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

September 5, 2019 updated by: Joost Roijers, Amphia Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Brabant
      • Breda, Noord-Brabant, Netherlands, 4818CK
        • Amphia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AAA patients that went to the ICU postoperatively
An retrospective 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.
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.
Other Names:
  • Open abdominal aortic repair
  • Endovascular aortic repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of delirium
Time Frame: between january 2013 and december 2018
The incidence of delirium on the ICU and on the ward
between january 2013 and december 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 6 months and 12 months
mortality divided by ICU delirium and ward delirium
6 months and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Data on re-interventions, readmissions and survival were collected until February 2019.
Length of hospital stay in days
Data on re-interventions, readmissions and survival were collected until February 2019.
Length of ICU stay
Time Frame: Data on re-interventions, readmissions and survival were collected until February 2019.
Length of ICU stay in days
Data on re-interventions, readmissions and survival were collected until February 2019.
Reoperations
Time Frame: Data on re-interventions, readmissions and survival were collected until February 2019.
Reoperations within 30 days after surgery
Data on re-interventions, readmissions and survival were collected until February 2019.
Complications
Time Frame: Data on re-interventions, readmissions and survival were collected until February 2019.
Complications within 30 days after surgery
Data on re-interventions, readmissions and survival were collected until February 2019.
Discharge to a nursing home
Time Frame: Data on re-interventions, readmissions and survival were collected until February 2019.
Discharge to a nursing home
Data on re-interventions, readmissions and survival were collected until February 2019.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amphia Hospital

Investigators

  • Study Chair: Lijckle van der Laan, MD, PhD, Amphia Hospital Breda, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 305213JR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Delirium

Clinical Trials on Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe