Postoperative DeliriumPODNCT05179252
Shenfu Injection for Postoperative Delirium (SFI for POD)
A study testing Shen-Fu injection and normal saline in people with Postoperative Delirium, run by Shandong University of Traditional Chinese Medicine.
Trial summary
Surgery or trauma may cause serious problem to patients, especially for senile ones, like postoperative delirium or more postoperative complications. Here, we conduct a investigation of SFI for preventing the happening of POD or postoperative complications. Read more about this study
- Who is it for?
- Ages 75 to 90 years
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Shen-Fu injection and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 1 Dec 2022
- Phase
- Interventional
- 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 75 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- hip fracture surgery under epidural anesthesia
Who cannot join
- Severe dementia, hearing/vision impairment, coma, etc., unable to communicate;
- patients with end-stage diseases such as tumor;
- 3 months after myocardial infarction, cerebral infarction;
- severe heart, liver and renal dysfunction.
Trial locations and contacts
No sites are listed yet.
zhang xin contact
About this study
Official title: POD and Postoperative Outcomes in Senile Patients After SFI for Hip Fracture Surgery: A Randomized Trial
Surgery or trauma may cause serious problem to patients, especially for senile ones, like postoperative delirium or more postoperative complications. Here, we conduct a investigation of SFI for preventing the happening of POD or postoperative complications.
Read the detailed description
SFI(Shenfu Injection), a historical medical herbal medicine of traditional Chinese, which may produced much benefit to clinical patients with furtigue after major surgery, because it was a comment sense to think of energy loss if they experience surgical damage. Here, we administrated intravenously SFI into senile patients, who receiving hip fracture surgery, to avoid bad results or serious postoperative outcomes, in case of enhancing recovery after surgery.
- Conditions
- Postoperative Delirium
- Being tested
- Shen-Fu injection, normal saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shen-Fu injectionDrug
Also called sanjiu yaan
Chinese patent medicine made by modern technology
normal salineDrug
Also called physiological saline solution
0.9% normal saline, used for sham control
| Study group | Role | What they receive |
|---|---|---|
| SFI intervention group | Experimental | shenfu injection used during surgery, day one and two after surgery, 50ml,iv drop. Receives: Drug: Shen-Fu injection |
| Control group | Sham comparator | same volume of normal saline used during surgery, day one and two after surgery, 50ml,iv drop. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative delirium within 7 days
postoperative delirium(POD), assessed with Confusion Assessment Method scale and Richmond Agitation-Sedation Scale together.
Measured: day 1-7 after surgery, more scores means higher incidence of POD
Secondary outcomes (6)
non-delirium complications
postoperative complications except for delirium
Measured: day 1-7 after surgery
length of stay
length of hospital stay
Measured: approximately day 1 in hospital to day 7
pain assessment within 3 days
postoperative pain estimated with Numerical Rating Scale
Measured: day 1-3 after surgery, higher scores mean more pain.
all-caused mortality within 30 days
short-term follow up
Measured: 30 days after surgery
survival in 1 year
long-term follow up
Measured: 1 year discharge from hospital
adverse events to shenfu injection
adverse events caused form shenfu injection
Measured: approximately day1-7 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Dec 2022 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Institute of Science and Technology Information
- Responsible party
- Principal investigator, weiliang zhang, Shandong University of Traditional Chinese Medicine
- Investigators
- zhang xin, Study director, Shandong University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179252
- Sponsor's protocol ID
- SZYA20210603-A1
- Acronym
- POD
- Status last verified
- Dec 2021
- First submitted
- 16 Nov 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POD and Postoperative Outcomes in Senile Patients After SFI for Hip Fracture Surgery: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05179252
- Acronym / sponsor ID
- POD / SZYA20210603-A1
- Conditions
- Postoperative Delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Shandong University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shandong Institute of Science and Technology Information
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 5 Jan 2022 (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.
Surgery or trauma may cause serious problem to patients, especially for senile ones, like postoperative delirium or more postoperative complications. Here, we conduct a investigation of SFI for preventing the happening of POD or postoperative complications.
Detailed description
SFI(Shenfu Injection), a historical medical herbal medicine of traditional Chinese, which may produced much benefit to clinical patients with furtigue after major surgery, because it was a comment sense to think of energy loss if they experience surgical damage. Here, we administrated intravenously SFI into senile patients, who receiving hip fracture surgery, to avoid bad results or serious postoperative outcomes, in case of enhancing recovery after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SFI intervention group | Experimental | Drug: Shen-Fu injectionshenfu injection used during surgery, day one and two after surgery, 50ml,iv drop. |
| Control group | Sham comparator | Drug: normal salinesame volume of normal saline used during surgery, day one and two after surgery, 50ml,iv drop. |
Who may qualify
- Ages
- 75 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- hip fracture surgery under epidural anesthesia
Key exclusion criteria (4 listed)
- Severe dementia, hearing/vision impairment, coma, etc., unable to communicate;
- patients with end-stage diseases such as tumor;
- 3 months after myocardial infarction, cerebral infarction;
- severe heart, liver and renal dysfunction.
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 |
|---|---|---|
| Shen-Fu injectionAlso: sanjiu yaanChinese patent medicine made by modern technology | Drug | SFI intervention group |
| normal salineAlso: physiological saline solution0.9% normal saline, used for sham control | Drug | Control group |
Primary outcome
incidence of postoperative delirium within 7 days
Time frame: day 1-7 after surgery, more scores means higher incidence of POD
postoperative delirium(POD), assessed with Confusion Assessment Method scale and Richmond Agitation-Sedation Scale together.
6 secondary outcomes
non-delirium complications
Time frame: day 1-7 after surgery
length of stay
Time frame: approximately day 1 in hospital to day 7
pain assessment within 3 days
Time frame: day 1-3 after surgery, higher scores mean more pain.
all-caused mortality within 30 days
Time frame: 30 days after surgery
survival in 1 year
Time frame: 1 year discharge from hospital
adverse events to shenfu injection
Time frame: approximately day1-7 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- 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. This study is not recruiting at the moment.
zhang xin contact
zhang xin study director
Shandong University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Shen-Fu injection and normal saline in people with Postoperative Delirium, run by Shandong University of Traditional Chinese Medicine.
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 4 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: status not confirmed, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhang weiliang (13365316885, hezhangweiliang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative delirium within 7 days (time frame: day 1-7 after surgery, more scores means higher incidence of POD). 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 5 Jan 2022.