WHiTE16-DELPHIC: An investigation of people 60 years and over with a broken hip to determine whether they are less likely to have delirium after hip surgery if we treat them with corticosteroids during the operation
| ISRCTN | ISRCTN22402653 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22402653 |
| Clinical Trials Information System (CTIS) | 2020-003719-83 |
| Central Portfolio Management System (CPMS) | 59647 |
| National Institute for Health and Care Research (NIHR) | 206655 |
| Sponsor | University of Oxford |
| Funder | National Institute for Health and Care Research |
- Submission date
- 08/12/2025
- Registration date
- 24/12/2025
- Last edited
- 24/12/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This study has been designed following a James Lind Alliance Patient and Public Research Priority Setting Partnership, which identified the following question as a key research priority: “What are the best treatments to prevent and treat confusion and delirium after surgery in adults with a broken bone in the leg?” The study has been co-produced with the UK Musculoskeletal Trauma Patient and Public Involvement Group. A broken hip (hip fracture) is a very serious injury that requires surgery to repair or replace the broken bone followed by a long period in hospital to recover. Around a quarter of patients with hip fractures die within a year and those that survive have a permanent loss of quality of life. Worldwide there are 1.3 million hip fractures each year, with more than 70,000 in the UK. Around a quarter of patients who have a hip fracture have an episode of ‘delirium’ around the time of their surgery. Delirium is a condition where the patient loses awareness of themselves and their environment, and has difficulty thinking clearly. For relatives and friends, and the patient, delirium is very disturbing. The symptoms of delirium are similar to those of patients with dementia but develop over a short period and tend to vary over time. In the short-term, delirium leads to longer stays in hospital and an increased risk of complications including death. In the longer term, delirium is closely linked with an increased risk of developing dementia. Delirium is thought to be caused by inflammation in the brain. The inflammation is triggered by the injury and is thought to get worse during surgery. This study will investigate a drug called dexamethasone which is given during surgery. Dexamethasone is a commonly used anti-inflammatory drug. This study aims to decide if patients who have operations on broken hips are less likely to have delirium if we treat them with dexamethason during the operation.
Who can participate?
Patients aged over 60 years with a hip fracture, apart from the very small number of patients who do not have an operation on their hip.
What does the study involve?
Patients at approximately 8 hospitals in the UK will be approached to take part in the study. 94 participants will take part, with half being allocated by chance to receiving dexamethasone, and half to receiving standard care (no drug). Neither the patients nor their doctors will know which treatment they had to make the study fair. All other elements of the patient’s treatment will follow the normal care pathway for all hip fracture patients at the hospital. Baseline information including pre-injury mobility and residential status will be collected. Participants or their proxies will also be asked to complete the EQ-5D-5L questionnaire to indicate their typical pre-injury quality of life status. A simple questionnaire called the Memorial Delirium Assessment Scale (MDAS) will be used to measure symptoms of delirium in the first five days after surgery. Participants’ mobility, quality of life and complications, including the risk of infection and developing dementia in the 12 months after surgery will also be measured.
What are the possible benefits and risks of participating?
Dexamethasone is already used very widely in the NHS as a treatment for anti-sickness, but it has not been tested to see if it could help prevent delirium after surgery. Rarely a mild increase in blood sugar levels may occur, which returns to normal within 24 hours, this can be more common in people with diabetes but there is no evidence this causes any significant problems. Other reactions have only been associated with a long treatment with dexamethasone, so are not expected in this study where only a one-off dose is given.
Hip fracture surgery carries some risk, including infection in the surgical wound, blood clots, chest or urine infection. These risks are the same for people who are not part of this research project.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
January 2026 to February 2027
Who is funding the study?
National Institute for Health and Care Research, Research for Patient Benefit (RfPB) programme
Who is the main contact?
Central trial team, white16-delphic@ndorms.ox.ac.uk
Contact information
Scientific, Public, Principal investigator
Oxford Trauma and Emergency Care, Kadoori Centre, University of Oxford
Oxford
OX3 9DU
United Kingdom
| white16-delphic@ndorms.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | World Hip Trauma Evaluation - DELPHIC: Delirium Prevention in Hip Fracture with Corticosteroids |
| Study acronym | WHiTE-DELPHIC |
| Study objectives | 1. To confirm willingness of patients and healthcare professionals to participate in this randomised comparison 2. To confirm whether there is an indication of a meaningful effect in the primary outcome (peak MDAS score) of the proposed definitive randomised comparison 3. To confirm process practicality in terms of intervention delivery and data collection for a definitive randomised comparison |
| Ethics approval(s) |
Approved 14/10/2025, South Central - Berkshire Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8178; berkshire.rec@hra.nhs.uk), ref: 20/SC/0452 |
| Health condition(s) or problem(s) studied | Hip fracture |
| Intervention | WHiTE 14-PRESSURE 3 is a randomised comparison appended to the World Hip Trauma Evaluation (WHiTE ) Platform. WHiTE is a platform trial designed to efficiently deliver multiple randomised comparisons of interventions for patients aged 60 years and over with a hip fracture. The platform and its appended randomised comparisons are governed by one single set of ethical and regulatory approvals and an explicit legal basis and processing purpose for the use of patient-level data. The Platform affords a common core dataset and documentation. Individual randomised comparisons are not dependent on each other and each will have unique start and stop dates and publication of results without compromising the integrity of the platform. Specifically for WHiTE 16-DELPHIC: randomisation will be on a 1:1 basis to standard of care plus dexamethasone or standard of care, stratified by recruitment centre and the presence/absence of cognitive impairment at presentation (proxy consent will be used as a surrogate indicator for lack of cognitive impairment). The intervention will be a single intravenous bolus of 13.2 mg dexamethasone base (equivalent to 16 mg dexamethasone phosphate) at the start of anaesthesia. The standard care will be as per routine practice at each recruitment centre |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 05/04/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 60 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 94 |
| Key inclusion criteria | As per the overarching Platform Master Protocol; all adults aged 60 years or over diagnosed with a hip fracture that in the opinion of the treating surgeon may benefit from surgical treatment. |
| Key exclusion criteria | Platform exclusion criteria: 1. Previous participation in the same randomised comparison 2. A second hip fracture (on the other side), while the patient is still enrolled in the Platform following their first hip fracture Additional exclusion criteria for DELPHIC: 1. Acute uncontrolled infection as diagnosed by the treating clinician. 2. Hypersensitivity to dexamethasone or excipients within the preparation 3. Use of oral or / intravenous corticosteroids at or following admission. 4. Concurrent participation in a conflicting clinical trial of an investigational medicinal product 5. Receipt of a live vaccine within 2 weeks prior to treatment 6. Known gastrointestinal ulcer 7. Congestive cardiac failure 8. History of steroid psychosis 9. Current glaucoma or corneal ulcer 10. Severe ulcerative colitis 11. Active diverticulitis 12. Suspected or confirmed strongyloidiasis 13. Known history of tuberculosis |
| Date of first enrolment | 05/01/2026 |
| Date of final enrolment | 05/02/2027 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
College Street
Nuneaton
CV10 7DJ
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the Lead Investigator (Prof. Matt Costa, matthew.costa@ndorms.ox.ac.uk). Each request will be reviewed and decided upon on a case-by-case basis. Participants will be informed via the Participant Information Sheet (and will consent to the contents of this PIS) of the possibility of de-identified datasets being made available following appropriate requests. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 11/09/2025 | 19/12/2025 | No | No |
Additional files
Editorial Notes
08/12/2025: Study's existence confirmed by the NIHR.
