Overview
Sponsor-declared trial summary
Major surgery: robotic assisted laparoscopic radical prostatectomies
The main objective of this prospective trial is to evaluate the effect of moderate dose corticosteroids on early post-operative outcome, focusing on muscle weakness, in elderly patients (≥60 years) undergoing complex major surgery.
Key facts
- Sponsor
- Ziekenhuis Oost Limburg
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Decision date (initial)
- 2024-10-22
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517602-28-00
- EudraCT number
- 2021-004737-37
- ClinicalTrials.gov
- NCT05220319
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The main objective of this prospective trial is to evaluate the effect of moderate dose corticosteroids on early post-operative outcome, focusing on muscle weakness, in elderly patients (≥60 years) undergoing complex major surgery.
Secondary objectives 1
- We will also monitor secondary outcomes related to early recovery after surgery and we will investigate the effect on systemic inflammation and coagulation; functional and clinical outcomes; biochemical analysis and markers of coagulation.
Conditions and MedDRA coding
Major surgery: robotic assisted laparoscopic radical prostatectomies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10042613 | Surgical and medical procedures | 25 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Aged 60 years or older
- Scheduled for a complex major surgical procedure
Exclusion criteria 6
- Lack of informed consent or inability to give informed consent
- Severe PONV, needing corticosteroids as PONV prophylaxis
- Urgent, not elective surgery
- Hypersensitivity or known allergic reaction to methylprednisolone
- Preoperative use of steroids: including, but not limited to, the use of corticosteroids < 4 weeks before surgery of at least 4 mg methylprednisolone equivalents; excluding inhalational steroids
- Preexisting muscle disease: including, but not limited to, Steinert's disease, amyotrophic lateral sclerosis (ALS), Duchenne dystrophy, amputation of dominant arm or hand
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Postoperative muscle strength
Secondary endpoints 9
- Postoperative muscle function
- Postoperative lung function
- Cognitive status (S5Q)
- Fatigue questionnaire (Chalder fatigue questionnaire)
- QoR-15 questionnaire
- EQ5D
- NRS pain score 0-10
- PONV
- Biochemical analyses and markers of coagulation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD859203 · Product
- Active substance
- Methylprednisolone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB04 — METHYLPREDNISOLONE
- Marketing authorisation
- BE133847
- MA holder
- PFIZER S.A.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Sodium Chloride 0.9% Intravenous Infusion
PRD2128241 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 ml millilitre(s)
- Max total dose
- 200 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- PL 08828/0034
- MA holder
- FRESENIUS KABI LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ziekenhuis Oost Limburg
- Sponsor organisation
- Ziekenhuis Oost Limburg
- Address
- Synaps Park 1
- City
- Genk
- Postcode
- 3600
- Country
- Belgium
Scientific contact point
- Organisation
- Ziekenhuis Oost Limburg
- Contact name
- Clinical Trial Unit
Public contact point
- Organisation
- Ziekenhuis Oost Limburg
- Contact name
- Clinical Trial Unit
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 674 | 1 |
| 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 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2024-517602-28-00 _ Protocol CORTERAS V4 | 4 |
| Recruitment arrangements (for publication) | 2024-517602-28-00 _ Study Population | 1 |
| Subject information and informed consent form (for publication) | 2024-517602-28-00 _ ICF group A V3 | 1 |
| Subject information and informed consent form (for publication) | 2024-517602-28-00 _ ICF group B V5 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPc methylprednisolone | 1 |
| Synopsis of the protocol (for publication) | 2024-517602-28-00 _ Synopsis protocol | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-02 | Belgium | Acceptable 2024-10-21
|
2024-10-22 |