NCT04080557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

September 3, 2019

Last Update Submit

September 5, 2019

Conditions

Keywords

deliriumintensive care unitsurgical wardabdominal aortic aneurysm surgery

Outcome Measures

Primary Outcomes (1)

  • the incidence of delirium

    The incidence of delirium on the ICU and on the ward

    between january 2013 and december 2018

Secondary Outcomes (1)

  • mortality

    6 months and 12 months

Other Outcomes (5)

  • Length of hospital stay

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

  • Length of ICU stay

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

  • Reoperations

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

  • +2 more other outcomes

Study Arms (1)

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

SurgeryOTHER

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
AAA patients that went to the ICU postoperatively

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amphia hospital

Breda, North Brabant, 4818CK, Netherlands

Location

MeSH Terms

Conditions

DeliriumAortic Aneurysm, Abdominal

Interventions

Surgical Procedures, OperativeEndovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersAortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Study Officials

  • Lijckle van der Laan, MD, PhD

    Amphia hospital Breda, the Netherlands

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 6, 2019

Study Start

November 1, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations