Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
62
Countries
1
Sites
2
POST -OPERATIVE LOWER LIMB EDEMA
Evaluate the anti-inflammatory role of dexamethasone in reducing postoperative edema in patients undergoing total hip arthroplasty
Key facts
- Sponsor
- Hospital Universitari De Girona Doctor Josep Trueta
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Decision date (initial)
- 2024-10-21
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518133-28-00
- EudraCT number
- 2020-005034-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Evaluate the anti-inflammatory role of dexamethasone in reducing postoperative edema in patients undergoing total hip arthroplasty
Secondary objectives 3
- Evaluate the reduction of postoperative pain in patients who have been administered dexamethasone preoperatively
- Study the influence of the different approaches to Total Hip Arthroplasty on the appearance of postoperative edema in the operated limb.
- Describe the influence of intravenous peroperative Dexamethasone in improving rapid recovery programs in total hip arthroplasty
Conditions and MedDRA coding
POST -OPERATIVE LOWER LIMB EDEMA
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10014220 | Edema extremities | 10018065 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | INTERVENTION Aquellos pacientes seleccionados que cumplan con los criterios de inclusión y ninguno de exclusión y firmen el consentimiento informado para participar en el estudio serán aleatorizados a una de las ramas del tratamiento. La aleatorización se realizará mediante el programa PASS 2020 para generar la lista.La prescripción se realizará por parte de anestesia, que hará llegar la receta a farmacia, donde se aleatorizará al paciente El servicio de farmacia preparará una jeringa con un volumen de 5 ml de dexametasona (20 mg/5ml) o placebo (suero fisiológico (SF)) que se dispensará en función de la rama del estudio asignada al paciente.
|
Randomised Controlled | Double | [{"id":86882,"code":2,"name":"Investigator"}] | INTERVENTION ARM: Se les administrará una única dosis de 0,2 mg/Kg (equivalente a 0,05ml/kg de la preparación de farmacia) de dexametasona, que serán diluidos por parte de enfermería y en el quirófano, en 500 ml de suero fisiológico CONTROL ARM: Se les administrará una única dosis de placebo consistente en 0.05ml/kg de la jeringa preparada por el SF, que serán diluidos por parte de enfermería, en el quirófano ,en 500 ml de suero fisiológico. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Men and women aged 30-80 years
- Patients that undergo primary total hip replacement
- Diagnosis of primary hip osteoarthritis
- Accept and sign the informed consent
Exclusion criteria 12
- Patient undergoing corticosteroid treatment during the last 6 months before surgery
- Patients with a diagnosis of secondary osteoarthritis of the hip
- Patients with a diagnosis of hip fracture
- Allergic patients to Dexamethasone
- Patients who meet the criteria for malnutrition
- Patient with a diagnosis of Diabetes Mellitus (DM1 and DM2)
- Patients with Congestive Heart Failure (CHF)
- Patients with Chronic Renal Insufficiency (eGFR<60).
- Patients with peripheral venous insufficiency
- Patients diagnosed with previous lymphedema
- Patients with alterations of the cortico-adrenal axis
- Any condition that, in the clinical judgment of the researchers, may interfere with the object of the research
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Thigh circumference • Leg Perimeter • PCR value • IL-6 value
Secondary endpoints 1
- sex Age Body mass index Medical history Type of approach Physiotherapy start day Time of admission Postoperative visual analog scale (VAS) • Harris Functional Scale (HHS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Betamethasone Sodium Phosphate
SCP10332310 · ATC
- Active substance
- Betamethasone Sodium Phosphate
- Substance synonyms
- BETAMETHASONE DISODIUM PHOSPHATE
- Route of administration
- INTRAVENOUS PERFUSION USE
- Max daily dose
- 0.2 mg/Kg milligram(s)/kilogram
- Max total dose
- 0.2 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
—
SCP12712712 · ATC
- Route of administration
- INTRAVENOUS PERFUSION USE
- Max daily dose
- 5 ml millilitre(s)
- Max total dose
- 5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Universitari De Girona Doctor Josep Trueta
- Sponsor organisation
- Hospital Universitari De Girona Doctor Josep Trueta
- Address
- Avinguda De Franca S/n
- City
- Girona
- Postcode
- 17007
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Universitari De Girona Doctor Josep Trueta
- Contact name
- Principal Investigator
Public contact point
- Organisation
- Hospital Universitari De Girona Doctor Josep Trueta
- Contact name
- Principal Investigator
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 62 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2024-518133-28-00 | 5 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexametasone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Saline Solution | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-18 | Spain | Acceptable 2024-10-21
|
2024-10-21 |