DeliriumADOMNCT01827501
Avoidance of Delirium in Older Patients After Major Non-cardiac Surgery
A study testing PulsioflexTM Monitoring in people with Delirium, run by Technical University of Munich at 1 site in Germany.
Trial summary
This study is designed to compare the incidence of postoperative delirium in older patients after major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group and a control group Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- PulsioflexTM Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Feb 2021
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 70 years
- Risk of perioperative delirium (Marcantonio) ≥6
Who cannot join
- Emergency surgery
- Valvular disorders grad II or higher
- History of major aortic surgery
- Major aortic surgery
- Repeated surgery (within 30 days before)
- Neurosurgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Anästhesiologie Klinikum Rechts der Isar
Munich, 81675
About this study
Official title: Can Perioperative Goal Directed Hemodynamic Management Reduce the Incidence of Delirium in Older Patients After Major Non-cardiac Surgery?
This study is designed to compare the incidence of postoperative delirium in older patients after major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group and a control group
Read the detailed description
Delirium is a common postoperative complication in the elderly. The incidence depends on several factors like the comorbidities of the patient and the type of surgery. Mortality is almost twofold increased after two years for patients suffering from delirium after surgery. Different studies showed that with a multimodal strategy it was possible to reduce the risk of delirium. As several different organ systems are involved in the development of delirium the patient's hemodynamic state seems to be important and is a target point of intervention. Also sufficient perfusion and oxygen delivery is essential in order to avoid impairment of the brain. Recent studies showed that goal directed hemodynamic management can reduce all kind of postoperative complications and improve outcome. However, whether the use of goal-directed hemodynamic management also improves the neurological outcome and reduces the rates of postoperative delirium has not been studied yet.
Aim of this study is to investigate the impact of goal directed hemodynamic management using pulse contour analysis on the incidence of delirium in older patients undergoing non-cardiac surgery, presenting with an intermediate to high risk for delirium. This risk will be assessed preoperatively using a score suggested by Marcantonio.
Patients will be randomized in one of two groups, the goal-directed therapy group and the control group. In the goal-directed therapy (GDT) group hemodynamic management is performed according to an established algorithm obtained by pulse contour analysis. To prove our theory that goal-directed therapy influences the brain by increasing oxygen supply we will use near infrared spectroscopy, which is safe and non-invasive, in our patients. The hemodynamic management is continued in the recovery room or at the intensive care unit according to the mentioned algorithm. The intervention will be terminated as soon as patients fulfil the standard criteria for discharge from recovery room or intensive care.
In the control group hemodynamic management is performed according to heart rate and blood pressure without using extended monitoring.
As the actual incidence has a significant impact on the number needed per group, we are going to perform an interims analysis after 100 included patients according to the O'Brian-Fleming technique. Is the difference of delirium between the two groups significant with an α < 0,002 the study will be finished. Otherwise, the sample size needed per group will be determined assuming an α = 0,048, a two-tailed test and a power of 80%.
UPDATE 19-10-2016:
The interims-analysis of incidences after 100 patients revealed, that 86 patients per group will be needed (α = 0,048, power 80%).
- Conditions
- Delirium
- Being tested
- PulsioflexTM Monitoring
- Keywords
- postoperative delirium, hemodynamic management, goal directed therapy
- Medical subject headings
- Delirium, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulsioflexTM MonitoringDevice
Fluid and catecholamine management according to PulsioflexTM measurements
| Study group | Role | What they receive |
|---|---|---|
| Group GDT | Experimental | Goal-directed Management according to pulse contour analysis (PulsioflexTM Monitoring) Receives: Device: PulsioflexTM Monitoring |
| Group Co | No intervention | Conventional fluid management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium until day 7 (CAM-Score and clinical diagnosis)
Delirium according to CAM-Score and clinical diagnosis
Measured: Before induction of anesthesia until 7 days after surgery
Secondary outcomes (5)
Factors defining delirium
Duration of delirium, total amount of haloperidol administered
Measured: 7 days
Short-term cognitive impairment
Mini Mental State on day 7
Measured: 7 days
Mortality
in-hospital mortality, mortality after one year
Measured: 1 year
Influence on brain oxygen saturation
Influence of GDT on the frontal oxygen saturation of the brain assessed with Near-InfraRed-Spectroscopy (NIRS)-Monitoring
Measured: until discharge from recovery room/ICU
Intra- and postoperative Measurements
Time until discharge, total fluids and amount of catecholamines administered, incidence of overall postoperative complications
Measured: Until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2019
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bettina Jungwirth, MD, Principal investigator, Klinik für Anaesthesiologie Technische Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827501
- Sponsor's protocol ID
- ADOM
- Acronym
- ADOM
- Status last verified
- Mar 2021
- First submitted
- 4 Apr 2013
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Marcantonio ER. Postoperative delirium: a 76-year-old woman with delirium following surgery. JAMA. 2012 Jul 4;308(1):73-81. doi: 10.1001/jama.2012.6857.
PubMed 22669559Fuest KE, Servatius A, Ulm B, Schaller SJ, Jungwirth B, Blobner M, Schmid S. Perioperative Hemodynamic Optimization in Patients at Risk for Delirium - A Randomized-Controlled Trial. Front Med (Lausanne). 2022 Jul 13;9:893459. doi: 10.3389/fmed.2022.893459. eCollection 2022.
PubMed 35935775
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Perioperative Goal Directed Hemodynamic Management Reduce the Incidence of Delirium in Older Patients After Major Non-cardiac Surgery?
- ClinicalTrials.gov ID
- NCT01827501
- Acronym / sponsor ID
- ADOM / ADOM
- Conditions
- Delirium
- Keywords
- postoperative delirium, hemodynamic management, goal directed therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2019 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 9 Apr 2013 (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.
This study is designed to compare the incidence of postoperative delirium in older patients after major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group and a control group
Detailed description
Delirium is a common postoperative complication in the elderly. The incidence depends on several factors like the comorbidities of the patient and the type of surgery. Mortality is almost twofold increased after two years for patients suffering from delirium after surgery. Different studies showed that with a multimodal strategy it was possible to reduce the risk of delirium. As several different organ systems are involved in the development of delirium the patient's hemodynamic state seems to be important and is a target point of intervention. Also sufficient perfusion and oxygen delivery is essential in order to avoid impairment of the brain. Recent studies showed that goal directed hemodynamic management can reduce all kind of postoperative complications and improve outcome. However, whether the use of goal-directed hemodynamic management also improves the neurological outcome and reduces the rates of postoperative delirium has not been studied yet.
Aim of this study is to investigate the impact of goal directed hemodynamic management using pulse contour analysis on the incidence of delirium in older patients undergoing non-cardiac surgery, presenting with an intermediate to high risk for delirium. This risk will be assessed preoperatively using a score suggested by Marcantonio.
Patients will be randomized in one of two groups, the goal-directed therapy group and the control group. In the goal-directed therapy (GDT) group hemodynamic management is performed according to an established algorithm obtained by pulse contour analysis. To prove our theory that goal-directed therapy influences the brain by increasing oxygen supply we will use near infrared spectroscopy, which is safe and non-invasive, in our patients. The hemodynamic management is continued in the recovery room or at the intensive care unit according to the mentioned algorithm. The intervention will be terminated as soon as patients fulfil the standard criteria for discharge from recovery room or intensive care.
In the control group hemodynamic management is performed according to heart rate and blood pressure without using extended monitoring.
As the actual incidence has a significant impact on the number needed per group, we are going to perform an interims analysis after 100 included patients according to the O'Brian-Fleming technique. Is the difference of delirium between the two groups significant with an α < 0,002 the study will be finished. Otherwise, the sample size needed per group will be determined assuming an α = 0,048, a two-tailed test and a power of 80%.
UPDATE 19-10-2016:
The interims-analysis of incidences after 100 patients revealed, that 86 patients per group will be needed (α = 0,048, power 80%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group GDT | Experimental | Device: PulsioflexTM MonitoringGoal-directed Management according to pulse contour analysis (PulsioflexTM Monitoring) |
| Group Co | No intervention | –Conventional fluid management |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age ≥ 70 years
- Risk of perioperative delirium (Marcantonio) ≥6
Key exclusion criteria (6 listed)
- Emergency surgery
- Valvular disorders grad II or higher
- History of major aortic surgery
- Major aortic surgery
- Repeated surgery (within 30 days before)
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 |
|---|---|---|
| PulsioflexTM MonitoringFluid and catecholamine management according to PulsioflexTM measurements | Device | Group GDT |
Primary outcome
Incidence of delirium until day 7 (CAM-Score and clinical diagnosis)
Time frame: Before induction of anesthesia until 7 days after surgery
Delirium according to CAM-Score and clinical diagnosis
5 secondary outcomes
Factors defining delirium
Time frame: 7 days
Short-term cognitive impairment
Time frame: 7 days
Mortality
Time frame: 1 year
Influence on brain oxygen saturation
Time frame: until discharge from recovery room/ICU
Intra- and postoperative Measurements
Time frame: Until discharge
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 8 Apr 2021.
- Background: PubMed 22669559Marcantonio ER. Postoperative delirium: a 76-year-old woman with delirium following surgery. JAMA. 2012 Jul 4;308(1):73-81. doi: 10.1001/jama.2012.6857.
- Derived from this study: PubMed 35935775Fuest KE, Servatius A, Ulm B, Schaller SJ, Jungwirth B, Blobner M, Schmid S. Perioperative Hemodynamic Optimization in Patients at Risk for Delirium - A Randomized-Controlled Trial. Front Med (Lausanne). 2022 Jul 13;9:893459. doi: 10.3389/fmed.2022.893459. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Bettina Jungwirth, MD principal investigator
Klinik für Anaesthesiologie Technische Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PulsioflexTM Monitoring in people with Delirium, run by Technical University of Munich at 1 site in Germany.
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 2 inclusion and 6 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 8 Apr 2021. 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 Germany. 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?
Incidence of delirium until day 7 (CAM-Score and clinical diagnosis) (time frame: Before induction of anesthesia until 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01827501, which also lists 2 linked publications.
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 8 Apr 2021.