Abdominal Aortic Aneurysm Patients Remain at Risk for Delirium on the Surgical Ward After Intensive Care Unit Dismissal

Surgery Clinical Trial

Official title:

Abdominal Aortic Aneurysm Patients Remain at Risk for Delirium on the Surgical Ward After Intensive Care Unit Dismissal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080557
• Other study ID #: 305213JR
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: September 2019
• Source: Amphia Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• AAA
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Delirium
• Intensive Care Unit Delirium
• Surgery
• Surgery--Complications

Intervention

Other:
• Surgery
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.

Locations

Country	Name	City	State
Netherlands	Amphia hospital	Breda	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Amphia Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay	Length of hospital stay in days	Data on re-interventions, readmissions and survival were collected until February 2019.
Other	Length of ICU stay	Length of ICU stay in days	Data on re-interventions, readmissions and survival were collected until February 2019.
Other	Reoperations	Reoperations within 30 days after surgery	Data on re-interventions, readmissions and survival were collected until February 2019.
Other	Complications	Complications within 30 days after surgery	Data on re-interventions, readmissions and survival were collected until February 2019.
Other	Discharge to a nursing home	Discharge to a nursing home	Data on re-interventions, readmissions and survival were collected until February 2019.
Primary	the incidence of delirium	The incidence of delirium on the ICU and on the ward	between january 2013 and december 2018
Secondary	mortality	mortality divided by ICU delirium and ward delirium	6 months and 12 months