Postoperative DeliriumNCT07297017
Naples Prognostic Score for Predicting Postoperative Delirium
An observational study of Postoperative Delirium, run by South Valley University at 1 site in Egypt.
Trial summary
Naples Prognostic Score (NPS) originally developed to predict outcomes in inflammatory and malignant conditions; we asked if it can effectively predict postoperative delirium (POD) in elderly patients undergoing hip surgery? NPS integrate markers such as albumin, neutrophil-to-lymphocyte ratio, and… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Delirium
- How many people
- 168 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: elderly patients undergoing Hip fracture surgery
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Qena University
Qina, Qena Governorate, 83511
ZAINAB MOSTAFA, 01009071365, zeinab5aton@gmail.com
About this study
Official title: Naples Prognostic Score for Predicting Postoperative Delirium in the Elderly Undergoing Hip Fracture Surgeries
Naples Prognostic Score (NPS) originally developed to predict outcomes in inflammatory and malignant conditions; we asked if it can effectively predict postoperative delirium (POD) in elderly patients undergoing hip surgery? NPS integrate markers such as albumin, neutrophil-to-lymphocyte ratio, and lymphocyte-to-monocyte ratio-all of which have been linked to adverse postoperative outcomes including POD.
Read the 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
- Conditions
- Postoperative Delirium
- Keywords
- POD, elderly, geriatric, NPS
- Medical subject headings
- Emergence Delirium
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of postoperative delirium
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.
Measured: on arrival to PACU, on postoperative day 1, 2, 3, 5, 7.
Secondary outcomes (1)
Length of hospital stay
Determine the duration of hospital stay for geriatric hip fracture patients in our hospital.
Measured: Directly before patients' discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start10 Jan 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gaber Ahmed, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297017
- Sponsor's protocol ID
- ِAIP003-7
- Status last verified
- May 2026
- First submitted
- 25 Nov 2025
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naples Prognostic Score for Predicting Postoperative Delirium in the Elderly Undergoing Hip Fracture Surgeries
- ClinicalTrials.gov ID
- NCT07297017
- Acronym / sponsor ID
- ِAIP003-7
- Conditions
- Postoperative Delirium
- Keywords
- POD, elderly, geriatric, NPS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Dec 2025 (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.
Naples Prognostic Score (NPS) originally developed to predict outcomes in inflammatory and malignant conditions; we asked if it can effectively predict postoperative delirium (POD) in elderly patients undergoing hip surgery? NPS integrate markers such as albumin, neutrophil-to-lymphocyte ratio, and lymphocyte-to-monocyte ratio-all of which have been linked to adverse postoperative outcomes including POD.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elderly patients undergoing Hip fracture surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
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
Assessment of postoperative delirium
Time frame: on arrival to PACU, on postoperative day 1, 2, 3, 5, 7.
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.
1 secondary outcome
Length of hospital stay
Time frame: Directly before patients' discharge from hospital
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- 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.
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, run by South Valley University at 1 site in Egypt.
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 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeinab M Sayed, MD (+201009071365, zeinab5aton@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of postoperative delirium (time frame: on arrival to PACU, on postoperative day 1, 2, 3, 5, 7.). 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 14 May 2026.