DeliriumNCT01698125
Autonomic Cardiovascular Control for Elderly Surgery Patients
An observational study of Delirium, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to study aspects of autonomic cardiovascular control and the level of stress hormones and inflammatory markers in saliva or serum, in elderly patients exposed to elective, major abdominal surgery, with or without postoperative delirium, to explore the hypothesis that delirium may be the… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Abdominal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2012to Nov 2012
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients scheduled for abdominal surgery at Oslo University Hospital.
Who may be able to join
- Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital
Who cannot join
- Absence of a valid informed consent or assent, or consent from a legal proxy
- Patients with atrial fibrillation or a pacemaker rhythm
- Polyneuropathy
- Current treatment with beta-blockers, calcium-blockers or cholinesterase inhibitors
- Competing research project
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to study aspects of autonomic cardiovascular control and the level of stress hormones and inflammatory markers in saliva or serum, in elderly patients exposed to elective, major abdominal surgery, with or without postoperative delirium, to explore the hypothesis that delirium may be the result of aberrant stress responses.
Read the detailed description
Patients admitted for elective, major, abdominal surgery will be tested with a head-up tilting to 20 degrees for 15 minutes preoperatively and again on the second postoperative day. Haemodynamic variables will be registered by the device TaskForceMonitor which monitors heart rate (HR), electrocardiography (ECG), blood pressure and stroke volume continuously and non-invasively.
Background variables (including demographics, comorbidity and simple cognitive tests) and daily variables (including delirium assessments) will be registered.
Blood and saliva samples will be drawn preoperatively and postoperatively to measure levels of stress hormones and inflammatory markers.
- Conditions
- Delirium
- Being tested
- Abdominal surgery
- Keywords
- Delirium, Autonomic cardiovascular control, Abdominal surgery, Tilt-test
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal surgeryProcedure or surgery
Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital
| Study group | Role | What they receive |
|---|---|---|
| Abdominal surgery | Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital Receives: Procedure: Abdominal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in orthostatic cardiovascular responses
Change in orthostatic cardiovascular responses (head-up tilt test) pre- and postoperatively in patients with and without postoperative delirium will be evaluated based on measurements of heart rate, systolic blood pressure (BP), mean BP, diastolic BP, stroke index, total peripheral resistance index, end-diastolic volume index, and acceleration index.
Measured: Baseline and postoperatively at surgical ward (expected second postoperative day)
Secondary outcomes (8)
Barthel Activities of Daily Living (ADL) Scale
Score from 0-20 points
Measured: Baseline
Nottingham Extended Activity of Daily Living (NEADL) Scale
Score from 0-66 points.
Measured: Baseline
Cumulative Illness Rating Scale
Total score from 0-56.
Measured: Baseline
Dementia
Simple cognitive tests preformed preoperatively, including MMSE, Clock Drawing Test, Trail making A and B and Ten word memory test. Also IQCODE when reliable information is present.
Measured: Baseline
Delirium
Daily assessing the patient using the Confusion Assessment Method (CAM), shortened version.
Measured: Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days.
Cortisol
Looking for differences in levels of cortisol in saliva (morning samples) pre-and postoperatively in patients developing delirium compared to patients not developing delirium.
Measured: Baseline and second postoperative day
Severity of delirium
Daily assessing the patient using MDAS (the memorial delirium assessment scale). Total score from 0-30.
Measured: Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days
Gait speed
Measuring comfortable gait speed at length of 4 meters, best result of 2 tests. Result in meter per second.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Practical circumstances made it too difficult to carry out as planned.
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.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Sponsor
- Investigators
- Torgeir B Wyller, MD, Prof, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698125
- Sponsor's protocol ID
- 2011/2498/REK nord
- Status last verified
- Apr 2014
- First submitted
- 27 Sep 2012
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Cardiovascular Control for Elderly Surgery Patients
- ClinicalTrials.gov ID
- NCT01698125
- Acronym / sponsor ID
- 2011/2498/REK nord
- Conditions
- Delirium
- Keywords
- Delirium, Autonomic cardiovascular control, Abdominal surgery, Tilt-test
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Practical circumstances made it too difficult to carry out as planned.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- Oct 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 2 Oct 2012 (estimated)
- 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 purpose of this study is to study aspects of autonomic cardiovascular control and the level of stress hormones and inflammatory markers in saliva or serum, in elderly patients exposed to elective, major abdominal surgery, with or without postoperative delirium, to explore the hypothesis that delirium may be the result of aberrant stress responses.
Detailed description
Patients admitted for elective, major, abdominal surgery will be tested with a head-up tilting to 20 degrees for 15 minutes preoperatively and again on the second postoperative day. Haemodynamic variables will be registered by the device TaskForceMonitor which monitors heart rate (HR), electrocardiography (ECG), blood pressure and stroke volume continuously and non-invasively.
Background variables (including demographics, comorbidity and simple cognitive tests) and daily variables (including delirium assessments) will be registered.
Blood and saliva samples will be drawn preoperatively and postoperatively to measure levels of stress hormones and inflammatory markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal surgery | – | Procedure: Abdominal surgeryPatients 65 years or older scheduled for abdominal surgery at Oslo University Hospital |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients scheduled for abdominal surgery at Oslo University Hospital.
Key inclusion criteria (1 listed)
- Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital
Key exclusion criteria (5 listed)
- Absence of a valid informed consent or assent, or consent from a legal proxy
- Patients with atrial fibrillation or a pacemaker rhythm
- Polyneuropathy
- Current treatment with beta-blockers, calcium-blockers or cholinesterase inhibitors
- Competing research project
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 |
|---|---|---|
| Abdominal surgeryPatients 65 years or older scheduled for abdominal surgery at Oslo University Hospital | Procedure or surgery | Abdominal surgery |
Primary outcome
Change in orthostatic cardiovascular responses
Time frame: Baseline and postoperatively at surgical ward (expected second postoperative day)
Change in orthostatic cardiovascular responses (head-up tilt test) pre- and postoperatively in patients with and without postoperative delirium will be evaluated based on measurements of heart rate, systolic blood pressure (BP), mean BP, diastolic BP, stroke index, total peripheral resistance index, end-diastolic volume index, and acceleration index.
8 secondary outcomes
Barthel Activities of Daily Living (ADL) Scale
Time frame: Baseline
Nottingham Extended Activity of Daily Living (NEADL) Scale
Time frame: Baseline
Cumulative Illness Rating Scale
Time frame: Baseline
Dementia
Time frame: Baseline
Delirium
Time frame: Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days.
Cortisol
Time frame: Baseline and second postoperative day
Severity of delirium
Time frame: Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days
Gait speed
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Practical circumstances made it too difficult to carry out as planned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
Related trials for Delirium
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
RecruitingPhase 4
Acetaminophen-Mannitol Injection and Postoperative Delirium
Postoperative Delirium
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Not yet recruitingObservational study
Biomarkers of Postoperative Complications After Cardiac Surgery
Postoperative Complications
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
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.
Torgeir B Wyller, MD, Prof study director
Oslo University Hospital
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, run by Oslo University Hospital at 1 site in Norway.
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 5 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: stopped early, as of the sponsor's last update on 15 Apr 2014. 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 Norway. 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 was stopped early (reason given: Practical circumstances made it too difficult to carry out as planned.). Results are not available in the source record.
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?
Change in orthostatic cardiovascular responses (time frame: Baseline and postoperatively at surgical ward (expected second postoperative day)). 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 15 Apr 2014.