DeliriummRNAOrthoNCT02323984
Postoperative Delirium in Hip Arthroplasty Patients
An observational study of Delirium and Postoperative Complications, run by Ohio State University at 1 site in United States.
Trial summary
Identification of specific circulating microRNAs and microemboli formation (diagnosed by TC Doppler) in both delirious groups and nondelirious group will be our primary target. Delirium assessment through standardized questionnaires will be done at baseline (day of the surgery - pre operatory), immediately after… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Delirium, Postoperative Complications
- What is being tested?
- miRNA Testing, Microemboli Monitoring, Delirium Assessment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2016
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects schedule to undergo hip arthroplasty surgery
Who may be able to join
- Male or female, between 30 and 80 years of age
- ASA I , II or III
- Capable and willing to consent
- Participants literate in English language
Who cannot join
- ASA IV or V
- Patients with severe visual or auditory disorder
- Illiteracy
- Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
- Dementia of Alzheimer's type
- Parkinson disease
- Multiple Sclerosis (MS)
- Vascular dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Postoperative Delirium in Patients Undergoing Hip Arthroplasty
Identification of specific circulating microRNAs and microemboli formation (diagnosed by TC Doppler) in both delirious groups and nondelirious group will be our primary target. Delirium assessment through standardized questionnaires will be done at baseline (day of the surgery - pre operatory), immediately after surgery (in post anesthesia care unit) and then every 12 hours in Day 1 and Day2 after surgery. The investigators will use linear mixed models to describe the change patterns overtime, and compare differences at each time point. Inflammatory biomarkers will be explored overtime as well. The investigators will also explore age effect on cognitive function - cognitive reserve - based on the score of the cognitive test administered at baseline.
Read the detailed description
Specific circulating microRNA's have been identified in patients with neurological diseases or deficits, and specifically those with neurodegenerative conditions. Furthermore, available evidence primarily in pre-clinical / animal models supports the hypothesis that post-surgical/anesthesia - induced neuroinflammation leads to post-operative cognitive decline or dysfunction. The investigators hypothesize that specific circulating microRNA's involved in the pro-inflammatory response to surgery/anesthesia are a suitable biomarker of Delirium and/or POCD in surgical hip-arthroplasty patients. However, it is also possible that microamboli during the surgical procedure could contribute to these neurologic outcomes. Therefore, in addition to analyzing microRNA levels (our primary target), the investigators propose to monitor cerebral vascular flow during the surgery to possibly identify microambolic events using Transcranial Doppler. Overall, our overarching goal is to identify novel early clinical indicators of cognitive dysfunction (e.g. Delirium and POCD).
The study will include preoperative-postoperative trajectory as well as the value of using subjects as self-controls with appropriate longitudinal analyses of cognition.
There are many factors that are potential confounders in relation to cognitive decline and incident dementia.
There are key characteristics and events:
- illnesses requiring hospitalization, that could potentially accelerate cognitive decline or worsen clinical dementia rating
- which anesthetic agents are administered for the surgical procedure
- intra-operative adverse events (anesthesia/surgery related, cerebral hypoxia, hypotension/hypertension, blood loss)
- patient factors (age, education, comorbidity)
- physiologic factors (inflammation,micro-embolization, blood-brain barrier function);
- perioperative factors (medications, sleep, complications)
- postoperative factors (rehabilitation, depression, social support)
- Conditions
- Delirium, Postoperative Complications
- Being tested
- miRNA Testing, Microemboli Monitoring, Delirium Assessment
- Medical subject headings
- Delirium, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRNA Testing, Microemboli Monitoring, Delirium AssessmentOther
Delirium assessment questionnaire and blood testing for miRNA will be done for all patients postoperatively, as well as BIS monitoring during surgery. The three arms of the study indicate the allocation of each patient based on their delirium presentation (hypoactive, hyperactive, or none).
| Study group | Role | What they receive |
|---|---|---|
| Hypoactive Delirium - Delirious | Hypoactive delirious patients presenting with lethargy and sedation and are slow to respond to questions and demonstrate little spontaneous movement. miRNA Testing, Microemboli Monitoring, Delirium Assessment will be performed Receives: Other: miRNA Testing, Microemboli Monitoring, Delirium Assessment | |
| Hyperactive Delirium - Delirious | Hyperactive delirious patients presenting with restlessness, agitation, hyper vigilance, and occaionally hallucinations. miRNA Testing, Microemboli Monitoring, Delirium Assessment will be performed Receives: Other: miRNA Testing, Microemboli Monitoring, Delirium Assessment | |
| No Delirium - Nondelirious | Patients not presenting any symptoms of hypoactive or hyperactive postoperative delirium. miRNA Testing, Microemboli Monitoring, Delirium Assessment will be performed Receives: Other: miRNA Testing, Microemboli Monitoring, Delirium Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of specific circulating microRNAs in post operative delirium patients
Identification of specific circulating microRNAs and microemboli formation (diagnosed by TC Doppler) in both delirious groups and nondelirious group will be our primary target. Our overarching goal is to identify novel early clinical indicators of cognitive dysfunction (e.g. Delirium and POCD)
Measured: Baseline, perioperatively and during post operative hospitalization (Day 1 and Day 2 post surgery)
Secondary outcomes (1)
Age effects on cognitive function (cognitive reserve)
We will explore age effect on cognitive function (cognitive reserve), based on the baselin cognitive assessment score.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionMar 2016
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 Ohio State UniversityThe 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicoleta Stoicea, Ohio State University
- Investigators
- Fievos L Christofi, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323984
- Sponsor's protocol ID
- 2013H0291
- Acronym
- mRNAOrtho
- Status last verified
- Jan 2017
- First submitted
- 16 Dec 2014
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Delirium in Patients Undergoing Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02323984
- Acronym / sponsor ID
- mRNAOrtho / 2013H0291
- Conditions
- Delirium, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Dec 2014 (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.
Identification of specific circulating microRNAs and microemboli formation (diagnosed by TC Doppler) in both delirious groups and nondelirious group will be our primary target. Delirium assessment through standardized questionnaires will be done at baseline (day of the surgery - pre operatory), immediately after surgery (in post anesthesia care unit) and then every 12 hours in Day 1 and Day2 after surgery. The investigators will use linear mixed models to describe the change patterns overtime, and compare differences at each time point. Inflammatory biomarkers will be explored overtime as well. The investigators will also explore age effect on cognitive function - cognitive reserve - based on the score of the cognitive test administered at baseline.
Detailed description
Specific circulating microRNA's have been identified in patients with neurological diseases or deficits, and specifically those with neurodegenerative conditions. Furthermore, available evidence primarily in pre-clinical / animal models supports the hypothesis that post-surgical/anesthesia - induced neuroinflammation leads to post-operative cognitive decline or dysfunction. The investigators hypothesize that specific circulating microRNA's involved in the pro-inflammatory response to surgery/anesthesia are a suitable biomarker of Delirium and/or POCD in surgical hip-arthroplasty patients. However, it is also possible that microamboli during the surgical procedure could contribute to these neurologic outcomes. Therefore, in addition to analyzing microRNA levels (our primary target), the investigators propose to monitor cerebral vascular flow during the surgery to possibly identify microambolic events using Transcranial Doppler. Overall, our overarching goal is to identify novel early clinical indicators of cognitive dysfunction (e.g. Delirium and POCD).
The study will include preoperative-postoperative trajectory as well as the value of using subjects as self-controls with appropriate longitudinal analyses of cognition.
There are many factors that are potential confounders in relation to cognitive decline and incident dementia.
There are key characteristics and events:
- illnesses requiring hospitalization, that could potentially accelerate cognitive decline or worsen clinical dementia rating
- which anesthetic agents are administered for the surgical procedure
- intra-operative adverse events (anesthesia/surgery related, cerebral hypoxia, hypotension/hypertension, blood loss)
- patient factors (age, education, comorbidity)
- physiologic factors (inflammation,micro-embolization, blood-brain barrier function);
- perioperative factors (medications, sleep, complications)
- postoperative factors (rehabilitation, depression, social support)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypoactive Delirium - Delirious | – | Other: miRNA Testing, Microemboli Monitoring, Delirium AssessmentHypoactive delirious patients presenting with lethargy and sedation and are slow to respond to questions and demonstrate little spontaneous movement. miRNA Testing, Microemboli Monitoring, Delirium Assessment will be performed |
| Hyperactive Delirium - Delirious | – | Other: miRNA Testing, Microemboli Monitoring, Delirium AssessmentHyperactive delirious patients presenting with restlessness, agitation, hyper vigilance, and occaionally hallucinations. miRNA Testing, Microemboli Monitoring, Delirium Assessment will be performed |
| No Delirium - Nondelirious | – | Other: miRNA Testing, Microemboli Monitoring, Delirium AssessmentPatients not presenting any symptoms of hypoactive or hyperactive postoperative delirium. miRNA Testing, Microemboli Monitoring, Delirium Assessment will be performed |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects schedule to undergo hip arthroplasty surgery
Key inclusion criteria (4 listed)
- Male or female, between 30 and 80 years of age
- ASA I , II or III
- Capable and willing to consent
- Participants literate in English language
Key exclusion criteria (8 listed)
- ASA IV or V
- Patients with severe visual or auditory disorder
- Illiteracy
- Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
- Dementia of Alzheimer's type
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 |
|---|---|---|
| miRNA Testing, Microemboli Monitoring, Delirium AssessmentDelirium assessment questionnaire and blood testing for miRNA will be done for all patients postoperatively, as well as BIS monitoring during surgery. The three arms of the study indicate the allocation of each patient based on their delirium presentation (hypoactive, hyperactive, or none). | Other | Hyperactive Delirium - Delirious, Hypoactive Delirium - Delirious, No Delirium - Nondelirious |
Primary outcome
Identification of specific circulating microRNAs in post operative delirium patients
Time frame: Baseline, perioperatively and during post operative hospitalization (Day 1 and Day 2 post surgery)
Identification of specific circulating microRNAs and microemboli formation (diagnosed by TC Doppler) in both delirious groups and nondelirious group will be our primary target. Our overarching goal is to identify novel early clinical indicators of cognitive dysfunction (e.g. Delirium and POCD)
1 secondary outcome
Age effects on cognitive function (cognitive reserve)
Time frame: Baseline
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 20 Jan 2017.
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
Not yet recruiting
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
Not yet recruiting
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.
Fievos L Christofi, PhD principal investigator
Ohio State University
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 Postoperative Complications, run by Ohio State University at 1 site in United States.
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 4 inclusion and 8 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 20 Jan 2017. 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 United States. 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?
Identification of specific circulating microRNAs in post operative delirium patients (time frame: Baseline, perioperatively and during post operative hospitalization (Day 1 and Day 2 post surgery)). 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 20 Jan 2017.