Postoperative DeliriumZolDelNCT04875182
The Relationship Between Zonulin and Interleukin-8 Levels and Postoperative Delirium Development
An observational study of Postoperative Delirium, run by Dr. Gokhan Vural at 1 site in Turkey (Türkiye).
Trial summary
The relationship between zonulin and interleukin-8 levels and postoperative delirium development in patients who had femur fracture surgery under regional anesthesia Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Evaluation of Delirium development
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 2 Sep 2021
- 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: Both male and female patients over 65 years of age who will undergo femur neck and inthertrocanteric fracture surgery with regional anesthesia
Who may be able to join
- patients over 65 years with mini mental state score > 21, undergoing femur fixation surgery
Who cannot join
- anticholinergic drug use, known epilepsy, Parkinson, Alzheimer's disease, dementia, cognitive function disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Muğla Sıtkı Koçman University
Muğla, Menteşe, 48000
About this study
Official title: The Relationship Between Zonulin and Interleukin-8 Levels and Postoperative Delirium Development in Patients Who Had Femur Fracture Surgery Under Regional Anesthesia
The relationship between zonulin and interleukin-8 levels and postoperative delirium development in patients who had femur fracture surgery under regional anesthesia
Read the detailed description
Patients who are over 65 years of age and scheduled for femur fixation surgery will be included in the study. Blood samples for zonulin and interleukin-8 levels will be taken at the day prior to the surgery. All patients will be evaluated by the Turkish version of the Delirium Rating Scale-Revised-98 (DRS-R-98) for delirium development at the postoperative 1., 2. and 3. days. Patients with a DRS-R-98 score of 16 points or higher will be included in the Group Delirium. And second blood samples for zonulin and interleukin-8 levels will be taken at the time of diagnosis.
Postoperative pain scores of the patients will recorded by using a numerical rating scale (NRS).
- Conditions
- Postoperative Delirium
- Being tested
- Evaluation of Delirium development
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of Delirium developmentDiagnostic test
Also called Postoperative pain evaluation
Postoperative pain scores of the patients will recorded by using a numerical rating scale.
| Study group | Role | What they receive |
|---|---|---|
| group delirium | Patients who are over 65 years of age and scheduled for femur fixation surgery will be included in the study. Blood samples for zonulin and interleukin-8 levels will be taken at the day prior to the surgery. All patients will be evaluated by Delirium Rating Scale for delirium development at the postoperative 1., 2. and 3. days. Patients with a Delirium Rating Scale-Revised-98 score of 16 points or higher will be included in the Group Delirium. And second blood samples for zonulin and interleukin-8 levels will be taken at the time of diagnosis.
Postoperative pain scores of the patients will recorded by using a numerical rating scale. Receives: Diagnostic Test: Evaluation of Delirium development | |
| group control | Patients who are over 65 years of age and scheduled for femur fixation surgery will be included in the study. Blood samples for zonulin and interleukin-8 levels will be taken at the day prior to the surgery. All patients will be evaluated by Delirium Rating Scale for delirium development at the postoperative 1., 2. and 3. days. Patients with a Delirium Rating Scale-Revised-98 score under 16 points for postoperative 72 hours will be included in the Group Control. And second blood samples for zonulin and interleukin-8 levels will be taken at the postoperative 72. hour.
Postoperative pain scores of the patients will recorded by using a numerical rating scale. Receives: Diagnostic Test: Evaluation of Delirium development |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative Zonulin
The relation between postoperative delirium development and preoperative blood zonulin levels. The correlation between them will be analyzed by statistical analysis.
Measured: in the preoperative 24. hour
postoperative Zonulin
The relation between postoperative delirium development and postoperative blood zonulin levels The correlation between them will be analyzed by statistical analysis.
Measured: At the postoperative 72. hour
Secondary outcomes (2)
preoperative Interleukin-8
The relation between postoperative delirium development and preoperative blood interleukin-8 levels. The correlation between them will be analyzed by statistical analysis.
Measured: in the preoperative 24. hour
postoperative Interleukin-8
The relation between postoperative delirium development and postoperative blood interleukin-8 levels. The correlation between them will be analyzed by statistical analysis.
Measured: At the postoperative 72. hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 May 2021
- Primary completion2 Sep 2021
- Study completion2 Sep 2021
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Gokhan Vural
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Gokhan Vural, Muğla Sıtkı Koçman University
- Investigators
- Gökhan vural, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875182
- Sponsor's protocol ID
- 26.02.2020- 04/VI
- Acronym
- ZolDel
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD will be shared with other researchers or anyone else
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Zonulin and Interleukin-8 Levels and Postoperative Delirium Development in Patients Who Had Femur Fracture Surgery Under Regional Anesthesia
- ClinicalTrials.gov ID
- NCT04875182
- Acronym / sponsor ID
- ZolDel / 26.02.2020- 04/VI
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Dr. Gokhan VuralUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 6 May 2021 (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 relationship between zonulin and interleukin-8 levels and postoperative delirium development in patients who had femur fracture surgery under regional anesthesia
Detailed description
Patients who are over 65 years of age and scheduled for femur fixation surgery will be included in the study. Blood samples for zonulin and interleukin-8 levels will be taken at the day prior to the surgery. All patients will be evaluated by the Turkish version of the Delirium Rating Scale-Revised-98 (DRS-R-98) for delirium development at the postoperative 1., 2. and 3. days. Patients with a DRS-R-98 score of 16 points or higher will be included in the Group Delirium. And second blood samples for zonulin and interleukin-8 levels will be taken at the time of diagnosis.
Postoperative pain scores of the patients will recorded by using a numerical rating scale (NRS).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group delirium | – | Diagnostic Test: Evaluation of Delirium developmentPatients who are over 65 years of age and scheduled for femur fixation surgery will be included in the study. Blood samples for zonulin and interleukin-8 levels will be taken at the day prior to the surgery. All patients will be evaluated by Delirium Rating Scale for delirium development at the postoperative 1., 2. and 3. days. Patients with a Delirium Rating Scale-Revised-98 score of 16 points or higher will be included in the Group Delirium. And second blood samples for zonulin and interleukin-8 levels will be taken at the time of diagnosis. Postoperative pain scores of the patients will recorded by using a numerical rating scale. |
| group control | – | Diagnostic Test: Evaluation of Delirium developmentPatients who are over 65 years of age and scheduled for femur fixation surgery will be included in the study. Blood samples for zonulin and interleukin-8 levels will be taken at the day prior to the surgery. All patients will be evaluated by Delirium Rating Scale for delirium development at the postoperative 1., 2. and 3. days. Patients with a Delirium Rating Scale-Revised-98 score under 16 points for postoperative 72 hours will be included in the Group Control. And second blood samples for zonulin and interleukin-8 levels will be taken at the postoperative 72. hour. Postoperative pain scores of the patients will recorded by using a numerical rating scale. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Both male and female patients over 65 years of age who will undergo femur neck and inthertrocanteric fracture surgery with regional anesthesia
Key inclusion criteria (1 listed)
- patients over 65 years with mini mental state score > 21, undergoing femur fixation surgery
Key exclusion criteria (1 listed)
- anticholinergic drug use, known epilepsy, Parkinson, Alzheimer's disease, dementia, cognitive function disorder
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 |
|---|---|---|
| Evaluation of Delirium developmentAlso: Postoperative pain evaluationPostoperative pain scores of the patients will recorded by using a numerical rating scale. | Diagnostic test | group control, group delirium |
Primary outcome
preoperative Zonulin
Time frame: in the preoperative 24. hour
The relation between postoperative delirium development and preoperative blood zonulin levels. The correlation between them will be analyzed by statistical analysis.
postoperative Zonulin
Time frame: At the postoperative 72. hour
The relation between postoperative delirium development and postoperative blood zonulin levels The correlation between them will be analyzed by statistical analysis.
2 secondary outcomes
preoperative Interleukin-8
Time frame: in the preoperative 24. hour
postoperative Interleukin-8
Time frame: At the postoperative 72. hour
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 20 Oct 2026.
- Individual participant dataSharing planned: No. no IPD will be shared with other researchers or anyone else
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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.
Gökhan vural principal investigator
Muğla Sıtkı Koçman University
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 Dr. Gokhan Vural at 1 site in Turkey (Türkiye).
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 1 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 20 Oct 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 Turkey (Türkiye). 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?
preoperative Zonulin (time frame: in the preoperative 24. hour). The study lists 2 primary outcomes in all. 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 20 Oct 2026.