Clinical trial • Phase IV • Other

Methylprednisolone for Major surgery: Robotic-assisted laparoscopic radical prostatectomy | Major peripheral vascular surgery (femoral–popliteal bypass, tibial bypass, profundaplasty) | Coronary artery bypass grafting (on-pump and off-pump) | Thoracoscopic lung resection | Laparoscopic colorectal surgery | Minimally invasive valve repair or replacement

Phase IV trial of Methylprednisolone for Major surgery: Robotic-assisted laparoscopic radical prostatectomy | Major peripheral vascular surgery (femoral–p…

Overview

Trial Therapeutic Area
Other
Trial Disease
Major surgery: Robotic-assisted laparoscopic radical prostatectomy | Major peripheral vascular surgery (femoral–popliteal bypass, tibial bypass, profundaplasty) | Coronary artery bypass grafting (on-pump and off-pump) | Thoracoscopic lung resection | Laparoscopic colorectal surgery | Minimally invasive valve repair or replacement
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
02-10-2024
First CTIS Authorization Date
22-10-2024

Trial design

Sodium Chloride 0.9% Intravenous Infusion (placebo) — intravenous infusion; product maximum total 200 ml reported; used as comparator/placebo to test product Solu-Medrol (methylprednisolone) 125 mg powder for injection (test product). Exact dose and schedule per arm not specified in provided data.-controlled Phase IV trial across 1 site in Belgium.

Comparator
Sodium Chloride 0.9% Intravenous Infusion (placebo) — intravenous infusion; product maximum total 200 ml reported; used as comparator/placebo to test product Solu-Medrol (methylprednisolone) 125 mg powder for injection (test product). Exact dose and schedule per arm not specified in provided data.
Target Sample Size
674

Eligibility

Recruits 674 Vulnerable populations not selected. Exclusion criterion: 'Lack of informed consent or inability to give informed consent' indicates participants must be able to provide informed consent. Assent handling or specific vulnerable-population consent procedures not specified..

Vulnerable Population
Vulnerable populations not selected. Exclusion criterion: 'Lack of informed consent or inability to give informed consent' indicates participants must be able to provide informed consent. Assent handling or specific vulnerable-population consent procedures not specified.

Inclusion criteria

  • {"criterion_text":"- Aged 60 years or older"}
  • {"criterion_text":"- Scheduled for a complex major surgical procedure"}

Exclusion criteria

  • {"criterion_text":"- Lack of informed consent or inability to give informed consent"}
  • {"criterion_text":"- Severe PONV, needing corticosteroids as PONV prophylaxis"}
  • {"criterion_text":"- Urgent, not elective surgery"}
  • {"criterion_text":"- Hypersensitivity or known allergic reaction to methylprednisolone"}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- 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 endpoints

  • {"endpoint_text":"- Postoperative muscle strength","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Postoperative muscle function","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Postoperative lung function","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Cognitive status (S5Q)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Fatigue questionnaire (Chalder fatigue questionnaire)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- QoR-15 questionnaire","definition_or_measurement_approach":""}
  • {"endpoint_text":"- EQ5D","definition_or_measurement_approach":""}
  • {"endpoint_text":"- NRS pain score 0-10","definition_or_measurement_approach":""}
  • {"endpoint_text":"- PONV","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Biochemical analyses and markers of coagulation","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
674
Recruitment Window Months
40
Consent Approach
Participants must provide informed consent; exclusion criterion states 'Lack of informed consent or inability to give informed consent'. Subject information and informed consent forms are listed among study documents (ICF group A V3 and ICF group B V5). Languages of consent forms and assent procedures not specified.

Geography

Total Number Of Sites
1
Total Number Of Participants
674

Belgium

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
22-10-2024
Processing Time Days
55
Number Of Sites
1
Number Of Participants
674

Sites

Site Name
Ziekenhuis Oost Limburg
Department Name
Critical care department
Contact Person Name
Steven Thiessen
Contact Person Email
steven.thiessen@zol.be

Sponsor

Primary sponsor

Full Name
Ziekenhuis Oost Limburg
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
Solu-Medrol S.A.B. (= Sine Alcohol Benzylicus) 125 mg Poeder en oplosmiddel voor oplossing voor injectie (methylprednisolon)
Active Substance
Methylprednisolone
Modality
Small molecule
Routes Of Administration
Intravenous administration
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
500 mg
Investigational Product Name
Sodium Chloride 0.9% Intravenous Infusion
Active Substance
Sodium chloride
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
200 ml

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