Postoperative Cognitive DysfunctionDelPOCDNCT03060174
Study of Prevention of Postoperative Delirum to Reduce Incidence of Postoperative Cognitive Dysfunction
A study testing monitoring and non-medical prophylaxis of delirium in people with Postoperative Cognitive Dysfunction and Postoperative Delirium, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Postoperative cognitive dysfunction describes a condition where cognitive functions such as attention, perception, concentration, learning, abstract thinking and problem solving are impaired postoperatively. These changes can be resolved after weeks and months, but in some cases may be permanent. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Postoperative Delirium
- What is being tested?
- monitoring and non-medical prophylaxis of delirium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 638 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to May 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 60 years
- Cardiac surgery (on-pump/off-pump, standard/minimal invasive)
- Written informed patient's consent
Who cannot join
- Non-German speaking or not their first language
- Illiteracy
- Mental disability
- Non-corrigible vision impairment
- Non-corrigible hearing impairment
- Illegal substance abuse (current or past history)
Show all 19Show fewer
- Alcohol abuse (current or past history)
- Chronic benzodiazepine use
- Psychosis (current or past history)
- Parkinson Disease
- Dementia
- Multiple sclerosis
- Epilepsy (current or past history)
- Cerebral tumor (current or past history)
- Apoplexy or intracranial bleeding (current or past history)
- Severe traumatic brain injury (current or past history)
- Severe liver disease (Child Pugh B, C, liver insufficiency)
- Severe kidney disease with dialysis
- Mini Mental Status Examination < 24 points
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf, Univ.-Prof. Dr. med. Alwin E. Goetz and Prof. Dr. med. Christian Zoellner
Hamburg, 20246
About this study
Official title: The Influence of Non-medication-based Prophylaxis of Postoperative Delirium on Postoperative Delirium and Cognitive Deficit
Postoperative cognitive dysfunction describes a condition where cognitive functions such as attention, perception, concentration, learning, abstract thinking and problem solving are impaired postoperatively. These changes can be resolved after weeks and months, but in some cases may be permanent.
The aetiology is multifactorial. One risk factor for developing POCD is the occurrence of postoperative delirium.
Read more
A total of 638 consecutive patients will be enrolled in the study. Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The cognitive function will be tested and compared to tests done before surgery. Postoperatively (from the day of operation until the 7th day and except of day 6) the grade of sedation; agitation; signs of delirium; pain; cardiac; respiratory; renal and infectious complications will be recorded.
As possible influencing factors, the investigators will document diagnosed depression; comorbidities; intraoperative blood loss; length of hospital stay; 1-year-mortality; number of operations/anaesthetics undergone after the initial operation.
Parameters that could trigger either depressive symptoms, neurocognitive dysfunction, anxiety, fatigue or lack of concentration will be recorded. These include: anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular filtration rate, cortisone therapy and adrenal cortical insufficiency.
Read the detailed description
The methods include a neuropsychological test battery: TAP 2.3 (attention), Trail Making Test (TMT )A+B (attention), Digit span (memory), (Visual Learning and Memory Test (VLMT) (memory), Regensburgerwortfluessigkeitstest/fluency (RWT) subtests (executive function), Mehrfach-Wortschatz-Intelligenztest/vocabulary (MWT-B) (premorbid IQ).
Other measures are Hospital Anxiety and Depression Scale (HADS-D) (depressive symptoms and anxiety), Mini Mental State Examination (MMSE) 2 (dementia), Confusion Assessment Method (CAM-ICU) (delirium), Richmond Agitation and Sedation Scale (RASS) (sedation and agitation), Numeric Rating Scale (NRS) (pain) and Short Form Health Survey (SF-12) (health related quality of life).
- Being tested
- monitoring and non-medical prophylaxis of delirium
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitoring and non-medical prophylaxis of deliriumOther
| Study group | Role | What they receive |
|---|---|---|
| monitoring and non-medical prophylaxis of delirium | Other | The treatment group will receive monitoring and prophylaxis of delirium. The study arm designed to prevent delirium incorporates reorientation (watches, calendar, family photos, use of hearing aids, glasses and dentures, cognitive stimulation (newspaper, magazines, radio, television), early mobilisation, early enteral nutrition, early removal of drains or catheters, normalizing sleep-awake-rhythm. Receives: Other: monitoring and non-medical prophylaxis of delirium |
| Standard | No intervention | The standard group will receive standard monitoring and standard treatment. The indication, choice and dosage of the medication used to treat delirium will be at the discretion of the ward doctor and will not be influenced by this study. The chosen medication as well as its dosage will be documented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative cognitive deficit (POCD)
measured by neuropsychological test battery, analysis
Measured: change from baseline in cognitive function at day 7, 3 months and 1 year after operation
Secondary outcomes (8)
incidence and severity of postoperative delirium
measured 3 times per day via CAM-ICU
Measured: from the day of operation until the 7th postoperative day
number of patients with cardiac complications
daily documentation of cardiac complications (central venous oxygen saturation, myocardial infarction, acute heart failure, others)
Measured: day of operation until 7th postoperative day
length of hospital stay
Measured: from day of admission until day of discharge, up to 24 weeks
mortality
Measured: 1 year
health related quality of life
Short Form Health Survey (SF-12)
Measured: 3 months, 1 year after operation
number of patients with respiratory complications
daily documentation of pulmonary complications (pneumonia, pulmonary oedema, others),
Measured: day of operation until 7th postoperative day
number of patients with renal complications
daily documentation of renal complications (creatinine, haemo(dia)filtration or haemodialysis)
Measured: day of operation until 7th postoperative day
number of patients with complications in the immunosystem
daily documentation of parameters mirroring the immune answer (C-reactive protein, leukocytes, procalcitonin)
Measured: day of operation until 7th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startMay 2014
- Primary completionMay 2018
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 638 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060174
- Sponsor's protocol ID
- PV4654
- Acronym
- DelPOCD
- Status last verified
- Oct 2021
- First submitted
- 16 Jun 2014
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Non-medication-based Prophylaxis of Postoperative Delirium on Postoperative Delirium and Cognitive Deficit
- ClinicalTrials.gov ID
- NCT03060174
- Acronym / sponsor ID
- DelPOCD / PV4654
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 638 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2018 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 23 Feb 2017 (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.
Postoperative cognitive dysfunction describes a condition where cognitive functions such as attention, perception, concentration, learning, abstract thinking and problem solving are impaired postoperatively. These changes can be resolved after weeks and months, but in some cases may be permanent.
The aetiology is multifactorial. One risk factor for developing POCD is the occurrence of postoperative delirium.
A total of 638 consecutive patients will be enrolled in the study. Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The cognitive function will be tested and compared to tests done before surgery. Postoperatively (from the day of operation until the 7th day and except of day 6) the grade of sedation; agitation; signs of delirium; pain; cardiac; respiratory; renal and infectious complications will be recorded.
As possible influencing factors, the investigators will document diagnosed depression; comorbidities; intraoperative blood loss; length of hospital stay; 1-year-mortality; number of operations/anaesthetics undergone after the initial operation.
Parameters that could trigger either depressive symptoms, neurocognitive dysfunction, anxiety, fatigue or lack of concentration will be recorded. These include: anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular filtration rate, cortisone therapy and adrenal cortical insufficiency.
Detailed description
The methods include a neuropsychological test battery: TAP 2.3 (attention), Trail Making Test (TMT )A+B (attention), Digit span (memory), (Visual Learning and Memory Test (VLMT) (memory), Regensburgerwortfluessigkeitstest/fluency (RWT) subtests (executive function), Mehrfach-Wortschatz-Intelligenztest/vocabulary (MWT-B) (premorbid IQ).
Other measures are Hospital Anxiety and Depression Scale (HADS-D) (depressive symptoms and anxiety), Mini Mental State Examination (MMSE) 2 (dementia), Confusion Assessment Method (CAM-ICU) (delirium), Richmond Agitation and Sedation Scale (RASS) (sedation and agitation), Numeric Rating Scale (NRS) (pain) and Short Form Health Survey (SF-12) (health related quality of life).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monitoring and non-medical prophylaxis of delirium | Other | Other: monitoring and non-medical prophylaxis of deliriumThe treatment group will receive monitoring and prophylaxis of delirium. The study arm designed to prevent delirium incorporates reorientation (watches, calendar, family photos, use of hearing aids, glasses and dentures, cognitive stimulation (newspaper, magazines, radio, television), early mobilisation, early enteral nutrition, early removal of drains or catheters, normalizing sleep-awake-rhythm. |
| Standard | No intervention | –The standard group will receive standard monitoring and standard treatment. The indication, choice and dosage of the medication used to treat delirium will be at the discretion of the ward doctor and will not be influenced by this study. The chosen medication as well as its dosage will be documented. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 60 years
- Cardiac surgery (on-pump/off-pump, standard/minimal invasive)
- Written informed patient's consent
Key exclusion criteria (19 listed)
- Non-German speaking or not their first language
- Illiteracy
- Mental disability
- Non-corrigible vision impairment
- Non-corrigible hearing impairment
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 |
|---|---|---|
| monitoring and non-medical prophylaxis of delirium | Other | monitoring and non-medical prophylaxis of delirium |
Primary outcome
postoperative cognitive deficit (POCD)
Time frame: change from baseline in cognitive function at day 7, 3 months and 1 year after operation
measured by neuropsychological test battery, analysis
8 secondary outcomes
incidence and severity of postoperative delirium
Time frame: from the day of operation until the 7th postoperative day
number of patients with cardiac complications
Time frame: day of operation until 7th postoperative day
length of hospital stay
Time frame: from day of admission until day of discharge, up to 24 weeks
mortality
Time frame: 1 year
health related quality of life
Time frame: 3 months, 1 year after operation
number of patients with respiratory complications
Time frame: day of operation until 7th postoperative day
number of patients with renal complications
Time frame: day of operation until 7th postoperative day
number of patients with complications in the immunosystem
Time frame: day of operation until 7th postoperative day
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 26 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monitoring and non-medical prophylaxis of delirium in people with Postoperative Cognitive Dysfunction and Postoperative Delirium, run by Universitätsklinikum Hamburg-Eppendorf 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 3 inclusion and 19 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 26 Oct 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?
postoperative cognitive deficit (POCD) (time frame: change from baseline in cognitive function at day 7, 3 months and 1 year after operation). 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 26 Oct 2021.