Salivary Alpha-amylaseNCT06242275
Perioperative Salivary Alpha-amylase as a Predictor of Delirium After Lower Extremity Vascular Bypass Surgery
An observational study of Salivary Alpha-amylase and Delirium, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the role of salivary Alpha-amylase as a predictor biomarker of POD in elderly patients undergoing limb bypass surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Salivary Alpha-amylase, Delirium, Lower Extremity
- What is being tested?
- Salivary Alpha-amylase
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2024to 19 Jun 2025
- 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
- No healthy volunteers
- Older adult
Study population: 60 patients aged ≥ 65 years, both sexes, American Society of Anesthesiologists (ASA) physical status III, undergoing lower extremity vascular surgery under general anesthesia.
Who may be able to join
- Age ≥ 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status III.
- Undergoing lower extremity vascular surgery under general anesthesia.
Who cannot join
- Patients who used any medication that could affect salivary glands (such as antihypertensive, antidepressants or antipsychotic drugs).
- Inability to communicate.
- History of psychiatric diseases or previous stroke
- Previous history of pod.
- Those with smoking and drinking habits.
- Pregnant female.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the role of salivary Alpha-amylase as a predictor biomarker of POD in elderly patients undergoing limb bypass surgery.
Read the detailed description
Delirium is a neuropsychiatric syndrome that is characterized by the sudden onset of altered awareness, decreased ability to maintain attention, and disorders of the mental process. The pathophysiology of Postoperative delirium (POD) is related to postoperative neuroinflammation.
Biomarkers not only indicate a certain pathological state, but also provide information about disease activity and progression. Although several biomarkers are reported to predict POD, biomarkers with high sensitivity and specificity are still lacking.
Biochemical parameters associated with complement cascade (C3a, C3, C5a) and inflammatory response (IL-17A, IL-33, E-selectin, MMP9) were involved in neurocognitive regulation.
Salivary alpha amylase (SAA) enzyme is one of the most important enzyme compositions in the saliva that accounts for 40% to 50% of the total salivary proteins, and most of it is secreted from the parotid gland. SAA is locally produced by the highly differentiated epithelial acinar cells of the exocrine salivary glands, mostly of the parotid glands and plays an important role in carbohydrate hydrolysis.
- Being tested
- Salivary Alpha-amylase
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary Alpha-amylaseDiagnostic test
Saliva samples will be obtained using a saliva collection system and salivary Alpha-amylase (SAA) level will be measured preoperatively, immediately postoperative, at the end of the 1st, 2nd, and 3rd postoperative days. For sampling, the swab will be placed into the patient's mouth for 2-5min by a specially trained nurse.
A minimum of 0.2mL of saliva will be needed as per the manufacturer's recommendations to saturate the swab.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative delirium (POD) group | Patients who will develop postoperative delirium Receives: Diagnostic Test: Salivary Alpha-amylase | |
| No Postoperative delirium (POD) group | Patients who will not develop postoperative delirium Receives: Diagnostic Test: Salivary Alpha-amylase |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of salivary alpha-amylase as a predictor of postoperative delirium
The accuracy of salivary alpha-amylase will be measured by saliva samples which will be obtained using a saliva collection system and SAA level will be measured preoperatively, immediately postoperative, at the end of the 1st, 2nd, and 3rd postoperative days.
Measured: 3rd day postoperatively
Secondary outcomes (4)
Incidence of postoperative delirium
Incidence of postoperative delirium will be measured.
Measured: first 5 days after surgery
Correlation of salivary alpha-amylase with C-reactive protein
Correlation of salivary alpha-amylase with C-reactive protein will be assessed.
Measured: 24 hours postoperatively
Correlation of salivary alpha-amylase with average pain score
Correlation of salivary alpha-amylase with average pain score will be assessed. Pain score will be assessed using numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable.
Measured: 24 hours postoperatively
Correlation of salivary alpha-amylase with morphine consumption
Correlation of salivary alpha-amylase with morphine consumption will be assessed.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start10 Feb 2024
- Primary completion17 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Alpha-amylaseStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ِAhmed Mohamed Ibrahim, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242275
- Sponsor's protocol ID
- 36264PR462/12/23
- Status last verified
- Oct 2024
- First submitted
- 27 Jan 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Salivary Alpha-amylase as a Predictor of Delirium After Lower Extremity Vascular Bypass Surgery
- ClinicalTrials.gov ID
- NCT06242275
- Acronym / sponsor ID
- 36264PR462/12/23
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 5 Feb 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.
The aim of this study is to evaluate the role of salivary Alpha-amylase as a predictor biomarker of POD in elderly patients undergoing limb bypass surgery.
Detailed description
Delirium is a neuropsychiatric syndrome that is characterized by the sudden onset of altered awareness, decreased ability to maintain attention, and disorders of the mental process. The pathophysiology of Postoperative delirium (POD) is related to postoperative neuroinflammation.
Biomarkers not only indicate a certain pathological state, but also provide information about disease activity and progression. Although several biomarkers are reported to predict POD, biomarkers with high sensitivity and specificity are still lacking.
Biochemical parameters associated with complement cascade (C3a, C3, C5a) and inflammatory response (IL-17A, IL-33, E-selectin, MMP9) were involved in neurocognitive regulation.
Salivary alpha amylase (SAA) enzyme is one of the most important enzyme compositions in the saliva that accounts for 40% to 50% of the total salivary proteins, and most of it is secreted from the parotid gland. SAA is locally produced by the highly differentiated epithelial acinar cells of the exocrine salivary glands, mostly of the parotid glands and plays an important role in carbohydrate hydrolysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative delirium (POD) group | – | Diagnostic Test: Salivary Alpha-amylasePatients who will develop postoperative delirium |
| No Postoperative delirium (POD) group | – | Diagnostic Test: Salivary Alpha-amylasePatients who will not develop postoperative delirium |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 60 patients aged ≥ 65 years, both sexes, American Society of Anesthesiologists (ASA) physical status III, undergoing lower extremity vascular surgery under general anesthesia.
Key inclusion criteria (4 listed)
- Age ≥ 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status III.
- Undergoing lower extremity vascular surgery under general anesthesia.
Key exclusion criteria (6 listed)
- Patients who used any medication that could affect salivary glands (such as antihypertensive, antidepressants or antipsychotic drugs).
- Inability to communicate.
- History of psychiatric diseases or previous stroke
- Previous history of pod.
- Those with smoking and drinking habits.
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 |
|---|---|---|
| Salivary Alpha-amylaseSaliva samples will be obtained using a saliva collection system and salivary Alpha-amylase (SAA) level will be measured preoperatively, immediately postoperative, at the end of the 1st, 2nd, and 3rd postoperative days. For sampling, the swab will be placed into the patient's mouth for 2-5min by a specially trained nurse. A minimum of 0.2mL of saliva will be needed as per the manufacturer's recommendations to saturate the swab. | Diagnostic test | No Postoperative delirium (POD) group, Postoperative delirium (POD) group |
Primary outcome
The accuracy of salivary alpha-amylase as a predictor of postoperative delirium
Time frame: 3rd day postoperatively
The accuracy of salivary alpha-amylase will be measured by saliva samples which will be obtained using a saliva collection system and SAA level will be measured preoperatively, immediately postoperative, at the end of the 1st, 2nd, and 3rd postoperative days.
4 secondary outcomes
Incidence of postoperative delirium
Time frame: first 5 days after surgery
Correlation of salivary alpha-amylase with C-reactive protein
Time frame: 24 hours postoperatively
Correlation of salivary alpha-amylase with average pain score
Time frame: 24 hours postoperatively
Correlation of salivary alpha-amylase with morphine consumption
Time frame: 24 hours postoperatively
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 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Salivary Alpha-amylase and Delirium, run by Tanta 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 6 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 2025. 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?
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 accuracy of salivary alpha-amylase as a predictor of postoperative delirium (time frame: 3rd day postoperatively). 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 25 Jun 2025.