Postoperative DeliriumNCT02817386
Study of Postoperative Delirium in Elderly People After Orthopedic Surgery
An observational study of Postoperative Delirium, run by Zhongnan Hospital.
Trial summary
The purpose of this study is to investigate the possible relationship of microRNA and postoperative delirium. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- interview
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Feb 2016
- How long will I take part?
- 2 Days
- 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
- Healthy volunteers accepted
- Older adult
Study population: A total of 60 adults who were scheduled to have elective total hip or knee replacement surgery at the Zhongnan Hospital were asked to participate in this study.
Who may be able to join
- 65 years old or older
- candidates for spinal anesthesia
- Non language communication barriers
Who cannot join
- past medical history of neurological and psychiatric diseases including AD, other forms of dementia, stroke, or psychosis;
- severe visual or hearing impairment;
- unwillingness to comply with the protocol or procedures.
About this study
Official title: microRNA and Delirium After Hip and Knee Fracture
The purpose of this study is to investigate the possible relationship of microRNA and postoperative delirium.
Read the detailed description
Postoperative delirium is one of the most common postoperative complications in elderly patients.It has been shown that postoperative delirium has independent adverse effects on short and long-term mortality and morbidity, including poor functional recovery, postoperative cognitive dysfunction, deterioration in quality of life, and increased costs. However, at the present time, postoperative delirium is a clinical phenomenon, and its neuropathogenesis remains unknown. This gap in knowledge has become a barrier that limits further studies, including the development of potential interventions for postoperative delirium.
- Conditions
- Postoperative Delirium
- Being tested
- interview
- Keywords
- postoperative delirium, microRNA
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
Trained clinical research assistants interviewed the patients on the first and second day post surgery. The interview included the Confusion Assessment Method (CAM) and MDAS. CAM is a diagnostic algorithm used to determine the presence or absence of delirium.
| Study group | Role | What they receive |
|---|---|---|
| POD and Non-POD; | Trained clinical research assistants interviewed the patients on the first and second day post surgery. The assessment of post deliriu (POD) was performed once per day between 8:00 AM to 10:00 AM. Patient notes were not reviewed for episodes of delirium which could occur outside the time of assessment. The clinical research assistants who performed the delirium assessments in this study had good training and went through quality control procedures. We used state-of-the-art delirium detection methods, which tend to report a higher incidence of delirium. The interview included the Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS). Receives: Other: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of microRNA in cerebrospinal fluid and serum
All of the participants had spinal anesthesia for the scheduled surgery. Two milliliter of CSF was collected from a spinal needle by anesthesiologists during the spinal anesthesia before the administration of the local anesthetic. Blood samples were collected from patients prior to spinal anesthesia.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionFeb 2016
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 Postoperative 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mian Peng,MD, Zhongnan Hospital
- Investigators
- Mian Peng, MD, Study director, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817386
- Sponsor's protocol ID
- 2015002
- Status last verified
- Feb 2017
- First submitted
- 22 Jun 2016
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Xie Z, Swain CA, Ward SA, Zheng H, Dong Y, Sunder N, Burke DW, Escobar D, Zhang Y, Marcantonio ER. Preoperative cerebrospinal fluid beta-Amyloid/Tau ratio and postoperative delirium. Ann Clin Transl Neurol. 2014 May 1;1(5):319-328. doi: 10.1002/acn3.58.
PubMed 24860840Dong R, Sun L, Lu Y, Yang X, Peng M, Zhang Z. NeurimmiRs and Postoperative Delirium in Elderly Patients Undergoing Total Hip/Knee Replacement: A Pilot Study. Front Aging Neurosci. 2017 Jun 23;9:200. doi: 10.3389/fnagi.2017.00200. eCollection 2017.
PubMed 28690539
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- microRNA and Delirium After Hip and Knee Fracture
- ClinicalTrials.gov ID
- NCT02817386
- Acronym / sponsor ID
- 2015002
- Conditions
- Postoperative Delirium
- Keywords
- postoperative delirium, microRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 29 Jun 2016 (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 investigate the possible relationship of microRNA and postoperative delirium.
Detailed description
Postoperative delirium is one of the most common postoperative complications in elderly patients.It has been shown that postoperative delirium has independent adverse effects on short and long-term mortality and morbidity, including poor functional recovery, postoperative cognitive dysfunction, deterioration in quality of life, and increased costs. However, at the present time, postoperative delirium is a clinical phenomenon, and its neuropathogenesis remains unknown. This gap in knowledge has become a barrier that limits further studies, including the development of potential interventions for postoperative delirium.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POD and Non-POD; | – | Other: interviewTrained clinical research assistants interviewed the patients on the first and second day post surgery. The assessment of post deliriu (POD) was performed once per day between 8:00 AM to 10:00 AM. Patient notes were not reviewed for episodes of delirium which could occur outside the time of assessment. The clinical research assistants who performed the delirium assessments in this study had good training and went through quality control procedures. We used state-of-the-art delirium detection methods, which tend to report a higher incidence of delirium. The interview included the Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- A total of 60 adults who were scheduled to have elective total hip or knee replacement surgery at the Zhongnan Hospital were asked to participate in this study.
Key inclusion criteria (3 listed)
- 65 years old or older
- candidates for spinal anesthesia
- Non language communication barriers
Key exclusion criteria (3 listed)
- past medical history of neurological and psychiatric diseases including AD, other forms of dementia, stroke, or psychosis;
- severe visual or hearing impairment;
- unwillingness to comply with the protocol or procedures.
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 |
|---|---|---|
| interviewTrained clinical research assistants interviewed the patients on the first and second day post surgery. The interview included the Confusion Assessment Method (CAM) and MDAS. CAM is a diagnostic algorithm used to determine the presence or absence of delirium. | Other | POD and Non-POD; |
Primary outcome
The level of microRNA in cerebrospinal fluid and serum
Time frame: through study completion, an average of 1 year
All of the participants had spinal anesthesia for the scheduled surgery. Two milliliter of CSF was collected from a spinal needle by anesthesiologists during the spinal anesthesia before the administration of the local anesthetic. Blood samples were collected from patients prior to spinal anesthesia.
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 24 Feb 2017.
- Background: PubMed 24860840Xie Z, Swain CA, Ward SA, Zheng H, Dong Y, Sunder N, Burke DW, Escobar D, Zhang Y, Marcantonio ER. Preoperative cerebrospinal fluid beta-Amyloid/Tau ratio and postoperative delirium. Ann Clin Transl Neurol. 2014 May 1;1(5):319-328. doi: 10.1002/acn3.58.
- Derived from this study: PubMed 28690539Dong R, Sun L, Lu Y, Yang X, Peng M, Zhang Z. NeurimmiRs and Postoperative Delirium in Elderly Patients Undergoing Total Hip/Knee Replacement: A Pilot Study. Front Aging Neurosci. 2017 Jun 23;9:200. doi: 10.3389/fnagi.2017.00200. eCollection 2017.
- Individual participant dataSharing planned: No
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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.
Mian Peng, MD study director
Zhongnan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Zhongnan Hospital.
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 3 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 level of microRNA in cerebrospinal fluid and serum (time frame: through study completion, an average of 1 year). 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 NCT02817386, 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 24 Feb 2017.