Postoperative DeliriumNCT03392480
Association of Haptoglobin 2-2 With Postoperative Delirium
An observational study of Postoperative Delirium, run by Sun Yat-sen University at 8 sites in China.
Trial summary
Patients with major orthopedic surgery will be recruited. Participants will be monitored for delirium after surgery. Participants' blood will be harvested for the determination of haptoglobin types, levels of oxidative stress and inflammation. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Postoperative Delirium
- How many people
- 0 participants
- Where
- 8 sitesChina
- Study dates
- 20 Dec 2017to 30 Dec 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 45 years and older
- All sexes
- Adult, Older adult
Study population: Patients who meet the inclusive criteria will be screened as possible candidates.
Who may be able to join
- American Society of Anesthesiologists physical status I to III class for major orthopedic surgery (hip or knee replacement or spinal surgery)
- No psychological and psychiatric history and presentation before surgery
- No major organ dysfunction or failure
Who cannot join
- Anemia (hemoglobin < 100 g/l) preoperatively.
- Requires > 4 units of allogeneic red blood cell transfusion during the surgery
- Using steroids or anti-psychological and anti-psychiatric drugs. A small dose of steroid for postoperative anti-nausea/vomiting is allowed and will not be considered as a indication for exclusion.
- Can not cooperate with the study
- History of bleeding
- BMI < 18 or > 30
- History of hemoglobin metabolism disorder
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Jishuitan hospital
Beijing, 100009
Chinese PLA general hospital
Beijing, 100853
Xinqiao hospital, Army military medical university
Chongqing, 400037
Daping Hospital, Army Military Medical University
Chongqing, 400042
the First Affiliated Hospital of Southern Medical University
Guangzhou, 510515
Third affiliated hospital of southern medical university
Guangzhou, 510630
shanghai Changzheng hospital, Naval Military Medical University
Shanghai, 200433
Shenyang general hospital of military region
Shenyang, 110015
About this study
Official title: Determination of the Association of Haptoglobin 2-2 With Delirium After Orthopedic Surgery
Patients with major orthopedic surgery will be recruited. Participants will be monitored for delirium after surgery. Participants' blood will be harvested for the determination of haptoglobin types, levels of oxidative stress and inflammation. Investigators will then analyze the data to see if haptoglobin 2-2 type is associated with an increased postoperative delirium, inflammation and oxidative stress.
- Conditions
- Postoperative Delirium
- 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 |
|---|---|---|
| Adult non-haptoglobin 2-2 group | Patients are 45 to 65 years old. | |
| Adult haptoglobin 2-2 group | Patients are 45 to 65 years old. | |
| Elder non-haptoglobin 2-2 group | Patients are elder than 65 years. | |
| Elder haptoglobin 2-2 group | Patients are elder than 65 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium incidence
The incidence of delirium as assessed by intensive care unit-confusion assessment method will be determined.
Measured: From day 0 to up to 7 days after the surgery
Postoperative delirium duration
The duration of delirium as assessed by intensive care unit-confusion assessment method will be determined.
Measured: From day 0 to up to 7 days after the surgery
Secondary outcomes (2)
Oxidative stress level
The level of malondialdehyde in the blood will be measured by ELISA.
Measured: Day 0 to day 2 after the surgery
Inflammation level
The levels of interleukin 1beta and interleukin 6 in the blood will be assessed by ELISA.
Measured: Day 0 to day 2 after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start20 Dec 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Why it stopped: The research group cannot found time to do the project.
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 Sun Yat-sen 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyi Zuo, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392480
- Sponsor's protocol ID
- S2017-096-02
- Status last verified
- Jun 2023
- First submitted
- 20 Dec 2017
- Last updated
- 23 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Association of Haptoglobin 2-2 With Delirium After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT03392480
- Acronym / sponsor ID
- S2017-096-02
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The research group cannot found time to do the project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 8 Jan 2018 (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.
Patients with major orthopedic surgery will be recruited. Participants will be monitored for delirium after surgery. Participants' blood will be harvested for the determination of haptoglobin types, levels of oxidative stress and inflammation. Investigators will then analyze the data to see if haptoglobin 2-2 type is associated with an increased postoperative delirium, inflammation and oxidative stress.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult non-haptoglobin 2-2 group | – | –Patients are 45 to 65 years old. |
| Adult haptoglobin 2-2 group | – | –Patients are 45 to 65 years old. |
| Elder non-haptoglobin 2-2 group | – | –Patients are elder than 65 years. |
| Elder haptoglobin 2-2 group | – | –Patients are elder than 65 years. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the inclusive criteria will be screened as possible candidates.
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status I to III class for major orthopedic surgery (hip or knee replacement or spinal surgery)
- No psychological and psychiatric history and presentation before surgery
- No major organ dysfunction or failure
Key exclusion criteria (7 listed)
- Anemia (hemoglobin < 100 g/l) preoperatively.
- Requires > 4 units of allogeneic red blood cell transfusion during the surgery
- Using steroids or anti-psychological and anti-psychiatric drugs. A small dose of steroid for postoperative anti-nausea/vomiting is allowed and will not be considered as a indication for exclusion.
- Can not cooperate with the study
- History of bleeding
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
Postoperative delirium incidence
Time frame: From day 0 to up to 7 days after the surgery
The incidence of delirium as assessed by intensive care unit-confusion assessment method will be determined.
Postoperative delirium duration
Time frame: From day 0 to up to 7 days after the surgery
The duration of delirium as assessed by intensive care unit-confusion assessment method will be determined.
2 secondary outcomes
Oxidative stress level
Time frame: Day 0 to day 2 after the surgery
Inflammation level
Time frame: Day 0 to day 2 after the surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No. No plan to share individual participant data with other researchers
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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.
8 sites 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 Sun Yat-sen University at 8 sites 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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Postoperative delirium incidence (time frame: From day 0 to up to 7 days after the surgery). 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 23 Jun 2023.