative Delirium After Cardiac Surgery in Adults.

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04828902
• Other study ID #: NKBBN/4421/2020
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: April 2021
• Source: Medical University of Gdansk
• Contact: Maciej M Kowalik, Dr. hab.
• Phone: +48585844209
• Email: mkowalik[@]gumed.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adult Cardiac Surgery
• Covid19
• Delirium
• Postoperative Delirium

Intervention

Procedure:
• cardiac surgery
Any heart surgery on or without cardiopulmonary bypass performed under general anesthesia in the Cardiac Surgical Department, Medical University of Gdansk.

Locations

Country	Name	City	State
Poland	Department of Cadiac Anesthesiology, Medical University of Gdansk	Gdansk	Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium incidence and risk	Incidence and risk of postoperative delirium	Through hospitalisation in Postop-ICU - an average of 2 days
Primary	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
Primary	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	DOSS	Associations between delirium and mean DOSS	Through hospitalisation in Postop-ICU - an average of 2 days
Secondary	Hospital-LOS	Association between delirium and hospital-LOS	Through hospitalisation in Postop-ICU - an average of 2 days
Secondary	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
Secondary	Hours on ventilator.	Association between delirium and HOV.	Through hospitalisation in Postop-ICU - an average of 2 days
Secondary	Intubations	Association between delirium and number of tracheal intubations.	Through hospitalisation in Postop-ICU - an average of 2 days
Secondary	Consciousness disorders	Association between delirium and length of consciousness disorders.	Through hospitalisation in Postop-ICU - an average of 2 days
Secondary	Transfusions	Association between delirium and blood product transfusions.	Through hospitalisation in Postop-ICU - an average of 2 days
Secondary	CPR, RRT, MCS	Association between delirium and CPR, RRT, and MCS.	Through hospitalisation in Postop-ICU - an average of 2 days
Secondary	Catecholamines	Association between delirium and duration of catecholamine support.	Through hospitalisation in Postop-ICU - an average of 2 days
Secondary	ICU readmissions	Association between delirium and ICU readmissions.	Through hospitalisation in Postop-ICU - an average of 2 days
Secondary	New antibiotic	Association between delirium and new antibiotic therapy.	Through hospitalisation in Postop-ICU - an average of 2 days
Secondary	30-day mortality	Association between delirium and 30-day mortality	30 days after operation