Postoperative DeliriumNCT06473324
Association Between Preoperative Hyperglycemia and Postoperative Delirium in Geriatric Hip Fracture Patients
An observational study of Postoperative Delirium and Hip Fractures, run by Wenbo Ding at 1 site in China.
Trial summary
This retrospective study aims to collect electronic medical record data from Dandong central hospital spanning from January 2013 to November 2023. The collected data does not contain any personally identifiable information or breach privacy. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Postoperative Delirium, Hip Fractures, Hyperglycemia
- How many people
- 2,031 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2023to 3 Jan 2024
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 2,031 electronic medical records were gathered. Following stringent inclusion and exclusion criteria, a retrospective cohort study was conducted on 1,440 patients with hip fracture. Among them, 783 patients (54.4%) exhibited preoperative persistent hyperglycemia (serum glucose levels ≥ 6.1 mmol/L on multiple occasions), while 275 patients (19.1%) experienced postoperative delirium. The average age of the included geriatric hip fracture patients was 74.7 ± 9.8 years, with males comprising 39.7% of the sample.
Who may be able to join
- 1) Patients who have undergone surgical treatment for hip fractures.
Who cannot join
- Multiple or pathological hip fractures.
- Emergent surgery.
- Age below 60 years.
- Incomplete electronic medical records or preoperative blood glucose levels were assessed fewer than two times.
- Presence of neurological and psychiatric disorders, except dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Preoperative Persistent Hyperglycemia and Postoperative Delirium in Geriatric Hip Fracture Patients
This retrospective study aims to collect electronic medical record data from Dandong central hospital spanning from January 2013 to November 2023. The collected data does not contain any personally identifiable information or breach privacy. Additionally, this study design does not involve active intervention measures or patient recruitment. The research aims to investigate the correlation between preoperative blood glucose levels in elderly hip fracture patients and postoperative delirium.
Read the detailed description
A retrospective observational study is planned to explore specific phenomena or associations using electronic medical record data. The collected data does not contain any personally identifiable information or compromise privacy. Additionally, this study design does not involve active intervention measures or patient recruitment. The study data is sourced from the electronic medical record system of hospitalized patients and has received approval from the hospital's research center, with ongoing supervision by the hospital's ethics committee. The study aims to investigate the correlation between preoperative blood glucose levels in hip fracture patients and postoperative complications.
The retrospective study aims to collect electronic medical record data spanning from January 2013 to November 2023. The data collection process is consistently monitored and verified by the hospital's ethics committee. Throughout the study, adherence to the ethical principles outlined in the 1964 Helsinki Declaration is ensured, and institutional review board (IRB) approval has been obtained for all aspects of the research.
The study aims to provide valuable evidence-based medicine for clinical practitioners by examining the relationship between preoperative persistent hyperglycemia in elderly hip fracture patients and postoperative delirium. Furthermore, it seeks to offer clinical insights for early identification and intervention management of high-risk postoperative delirium patients (POD).
- Conditions
- Postoperative Delirium, Hip Fractures, Hyperglycemia
- Medical subject headings
- Emergence Delirium, Hip Fractures, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hyperglycaemia group | Blood glucose level ≥ 6.1 mmol/L | |
| hypoglycaemic group | Blood glucose level < 6.1 mmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Postoperative Delirium
Postoperative Delirium (POD) manifests as acute cognitive dysfunction and consciousness disorder, characterized by changes in attention or consciousness that cannot be attributed to pre-existing cognitive impairments. Typical symptoms include hallucinations, delusions, agitated behavior, disordered speech, decreased attention, confusion, unclear consciousness, and disrupted sleep-wake cycles. Moreover, POD typically occurs within the first five days after surgery, particularly within the initial 48 hours, and exhibits significant fluctuations.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start21 Nov 2023
- Primary completion1 Jan 2024
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,031 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenbo Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wenbo Ding, Dandong Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473324
- Sponsor's protocol ID
- DDZX-20231121
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang W, Zhang Y, Yao W, Tang W, Li Y, Sun H, Ding W. Association between preoperative persistent hyperglycemia and postoperative delirium in geriatric hip fracture patients. BMC Geriatr. 2024 Jul 8;24(1):585. doi: 10.1186/s12877-024-05192-x.
PubMed 38977983
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Preoperative Persistent Hyperglycemia and Postoperative Delirium in Geriatric Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT06473324
- Acronym / sponsor ID
- DDZX-20231121
- Conditions
- Postoperative Delirium, Hip Fractures, Hyperglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,031 participants (actual)
- Lead sponsor
- Wenbo DingUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 25 Jun 2024 (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.
This retrospective study aims to collect electronic medical record data from Dandong central hospital spanning from January 2013 to November 2023. The collected data does not contain any personally identifiable information or breach privacy. Additionally, this study design does not involve active intervention measures or patient recruitment. The research aims to investigate the correlation between preoperative blood glucose levels in elderly hip fracture patients and postoperative delirium.
Detailed description
A retrospective observational study is planned to explore specific phenomena or associations using electronic medical record data. The collected data does not contain any personally identifiable information or compromise privacy. Additionally, this study design does not involve active intervention measures or patient recruitment. The study data is sourced from the electronic medical record system of hospitalized patients and has received approval from the hospital's research center, with ongoing supervision by the hospital's ethics committee. The study aims to investigate the correlation between preoperative blood glucose levels in hip fracture patients and postoperative complications.
The retrospective study aims to collect electronic medical record data spanning from January 2013 to November 2023. The data collection process is consistently monitored and verified by the hospital's ethics committee. Throughout the study, adherence to the ethical principles outlined in the 1964 Helsinki Declaration is ensured, and institutional review board (IRB) approval has been obtained for all aspects of the research.
The study aims to provide valuable evidence-based medicine for clinical practitioners by examining the relationship between preoperative persistent hyperglycemia in elderly hip fracture patients and postoperative delirium. Furthermore, it seeks to offer clinical insights for early identification and intervention management of high-risk postoperative delirium patients (POD).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperglycaemia group | – | –Blood glucose level ≥ 6.1 mmol/L |
| hypoglycaemic group | – | –Blood glucose level < 6.1 mmol/L |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 2,031 electronic medical records were gathered. Following stringent inclusion and exclusion criteria, a retrospective cohort study was conducted on 1,440 patients with hip fracture. Among them, 783 patients (54.4%) exhibited preoperative persistent hyperglycemia (serum glucose levels ≥ 6.1 mmol/L on multiple occasions), while 275 patients (19.1%) experienced postoperative delirium. The average age of the included geriatric hip fracture patients was 74.7 ± 9.8 years, with males comprising 39.7% of the sample.
Key inclusion criteria (1 listed)
- 1) Patients who have undergone surgical treatment for hip fractures.
Key exclusion criteria (5 listed)
- Multiple or pathological hip fractures.
- Emergent surgery.
- Age below 60 years.
- Incomplete electronic medical records or preoperative blood glucose levels were assessed fewer than two times.
- Presence of neurological and psychiatric disorders, except dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Postoperative Delirium
Time frame: up to 2 months
Postoperative Delirium (POD) manifests as acute cognitive dysfunction and consciousness disorder, characterized by changes in attention or consciousness that cannot be attributed to pre-existing cognitive impairments. Typical symptoms include hallucinations, delusions, agitated behavior, disordered speech, decreased attention, confusion, unclear consciousness, and disrupted sleep-wake cycles. Moreover, POD typically occurs within the first five days after surgery, particularly within the initial 48 hours, and exhibits significant fluctuations.
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 25 Jun 2024.
- Derived from this study: PubMed 38977983Wang W, Zhang Y, Yao W, Tang W, Li Y, Sun H, Ding W. Association between preoperative persistent hyperglycemia and postoperative delirium in geriatric hip fracture patients. BMC Geriatr. 2024 Jul 8;24(1):585. doi: 10.1186/s12877-024-05192-x.
- 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.
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?
An observational study of Postoperative Delirium and Hip Fractures, run by Wenbo Ding at 1 site in China.
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: finished, as of the sponsor's last update on 25 Jun 2024. 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 China. 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?
Number of Participants with Postoperative Delirium (time frame: up to 2 months). 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 NCT06473324, which also lists 1 linked publication.
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 25 Jun 2024.