Postoperative DeliriumNCT05797194
The Association Between SIRI and POD in Older Patients
An observational study of Postoperative Delirium and Elderly, run by Changhai Hospital at 1 site in China.
Trial summary
Postoperative delirium (POD) remains one of most common complication in elderly patients receiving surgery, which is characterized by acute and fluctuating change in the level of cognition and consciousness. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium, Elderly, Surgery
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Oct 2019
- 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: Eligible patients were scheduled to undergo elective orthopedics surgery under spinal anesthesia with an expected hospital stay of at least 3 days and received postoperative patient- controlled analgesia. Delirium was evaluated at the preoperative visit, then twice daily for 3 days following surgery. Cognition assessment was conducted at preoperative visit, 24 h after surgery and 72 h after surgery. Delirium assessments were performed before 10 AM and after 5 PM in the ward. The confusion assessment method (CAM) questionnaire and cognition assessment method for MMSE were performed by the qualified doctor who trained with CAM and MMSE training manual.
Who may be able to join
- Hospital stay of at least 3 days
- More than or equal to 65 years old
- Elementary education or above
- Able to communicate
- American Society of Anesthesiologists (ASA) physical status I-III
- Mini-mental State Examination (MMSE) scores ≥ 22 points
Who cannot join
- Preoperative delirium
- Severe mental diseases
- Autoimmune-illness, chronic infectious diseases, nervous system diseases and malignancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Value of Systemic Inflammation Response Index on Postoperative Delirium in Older Patients
Postoperative delirium (POD) remains one of most common complication in elderly patients receiving surgery, which is characterized by acute and fluctuating change in the level of cognition and consciousness. Previous studies have shown that surgery and anesthesia-induced acute peripheral inflammation and neuroinflammation may lead to delirium after surgery. Systemic Inflammation Response Index (SIRI) is a more easily accessible and comprehensive inflammation marker derived from monocyte, neutrophil, and lymphocyte count, which has been investigated to assess the prognosis of cancer and infectious diseases. However, the relationship between SIRI and POD has yet to be investigated.
- Conditions
- Postoperative Delirium, Elderly, Surgery
- 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 |
|---|---|---|
| POD group | Patients were considered to surfer from postoperative delirium by a positive Confusion Assessment Method (CAM) questionnaire after surgery. | |
| No-POD group | Patients did not surfer from postoperative delirium by a positive CAM questionnaire after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confusion assessment method (CAM) score
Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.
Measured: Baseline (Before surgery)
CAM score
Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.
Measured: Postoperative day 1
CAM score
Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.
Measured: Postoperative day 2
CAM score
Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.
Measured: Postoperative day 3
Secondary outcomes (4)
The level of systemic inflammation response index (SIRI) in peripheral blood.
The SIRI was calculated as neutrophil count × monocyte count/lymphocyte count.
Measured: Baseline (Before surgery)
Mini-mental State Examination (MMSE) score
MMSE score ranges from 0 to 30 and higher score means better outcome.
Measured: Baseline (Before surgery)
MMSE score
MMSE score ranges from 0 to 30 and higher score means better outcome.
Measured: postoperative day 1
MMSE score
MMSE score ranges from 0 to 30 and higher score means better outcome.
Measured: postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Mar 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
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.
- More trials run by Changhai HospitalThe 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
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797194
- Sponsor's protocol ID
- POD-SIRI
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Value of Systemic Inflammation Response Index on Postoperative Delirium in Older Patients
- ClinicalTrials.gov ID
- NCT05797194
- Acronym / sponsor ID
- POD-SIRI
- Conditions
- Postoperative Delirium, Elderly, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 4 Apr 2023 (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.
Postoperative delirium (POD) remains one of most common complication in elderly patients receiving surgery, which is characterized by acute and fluctuating change in the level of cognition and consciousness. Previous studies have shown that surgery and anesthesia-induced acute peripheral inflammation and neuroinflammation may lead to delirium after surgery. Systemic Inflammation Response Index (SIRI) is a more easily accessible and comprehensive inflammation marker derived from monocyte, neutrophil, and lymphocyte count, which has been investigated to assess the prognosis of cancer and infectious diseases. However, the relationship between SIRI and POD has yet to be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POD group | – | –Patients were considered to surfer from postoperative delirium by a positive Confusion Assessment Method (CAM) questionnaire after surgery. |
| No-POD group | – | –Patients did not surfer from postoperative delirium by a positive CAM questionnaire after surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Eligible patients were scheduled to undergo elective orthopedics surgery under spinal anesthesia with an expected hospital stay of at least 3 days and received postoperative patient- controlled analgesia. Delirium was evaluated at the preoperative visit, then twice daily for 3 days following surgery. Cognition assessment was conducted at preoperative visit, 24 h after surgery and 72 h after surgery. Delirium assessments were performed before 10 AM and after 5 PM in the ward. The confusion assessment method (CAM) questionnaire and cognition assessment method for MMSE were performed by the qualified doctor who trained with CAM and MMSE training manual.
Key inclusion criteria (6 listed)
- Hospital stay of at least 3 days
- More than or equal to 65 years old
- Elementary education or above
- Able to communicate
- American Society of Anesthesiologists (ASA) physical status I-III
Key exclusion criteria (3 listed)
- Preoperative delirium
- Severe mental diseases
- Autoimmune-illness, chronic infectious diseases, nervous system diseases and malignancies
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
Confusion assessment method (CAM) score
Time frame: Baseline (Before surgery)
Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.
CAM score
Time frame: Postoperative day 1
Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.
CAM score
Time frame: Postoperative day 2
Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.
CAM score
Time frame: Postoperative day 3
Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.
4 secondary outcomes
The level of systemic inflammation response index (SIRI) in peripheral blood.
Time frame: Baseline (Before surgery)
Mini-mental State Examination (MMSE) score
Time frame: Baseline (Before surgery)
MMSE score
Time frame: postoperative day 1
MMSE score
Time frame: postoperative day 3
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 4 Apr 2023.
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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 Elderly, run by Changhai Hospital 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 6 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: finished, as of the sponsor's last update on 4 Apr 2023. 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?
Confusion assessment method (CAM) score (time frame: Baseline (Before surgery)). The study lists 4 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 4 Apr 2023.