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Completed

NCT Number: NCT04080557

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

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.

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Key information

Conditions

Delirium AAA Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Confusion Intensive Care Unit Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery Surgery--Complications Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Amphia hospital

Breda, North Brabant, 4818CK, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SURGERY

Other

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

Primary outcomes

  1. the incidence of delirium

    Time frame: between january 2013 and december 2018

    The incidence of delirium on the ICU and on the ward

Secondary outcomes

  1. mortality

    Time frame: 6 months and 12 months

    mortality divided by ICU delirium and ward delirium

Other outcomes

  1. Length of hospital stay

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

    Length of hospital stay in days

  2. Length of ICU stay

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

    Length of ICU stay in days

  3. Reoperations

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

    Reoperations within 30 days after surgery

  4. Complications

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

    Complications within 30 days after surgery

  5. Discharge to a nursing home

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

    Discharge to a nursing home

Sponsors and collaborators

Lead sponsor

Amphia Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2019
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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