Hip FracturesNCT05857462
The Impact of Integrated Preoperative Fascia Iliaca Compartment Block in Elderly Hip Fracture
A study testing Post-admission FICB in people with Hip Fractures and Pain, Acute, run by Mahidol University at 1 site in Thailand.
Trial summary
This prospective randomized controlled study is aimed to determine the advantages of post-admission fascia iliaca compartment block (FICB) in geriatric hip fracture surgery combination with multimodal analgesia compared with no post-admission FICB. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Hip Fractures, Pain, Acute, Hip Fracture Surgery
- What is being tested?
- Post-admission FICB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteThailand
- Study dates
- May 2023to Mar 2026
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who are aged ≥65 , <85 years old and diagnose hip fracture in 8 hospitals
- Planed for fast-track hip surgery
- Isolated acute hip fracture
- Pain on admission during movement ≥ 4 (moderate pain)
Who cannot join
- refusal to participate the study
- ASA physical status >III
- 2. duration of fracture more than 7 days before admission 3. hip fracture after/at previous instrumentation 4. hip fracture causing by a traffic accident or high energy force 5. suspected pathologic fracture 6. unable to communication 7. abnormal consciousness or severe cognitive dysfunction that could not communication such as mental retardation, severe Alzheimer's disease and schizophenia 8. allergy to local anesthetic drug
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Suwimon Tangwiwat, M.D, (66)81-645-6167, stangwiwat@yahoo.com
Nichapat Thongkaew, 6624197978 ext. 501, nokaeko@gmail.com
About this study
Official title: A Randomized Controlled Trial to Evaluate the Impact of Integrated Preoperative Fascia Iliaca Compartment Block (FICB) for Fast-track Surgery in Elderly Hip Fracture
This prospective randomized controlled study is aimed to determine the advantages of post-admission fascia iliaca compartment block (FICB) in geriatric hip fracture surgery combination with multimodal analgesia compared with no post-admission FICB. The primary outcome is incidence of delirium during hospital admission. Secondary outcomes are incidence of delirium at hospital discharge, pre- and post-operative pain intensity, peri-operative complications, opioid-related side effects, post-operative complications and length of hospital stay, and morbidities and mortality (in-hospital and 30 days).
Read the detailed description
Population: elderly patients age ≥ 65 years old, diagnosed with an isolated acute hip fracture within 7 days and plan to receive fast-track hip fracture. Statistic analysis plan surgery within 48 hours after hospital admission.
Study population: elderly isolated hip fracture patients who are admitted in those 8 hospitals centers in Thailand and have moderate pain or higher than moderate pain during movement since hospital admission.
Sample size : 210 patients per group (drop out 10%) total 420 patients
Statistical analysis: SPSS will be used for study analysis. The category variables will be present as number and percentage, and chi-square or fisher exact test will be used to compare between the groups.The continuous variables will be tested the distribution, data presentation will be mean and standard deviation (SD) for normal distribution while median and interquartile rang (IQR) for non-normal distribution. Student t test or Wilcoxson rank some test will be used as appropriate to test for different between the group. And p value less than 0.05 will be considered statically significance.
- Being tested
- Post-admission FICB
- Medical subject headings
- Hip Fractures, Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-admission FICBProcedure or surgery
Post-admission supra-inguinal FICB in hip fracture patient with 0.33% bupivacaine 30 ml
| Study group | Role | What they receive |
|---|---|---|
| Post-admission FICB | Experimental | Post-admission FICB, drug 0.33% bupivacaine 30 ml + Pre-operative FICB 0.33% bupivacaine 30 ml. Peri-operative pain management protocol : paracetamol + opioid. Receives: Procedure: Post-admission FICB |
| Only preoperative FICB | No intervention | No post-admission FICB + Pre-operative FICB 0.33% bupivacaine 30 ml. Peri-operative pain management protocol : paracetamol + opioid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital Delirium
Incidence of delirium using Nursing Delirium Screening Scale (NU-DESC) Thai version plus backward counting 30-1. Total Scale 11 ( > or = 2 means delirium). The patient will be assessed once a day in the morning period.
Measured: In hospital admission, assess up to 30 days
Secondary outcomes (11)
Preoperative pain score
Numeric rating scale (0-10; 0=no pain, 10 worst pain imaginable) will be used. The patient will be assessed every 6 hours duration until receiving surgery within 48 hours.
Measured: 48 hours after hospital admission
Post-operative pain score
Numeric rating scale (0-10; 0=no pain, 10 worst pain imaginable) will be used. The patient will be assessed every 6 hours duration postoperatively until 72 hours
Measured: Until postoperative 72 hours
Preoperative morphine consumption
Milligram morphine equivalent
Measured: 48 hours after hospital admission
Postoperative morphine consumption
Milligram morphine equivalent
Measured: Until postoperative 72 hours
Major adverse cardiac events
Incidence of major adverse cardiac events (fatal arrythmia, cardiac arrest, myocardial infarction, stroke, pulmonary emboli)
Measured: In hospital admission, up to 30 days
In-hospital morbidities
Incidence of in-hospital morbidities include deep vein thrombosis sepsis, pneumonia, respiratory failure, urinary tract infection, acute kidney injury
Measured: In hospital admission, up to 30 days
Discharge hospital status
Self-care ability to perform the activity of daily living (ADLs)
Measured: On hospital discharge day, up to 30 days
Length of hospital stay
Days of hospital stay
Measured: In hospital admission, up to 30 days
In-hospital mortality rate
Incidence related to all causes of death implant related (implant removal, implant exchange, implant failure,) infection related, bleeding related, non-union fracture, re-fracture
Measured: In hospital admission, up to 30 days
30 days mortality
Incidence of death
Measured: In hospital admission, up to 30 days
Predict 30-day mortality in hip fracture patient with multiple comorbidities
Charlson Comorbidity Index (CCI) with 19 item-version (adjusted weights for each condition). Higher score of Charlson Comorbidity Index (CCI) is related to higher mortality. CCI score 1-2 = mild, 3-5 scores = moderate, > or = 5 scores = severe.
Measured: On admission day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study startMay 2023 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Responsible party
- Sponsor
- Investigators
- Suwimon Tangwiwat, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857462
- Sponsor's protocol ID
- CREC015/2023
- Status last verified
- May 2023
- First submitted
- 29 Mar 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chotanaphuti T, Jareonarpornwatana A, Laoruengthana A. The mortality rate after thromboembolism prophylaxis in the hip fracture surgery. J Med Assoc Thai. 2009 Dec;92 Suppl 6:S115-9.
PubMed 20120672Chaysri R, Leerapun T, Klunklin K, Chiewchantanakit S, Luevitoonvechkij S, Rojanasthien S. Factors related to mortality after osteoporotic hip fracture treatment at Chiang Mai University Hospital, Thailand, during 2006 and 2007. J Med Assoc Thai. 2015 Jan;98(1):59-64.
PubMed 25775733Kulachote N, Sa-Ngasoongsong P, Sirisreetreerux N, Wongsak S, Suphachatwong C, Wajanavisit W, Kawinwonggowit V. The Impacts of Early Hip Surgery in High-Risk Elderly Taking Antithrombotic Agents and Afflicted with Intertrochanteric Fracture. J Med Assoc Thai. 2015 Sep;98 Suppl 8:S76-81.
PubMed 26529819Haugan K, Johnsen LG, Basso T, Foss OA. Mortality and readmission following hip fracture surgery: a retrospective study comparing conventional and fast-track care. BMJ Open. 2017 Aug 29;7(8):e015574. doi: 10.1136/bmjopen-2016-015574.
PubMed 28851773Pollmann CT, Rotterud JH, Gjertsen JE, Dahl FA, Lenvik O, Aroen A. Fast track hip fracture care and mortality - an observational study of 2230 patients. BMC Musculoskelet Disord. 2019 May 24;20(1):248. doi: 10.1186/s12891-019-2637-6.
PubMed 31122228Munoz Vives JM, Jornet-Gibert M, Camara-Cabrera J, Esteban PL, Brunet L, Delgado-Flores L, Camacho-Carrasco P, Torner P, Marcano-Fernandez F; Spanish HIP-COVID Investigation Group. Mortality Rates of Patients with Proximal Femoral Fracture in a Worldwide Pandemic: Preliminary Results of the Spanish HIP-COVID Observational Study. J Bone Joint Surg Am. 2020 Jul 1;102(13):e69. doi: 10.2106/JBJS.20.00686.
PubMed 32618917Lewis PM, Waddell JP. When is the ideal time to operate on a patient with a fracture of the hip? : a review of the available literature. Bone Joint J. 2016 Dec;98-B(12):1573-1581. doi: 10.1302/0301-620X.98B12.BJJ-2016-0362.R2.
PubMed 27909117Pincus D, Ravi B, Wasserstein D, Huang A, Paterson JM, Nathens AB, Kreder HJ, Jenkinson RJ, Wodchis WP. Association Between Wait Time and 30-Day Mortality in Adults Undergoing Hip Fracture Surgery. JAMA. 2017 Nov 28;318(20):1994-2003. doi: 10.1001/jama.2017.17606.
PubMed 29183076Jiang M, Liu S, Deng H, Liang X, Bo Z. The efficacy and safety of fast track surgery (FTS) in patients after hip fracture surgery: a meta-analysis. J Orthop Surg Res. 2021 Feb 27;16(1):162. doi: 10.1186/s13018-021-02277-w.
PubMed 33639957Steenberg J, Moller AM. Systematic review of the effects of fascia iliaca compartment block on hip fracture patients before operation. Br J Anaesth. 2018 Jun;120(6):1368-1380. doi: 10.1016/j.bja.2017.12.042. Epub 2018 Apr 5.
PubMed 29793602Fadhlillah F, Chan D, Pelosi P, Rubulotta F. Systematic review and meta-analysis of single injection fascia iliaca blocks in the peri-operative management of patients with hip fractures. Minerva Anestesiol. 2019 Nov;85(11):1211-1218. doi: 10.23736/S0375-9393.19.13535-3. Epub 2019 Jul 4.
PubMed 31274264Wan HY, Li SY, Ji W, Yu B, Jiang N. Fascia Iliaca Compartment Block for Perioperative Pain Management of Geriatric Patients with Hip Fractures: A Systematic Review of Randomized Controlled Trials. Pain Res Manag. 2020 Nov 25;2020:8503963. doi: 10.1155/2020/8503963. eCollection 2020.
PubMed 33294087Hao J, Dong B, Zhang J, Luo Z. Pre-emptive analgesia with continuous fascia iliaca compartment block reduces postoperative delirium in elderly patients with hip fracture. A randomized controlled trial. Saudi Med J. 2019 Sep;40(9):901-906. doi: 10.15537/smj.2019.9.24483.
PubMed 31522217Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8. doi: 10.1097/01.anes.0000264764.56544.d2.
PubMed 17413915Groot L, Dijksman LM, Simons MP, Zwartsenburg MM, Rebel JR. Single Fascia Iliaca Compartment Block is Safe and Effective for Emergency Pain Relief in Hip-fracture Patients. West J Emerg Med. 2015 Dec;16(7):1188-93. doi: 10.5811/westjem.2015.10.28270. Epub 2015 Dec 14.
PubMed 26759680
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Impact of Integrated Preoperative Fascia Iliaca Compartment Block (FICB) for Fast-track Surgery in Elderly Hip Fracture
- ClinicalTrials.gov ID
- NCT05857462
- Acronym / sponsor ID
- CREC015/2023
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Study start
- May 2023 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 12 May 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.
This prospective randomized controlled study is aimed to determine the advantages of post-admission fascia iliaca compartment block (FICB) in geriatric hip fracture surgery combination with multimodal analgesia compared with no post-admission FICB. The primary outcome is incidence of delirium during hospital admission. Secondary outcomes are incidence of delirium at hospital discharge, pre- and post-operative pain intensity, peri-operative complications, opioid-related side effects, post-operative complications and length of hospital stay, and morbidities and mortality (in-hospital and 30 days).
Detailed description
Population: elderly patients age ≥ 65 years old, diagnosed with an isolated acute hip fracture within 7 days and plan to receive fast-track hip fracture. Statistic analysis plan surgery within 48 hours after hospital admission.
Study population: elderly isolated hip fracture patients who are admitted in those 8 hospitals centers in Thailand and have moderate pain or higher than moderate pain during movement since hospital admission.
Sample size : 210 patients per group (drop out 10%) total 420 patients
Statistical analysis: SPSS will be used for study analysis. The category variables will be present as number and percentage, and chi-square or fisher exact test will be used to compare between the groups.The continuous variables will be tested the distribution, data presentation will be mean and standard deviation (SD) for normal distribution while median and interquartile rang (IQR) for non-normal distribution. Student t test or Wilcoxson rank some test will be used as appropriate to test for different between the group. And p value less than 0.05 will be considered statically significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-admission FICB | Experimental | Procedure: Post-admission FICBPost-admission FICB, drug 0.33% bupivacaine 30 ml + Pre-operative FICB 0.33% bupivacaine 30 ml. Peri-operative pain management protocol : paracetamol + opioid. |
| Only preoperative FICB | No intervention | –No post-admission FICB + Pre-operative FICB 0.33% bupivacaine 30 ml. Peri-operative pain management protocol : paracetamol + opioid. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients who are aged ≥65 , <85 years old and diagnose hip fracture in 8 hospitals
- Planed for fast-track hip surgery
- Isolated acute hip fracture
- Pain on admission during movement ≥ 4 (moderate pain)
Key exclusion criteria (3 listed)
- refusal to participate the study
- ASA physical status >III
- 2. duration of fracture more than 7 days before admission 3. hip fracture after/at previous instrumentation 4. hip fracture causing by a traffic accident or high energy force 5. suspected pathologic fracture 6. unable to communication 7. abnormal consciousness or severe cognitive dysfunction that could not communication such as mental retardation, severe Alzheimer's disease and schizophenia 8. allergy to local anesthetic drug
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 |
|---|---|---|
| Post-admission FICBPost-admission supra-inguinal FICB in hip fracture patient with 0.33% bupivacaine 30 ml | Procedure or surgery | Post-admission FICB |
Primary outcome
In-hospital Delirium
Time frame: In hospital admission, assess up to 30 days
Incidence of delirium using Nursing Delirium Screening Scale (NU-DESC) Thai version plus backward counting 30-1. Total Scale 11 ( > or = 2 means delirium). The patient will be assessed once a day in the morning period.
11 secondary outcomes
Preoperative pain score
Time frame: 48 hours after hospital admission
Post-operative pain score
Time frame: Until postoperative 72 hours
Preoperative morphine consumption
Time frame: 48 hours after hospital admission
Postoperative morphine consumption
Time frame: Until postoperative 72 hours
Major adverse cardiac events
Time frame: In hospital admission, up to 30 days
In-hospital morbidities
Time frame: In hospital admission, up to 30 days
Discharge hospital status
Time frame: On hospital discharge day, up to 30 days
Length of hospital stay
Time frame: In hospital admission, up to 30 days
In-hospital mortality rate
Time frame: In hospital admission, up to 30 days
30 days mortality
Time frame: In hospital admission, up to 30 days
Predict 30-day mortality in hip fracture patient with multiple comorbidities
Time frame: On admission day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Background: PubMed 20120672Chotanaphuti T, Jareonarpornwatana A, Laoruengthana A. The mortality rate after thromboembolism prophylaxis in the hip fracture surgery. J Med Assoc Thai. 2009 Dec;92 Suppl 6:S115-9.
- Background: PubMed 25775733Chaysri R, Leerapun T, Klunklin K, Chiewchantanakit S, Luevitoonvechkij S, Rojanasthien S. Factors related to mortality after osteoporotic hip fracture treatment at Chiang Mai University Hospital, Thailand, during 2006 and 2007. J Med Assoc Thai. 2015 Jan;98(1):59-64.
- Background: PubMed 26529819Kulachote N, Sa-Ngasoongsong P, Sirisreetreerux N, Wongsak S, Suphachatwong C, Wajanavisit W, Kawinwonggowit V. The Impacts of Early Hip Surgery in High-Risk Elderly Taking Antithrombotic Agents and Afflicted with Intertrochanteric Fracture. J Med Assoc Thai. 2015 Sep;98 Suppl 8:S76-81.
- Background: PubMed 28851773Haugan K, Johnsen LG, Basso T, Foss OA. Mortality and readmission following hip fracture surgery: a retrospective study comparing conventional and fast-track care. BMJ Open. 2017 Aug 29;7(8):e015574. doi: 10.1136/bmjopen-2016-015574.
- Background: PubMed 31122228Pollmann CT, Rotterud JH, Gjertsen JE, Dahl FA, Lenvik O, Aroen A. Fast track hip fracture care and mortality - an observational study of 2230 patients. BMC Musculoskelet Disord. 2019 May 24;20(1):248. doi: 10.1186/s12891-019-2637-6.
- Background: PubMed 32618917Munoz Vives JM, Jornet-Gibert M, Camara-Cabrera J, Esteban PL, Brunet L, Delgado-Flores L, Camacho-Carrasco P, Torner P, Marcano-Fernandez F; Spanish HIP-COVID Investigation Group. Mortality Rates of Patients with Proximal Femoral Fracture in a Worldwide Pandemic: Preliminary Results of the Spanish HIP-COVID Observational Study. J Bone Joint Surg Am. 2020 Jul 1;102(13):e69. doi: 10.2106/JBJS.20.00686.
- Background: PubMed 27909117Lewis PM, Waddell JP. When is the ideal time to operate on a patient with a fracture of the hip? : a review of the available literature. Bone Joint J. 2016 Dec;98-B(12):1573-1581. doi: 10.1302/0301-620X.98B12.BJJ-2016-0362.R2.
- Background: PubMed 29183076Pincus D, Ravi B, Wasserstein D, Huang A, Paterson JM, Nathens AB, Kreder HJ, Jenkinson RJ, Wodchis WP. Association Between Wait Time and 30-Day Mortality in Adults Undergoing Hip Fracture Surgery. JAMA. 2017 Nov 28;318(20):1994-2003. doi: 10.1001/jama.2017.17606.
- Background: PubMed 33639957Jiang M, Liu S, Deng H, Liang X, Bo Z. The efficacy and safety of fast track surgery (FTS) in patients after hip fracture surgery: a meta-analysis. J Orthop Surg Res. 2021 Feb 27;16(1):162. doi: 10.1186/s13018-021-02277-w.
- Background: PubMed 29793602Steenberg J, Moller AM. Systematic review of the effects of fascia iliaca compartment block on hip fracture patients before operation. Br J Anaesth. 2018 Jun;120(6):1368-1380. doi: 10.1016/j.bja.2017.12.042. Epub 2018 Apr 5.
- Background: PubMed 31274264Fadhlillah F, Chan D, Pelosi P, Rubulotta F. Systematic review and meta-analysis of single injection fascia iliaca blocks in the peri-operative management of patients with hip fractures. Minerva Anestesiol. 2019 Nov;85(11):1211-1218. doi: 10.23736/S0375-9393.19.13535-3. Epub 2019 Jul 4.
- Background: PubMed 33294087Wan HY, Li SY, Ji W, Yu B, Jiang N. Fascia Iliaca Compartment Block for Perioperative Pain Management of Geriatric Patients with Hip Fractures: A Systematic Review of Randomized Controlled Trials. Pain Res Manag. 2020 Nov 25;2020:8503963. doi: 10.1155/2020/8503963. eCollection 2020.
- National Institute for Health and Care Excellence. Clinical guideline: Hip fracture: management 2011.Link provided by the sponsor.
- 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.
Suwimon Tangwiwat, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-admission FICB in people with Hip Fractures and Pain, Acute, run by Mahidol University at 1 site in Thailand.
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 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: status not confirmed, as of the sponsor's last update on 12 May 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suwimon Tangwiwat, MD (66816456167, stangwiwat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital Delirium (time frame: In hospital admission, assess up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05857462, which also lists 23 linked publications.
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 12 May 2023.