CClinicalTrials.gg
CompletedNCT04080557Updated Sep 6, 2019

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

An observational study in Delirium, AAA and Intensive Care Unit Delirium, sponsored by Amphia Hospital. Completed at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2019-09-06.

Sponsored by Amphia Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
135
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • delirium
  • intensive care unit
  • surgical ward
  • abdominal aortic aneurysm surgery
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

  • Patients that did not survive surgery
  • Patients that did not go to the intensive care unit postoperatively.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
135 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherSurgery

    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.

    Also known as: Open abdominal aortic repair, Endovascular aortic repair

05

What researchers measure

Primary outcomes

  1. the incidence of delirium

    The incidence of delirium on the ICU and on the ward

    Time frame: between january 2013 and december 2018

Secondary outcomes

  1. mortality

    mortality divided by ICU delirium and ward delirium

    Time frame: 6 months and 12 months

Other outcomes

  1. Length of hospital stay

    Length of hospital stay in days

    Time frame: Data on re-interventions, readmissions and survival were collected until February 2019.

  2. Length of ICU stay

    Length of ICU stay in days

    Time frame: Data on re-interventions, readmissions and survival were collected until February 2019.

  3. Reoperations

    Reoperations within 30 days after surgery

    Time frame: Data on re-interventions, readmissions and survival were collected until February 2019.

  4. Complications

    Complications within 30 days after surgery

    Time frame: Data on re-interventions, readmissions and survival were collected until February 2019.

  5. Discharge to a nursing home

    Discharge to a nursing home

    Time frame: Data on re-interventions, readmissions and survival were collected until February 2019.

06

Study locations

1 site
  • Amphia hospital
    Breda, Noord-Brabant 4818CK, Netherlands
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04080557
Lead sponsor
Amphia Hospital
Responsible party
Joost Roijers (Principal Investigator, Amphia Hospital) — Principal investigator
First posted
Sep 6, 2019
Start date
Nov 1, 2018
Primary completion
Feb 28, 2019
Completion
Feb 28, 2019
Last update
Sep 6, 2019

Study contacts

Lijckle van der Laan, MD, PhD
study chair · Amphia hospital Breda, the Netherlands

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion