- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07297017
Naples Prognostic Score for Predicting Postoperative Delirium
Naples Prognostic Score for Predicting Postoperative Delirium in the Elderly Undergoing Hip Fracture Surgeries
Study Overview
Status
Conditions
Detailed Description
Delirium is a state of acute cerebral dysfunction that manifests as fluctuations in mental status. It is a common problem among all patients admitted to the hospital and has the potential to significantly alter patients' clinical outcomes. There are many risk factors that predispose patients to delirium including age, frailty, and preexisting comorbid conditions, as well as risk factors unique to the perioperative period, such as severity of concurrent illness, type of operation, and ICU admission after surgery (3). Postoperative delirium (POD) should be of paramount importance to providers, as multiple studies in perioperative patients have found significant associations between development of delirium within the first few days of surgery and increased length of stay, higher cost of care, increased hospital readmission rates, higher likelihood of discharge to institution, prolonged cognitive impairment and dementia, and increased mortality (4) (5) . POD occurs commonly but underdiagnosed, and is associated with worse patient outcomes.
Postoperative delirium known as a common and serious complication in elderly surgical patients, particularly after orthopedic surgeries, incidences ranging typically from 5%% up to 48%, with some reports citing rates as high as 70-80% in high-risk geriatric populations (12) . Recent literature showed a strong association between levels of nutritional parameters such as serum albumin (Alb) and lipids and an increased risk of POD (7).However, it is important to note that the prognostic power of a single marker of inflammation or nutritional index might be influenced by variations in physical conditions and the surrounding environment (8). Accordingly, the concept of using a compound indicator of nutrition state and inflammation, known as NPS, presented a novel idea for predicting POD Over the last few years, the NPS was widely used to evaluate the prognosis of cancer patients. Miyamoto et al. pointed out that the NPS was a valuable predictor for postoperative harmful outcomes in patients who underwent colorectal cancer ( CRC) and gastric cancer (GC) surgeries (9).
Because NPS combine inflammatory and nutritional indices, they may provide a more robust and easily measurable means of identifying patients at risk for POD. A preoperative tool based on these scores could enable early intervention, tailored perioperative care, and improved outcomes in this vulnerable population
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zeinab M Sayed, MD
- Phone Number: +201009071365
- Email: zeinab5aton@gmail.com
Study Locations
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Qena Governorate
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Qina, Qena Governorate, Egypt, 83511
- Recruiting
- Qena University
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Contact:
- ZAINAB MOSTAFA
- Phone Number: 01009071365
- Email: zeinab5aton@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The elderly age≥60 years
- American Society of Anesthesiologists (ASA) classification II∼IV
- Patients undergoing hip fracture surgery
- Patients who had a complete blood sample were taken preoperatively
Exclusion Criteria:
- Patient refused to participate and consent
- Patients with a history of mild cognitive impairment (MCI), dementia, and delirium
- Ptients with known preoperative infections (pulmonary infection, urinary infection, and sepsis).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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hip group
patients undergoing hip surgeries will be screened for delirium in the Post-Anesthesia Care Unit (PACU) on arrival, and once daily for the first 3 postoperative days (postoperative days 1 to 3), and on postoperative days 5 and 7.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of postoperative delirium
Time Frame: on arrival to PACU, on postoperative day 1, 2, 3, 5, 7.
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Assessment of postoperative deliurim will be done once daily by using an established screening instrument (The Confusion Assessment Method (CAM)).
A positive CAM requires both (1) Acute onset & fluctuating course AND (2) Inattention, plus (3) Disorganized thinking OR (4) Altered level of consciousness.
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on arrival to PACU, on postoperative day 1, 2, 3, 5, 7.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Length of hospital stay
Time Frame: Directly before patients' discharge from hospital
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Determine the duration of hospital stay for geriatric hip fracture patients in our hospital.
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Directly before patients' discharge from hospital
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ِAIP003-7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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