DeliriumNCT04080557
Abdominal Aortic Aneurysm Patients Remain at Risk for Delirium on the Surgical Ward After Intensive Care Unit Dismissal
An observational study of Delirium and AAA, run by Amphia Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Delirium, AAA, Intensive Care Unit Delirium
- What is being tested?
- Surgery
- How many people
- 135 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2018to 28 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients that did not survive surgery
- Patients that did not go to the intensive care unit postoperatively.
Trial locations and contacts
1 site in 1 country.
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.
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.
- Conditions
- Delirium, AAA, Intensive Care Unit Delirium, Surgery--Complications, Surgery, Aortic Aneurysm, Abdominal
- Being tested
- Surgery
- Keywords
- delirium, intensive care unit, surgical ward, abdominal aortic aneurysm surgery
- Medical subject headings
- Delirium, Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
Also called Open abdominal aortic repair, Endovascular aortic repair
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of delirium
The incidence of delirium on the ICU and on the ward
Measured: between january 2013 and december 2018
Secondary outcomes (1)
mortality
mortality divided by ICU delirium and ward delirium
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Nov 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amphia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joost Roijers, Amphia Hospital
- Investigators
- Lijckle van der Laan, MD, PhD, Study chair, Amphia hospital Breda, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080557
- Sponsor's protocol ID
- 305213JR
- Status last verified
- Sep 2019
- First submitted
- 3 Sep 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Aortic Aneurysm Patients Remain at Risk for Delirium on the Surgical Ward After Intensive Care Unit Dismissal
- ClinicalTrials.gov ID
- NCT04080557
- Acronym / sponsor ID
- 305213JR
- Conditions
- Delirium, AAA, Intensive Care Unit Delirium, Surgery--Complications, Surgery, Aortic Aneurysm, Abdominal
- Keywords
- delirium, intensive care unit, surgical ward, abdominal aortic aneurysm surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Amphia HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAA patients that went to the ICU postoperatively | – | Other: SurgeryAn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients that did not survive surgery
- Patients that did not go to the intensive care unit postoperatively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryAlso: Open abdominal aortic repair, Endovascular aortic repairAll 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 | AAA patients that went to the ICU postoperatively |
Primary outcome
the incidence of delirium
Time frame: between january 2013 and december 2018
The incidence of delirium on the ICU and on the ward
1 secondary outcome
mortality
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Delirium
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lijckle van der Laan, MD, PhD study chair
Amphia hospital Breda, the Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and AAA, run by Amphia Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of delirium (time frame: between january 2013 and december 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.