Clinical trial NCT04080557: Abdominal Aortic Aneurysm Patients Remain at Risk for Delirium on the Surgical Ward After Intensive Care Unit Dismissal
Official title: Abdominal Aortic Aneurysm Patients Remain at Risk for Delirium on the Surgical Ward After Intensive Care Unit Dismissal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
AAA
Intensive Care Unit Delirium
Surgery--Complications
Surgery
Aortic Aneurysm, Abdominal
Keywords: delirium
intensive care unit
surgical ward
abdominal aortic aneurysm surgery
Lead sponsor: Amphia Hospital
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 135
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 135 patients were included in the study. Of these, 72 were treated for a ruptured abdominal aortic aneurysm and 63 were treated electively with open aortic repair.

Brief summary: The incidence of delirium following open abdominal aortic aneurysm (AAA) surgery is significant, with incidence rates ranging from 12 to 33%. The occurrence of delirium on the surgical ward after intensive care unit (ICU) dismissal in AAA patients remains unclear. Differences in outcomes between a delirium on the ICU and a delirium on the surgical ward have not been previously investigated.

Delirium is a frequent complication in patients who underwent open AAA surgery. This study demonstrated that patients on the surgical ward remain at risk for developing a delirium after ICU dismissal. Physicians should therefore maintain a high level of awareness for delirium in AAA patients who return to the surgical ward after ICU dismissal. This simultaneously emphasises the necessity of delirium preventive measures and early recognition on the surgical ward in order to improve clinical outcomes.

Detailed description: The incidence of delirium following open abdominal aortic aneurysm (AAA) surgery is significant, with incidence rates ranging from 12 to 33%. The occurrence of delirium on the surgical ward after intensive care unit (ICU) dismissal in AAA patients remains unclear. Differences in outcomes between a delirium on the ICU and a delirium on the surgical ward have not been previously investigated.

An observational cohort study was conducted that included all patients treated electively for an abdominal aortic aneurysm (AAA) by open repair and patients undergoing emergency treatment for a ruptured AAA between 2013 and 2018. The diagnosis of delirium was verified by a psychiatrist or geriatrician using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria. Cox proportional hazards regression analysis was used to analyse 6- and 12-months survival rate.

Eligibility criteria: Inclusion Criteria:

* All patients treated electively for an abdominal aortic aneurysm (AAA) by open repair and patients undergoing emergency treatment for a ruptured AAA between 2013 and 2018.

Exclusion Criteria:

* Patients that did not survive surgery
* Patients that did not go to the intensive care unit postoperatively.

Primary outcomes:
measure: the incidence of delirium
timeFrame: between january 2013 and december 2018
Secondary outcomes:
measure: mortality
timeFrame: 6 months and 12 months
Other outcomes:
measure: Length of hospital stay
timeFrame: Data on re-interventions, readmissions and survival were collected until February 2019.
measure: Length of ICU stay
timeFrame: Data on re-interventions, readmissions and survival were collected until February 2019.
measure: Reoperations
timeFrame: Data on re-interventions, readmissions and survival were collected until February 2019.
measure: Complications
timeFrame: Data on re-interventions, readmissions and survival were collected until February 2019.
measure: Discharge to a nursing home
timeFrame: Data on re-interventions, readmissions and survival were collected until February 2019.
Locations:
city: Breda
country: Netherlands
facility: Amphia hospital
state: Noord-Brabant
Study officials:
affiliation: Amphia hospital Breda, the Netherlands
name: Lijckle van der Laan, MD, PhD
role: STUDY_CHAIR
References: