Clinical trial • Phase II/III • Gastroenterology
HYDROCORTISONE for Pancreatic resection
Phase II/III trial of HYDROCORTISONE for Pancreatic resection.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Pancreatic resection
- Trial Stage
- Phase II/III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 20-12-2024
- First CTIS Authorization Date
- 07-03-2025
Trial design
Randomised, active: hydrocortison pfizer 100 mg (hydrocortisone) solution for injection/infusion (route: infusion); comparator/placebo: sodium chloride solution for infusion. dose/schedule not specified in the provided data.-controlled Phase II/III trial across 14 sites in Germany.
- Randomised
- Yes
- Comparator
- Active: HYDROCORTISON Pfizer 100 mg (hydrocortisone) solution for injection/infusion (route: infusion); Comparator/placebo: SODIUM CHLORIDE solution for infusion. Dose/schedule not specified in the provided data.
- Target Sample Size
- 614
- Trial Duration For Participant
- 365
Eligibility
Recruits 614 Vulnerable populations not selected. "Written informed consent obtained according to international guidelines and local laws" is required; "Patient without legal capacity" is listed as an exclusion..
- Pregnancy Exclusion
- 23. Current or planned pregnancy, nursing period
- Vulnerable Population
- Vulnerable populations not selected. "Written informed consent obtained according to international guidelines and local laws" is required; "Patient without legal capacity" is listed as an exclusion.
Inclusion criteria
- {"criterion_text":"- 1. Patients with planned elective PD [pancreatoduodenectomy]; regardless of indication"}
- {"criterion_text":"- 2. Male or female patients aged ≥ 18 years without upper age limit"}
- {"criterion_text":"- 3. Written informed consent obtained according to international guidelines and local laws"}
- {"criterion_text":"- 4. Ability to understand the nature of the trial and the trial related procedures and to comply with them"}
Exclusion criteria
- {"criterion_text":"- 1. Other perioperatively planned or pre-existing medication with a glucocorticoid in a dose of more than 30mg hydrocortisone-equivalent per day (e.g. for PONV prophylaxis, autoimmune diseases)"}
- {"criterion_text":"- 18. Focal or generalized epilepsy"}
- {"criterion_text":"- 19. Untreated overt hypothyroidism (Elevated Thyroid-Stimulating Hormone (TSH) levels and Low Free Thyroxine (FT4) levels)"}
- {"criterion_text":"- 2. Vaccination with live vaccine or live attenuated vaccine within the 4 weeks prior to surgery"}
- {"criterion_text":"- 20. Pheochromocytoma"}
- {"criterion_text":"- 21. Known or persistent abuse of medication, drugs or alcohol"}
- {"criterion_text":"- 22. Person who is in a relationship of dependence/employment with the sponsor or the investigator"}
- {"criterion_text":"- 23. Current or planned pregnancy, nursing period"}
- {"criterion_text":"- 24. For women of childbearing potential failure to use one of the following safe methods of contraception: abstinence from sexual intercourse, female condoms, diaphragm or coil, each used in combination with spermicides; copper intra-uterine device"}
- {"criterion_text":"- 3. Known hypersensitivity to the IMP (hydrocortisone or any of the excipients)"}
- {"criterion_text":"- 4. Participation in any other interventional clinical trial within the last 30 days prior to surgery"}
- {"criterion_text":"- 10. Inherited thromboembolic disease (Factor V Leiden Mutation, Prothrombin gene mutation, Protein C-, Protein S-, or antithrombin deficiency),"}
- {"criterion_text":"- 5. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registries and diagnostic trials is allowed"}
- {"criterion_text":"- 6. Patient without legal capacity"}
- {"criterion_text":"- 7. Uncontrolled arterial hypertension ESH Grade 3 (blood pressure remains at or above 180/110 mmHg despite treatment)"}
- {"criterion_text":"- 8. Chronic heart failure of New York Heart Association (NYHA) class III or IV"}
- {"criterion_text":"- 9. Glaucoma"}
- {"criterion_text":"- 25. WOCBP using hormonal contraceptives."}
- {"criterion_text":"- 11. Myasthenia gravis"}
- {"criterion_text":"- 12. Active gastric or duodenal ulcer disease"}
- {"criterion_text":"- 13. Active diverticulitis"}
- {"criterion_text":"- 14. Active ulcerative colitis"}
- {"criterion_text":"- 15. Recent onset (6 months before randomisation) active deep venous thrombosis"}
- {"criterion_text":"- 16. Recent onset (6 months before randomisation) thromboembolic disease"}
- {"criterion_text":"- 17. GFR < 30 ml/h/1.73 m² as estimated by CKD-EPI Creatinine Equation (2021) (www.kidney.org/professionals/gfr_calculator)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Post-operative pancreatic fistula of grade B or worse within 90 days after surgery (POPF B/C)","definition_or_measurement_approach":"Post-operative pancreatic fistula of grade B or worse within 90 days after surgery (POPF B/C)"}
Secondary endpoints
- {"endpoint_text":"- 2. POPF B/C within 90 days after pancreatoduodenectomy","definition_or_measurement_approach":"POPF B/C within 90 days after pancreatoduodenectomy"}
- {"endpoint_text":"- 3. Overall survival within one year (OS)","definition_or_measurement_approach":"Overall survival within one year"}
- {"endpoint_text":"- 4. Grade IIIb or worse complication in the Clavien-Dindo Classification (CDC) within 90 days after surgery (CDC IIIb+)","definition_or_measurement_approach":"CDC grade IIIb or worse within 90 days after surgery"}
- {"endpoint_text":"- 6. Grade C postpancreatectomy haemorrhage within 90 days after surgery (PPH C)","definition_or_measurement_approach":"PPH C within 90 days after surgery"}
- {"endpoint_text":"- 7. Grade B or worse delayed gastric emptying within 90 days after surgery (DGE B/C)","definition_or_measurement_approach":"DGE B/C within 90 days after surgery"}
- {"endpoint_text":"- 8. Grade B or worse bile leak within 90 days after surgery (BL B/C)","definition_or_measurement_approach":"BL B/C within 90 days after surgery"}
- {"endpoint_text":"- 9. Grade B or worse chyle leak within 90 days after surgery (CL B/C)","definition_or_measurement_approach":"CL B/C within 90 days after surgery"}
- {"endpoint_text":"- 10. Completion pancreatectomy within 90 days after surgery","definition_or_measurement_approach":"Occurrence of completion pancreatectomy within 90 days after surgery"}
- {"endpoint_text":"- 11. Surgical site infection within 90 days after surgery","definition_or_measurement_approach":"Surgical site infection within 90 days after surgery"}
- {"endpoint_text":"- 12. Pneumonia within 90 days after first dose","definition_or_measurement_approach":"Pneumonia within 90 days after first dose"}
- {"endpoint_text":"- 13. Cholangitis within 90 days after first dose","definition_or_measurement_approach":"Cholangitis within 90 days after first dose"}
- {"endpoint_text":"- (Serious) adverse events ((S)AE)","definition_or_measurement_approach":"(Serious) adverse events as reported"}
- {"endpoint_text":"- 5. Grade B or worse postpancreatectomy acute pancreatitis within 90 days after surgery (PPAP B/C)","definition_or_measurement_approach":"PPAP B/C within 90 days after surgery"}
Recruitment
- Planned Sample Size
- 614
- Recruitment Window Months
- 56
- Consent Approach
- Written informed consent obtained according to international guidelines and local laws. Subject information and informed consent form documents are listed (L1_SIS and ICF Hauptstudie). Minors/assent not applicable because inclusion requires age ≥ 18 years; patients without legal capacity are excluded.
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 614
Germany
- Earliest CTIS Part Ii Submission Date
- 20-02-2025
- Latest Decision Or Authorization Date
- 10-07-2025
- Processing Time Days
- 140
- Number Of Sites
- 14
- Number Of Participants
- 614
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Chirurgische Klinik
- Principal Investigator Name
- Johann Pratschke
- Principal Investigator Email
- johann.pratschke@charite.de
- Contact Person Name
- Johann Pratschke
- Contact Person Email
- johann.pratschke@charite.de
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Klinik und Lehrstuhl für Allgemein-, Viszeral- und Transplantationschirurgie
- Principal Investigator Name
- Georg Wiltberger
- Principal Investigator Email
- gwiltberger@ukaachen.de
- Contact Person Name
- Georg Wiltberger
- Contact Person Email
- gwiltberger@ukaachen.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Chirurgie
- Principal Investigator Name
- Ulrich Wellner
- Principal Investigator Email
- Ulrich.Wellner@uksh.de
- Contact Person Name
- Ulrich Wellner
- Contact Person Email
- Ulrich.Wellner@uksh.de
- Site Name
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Department Name
- Klinik und Poliklinik für Chirurgie
- Principal Investigator Name
- Daniel Reim
- Principal Investigator Email
- daniel.reim@tum.de
- Contact Person Name
- Daniel Reim
- Contact Person Email
- daniel.reim@tum.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Klinik für Allgemein- Viszeral und Transplantationschirurgie
- Principal Investigator Name
- Frank Pianka
- Principal Investigator Email
- Frank.Pianka@med.uni-heidelberg.de
- Contact Person Name
- Frank Pianka
- Contact Person Email
- Frank.Pianka@med.uni-heidelberg.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Allgemein- und Viszeralchirurgie
- Principal Investigator Name
- Dietrich Ruess
- Principal Investigator Email
- dietrich.ruess@uniklinik-freiburg.de
- Contact Person Name
- Dietrich Ruess
- Contact Person Email
- dietrich.ruess@uniklinik-freiburg.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Klinik und Poliklinik für Chirurgie
- Principal Investigator Name
- Stefan Brunner
- Principal Investigator Email
- stefan.brunner@ukr.de
- Contact Person Name
- Stefan Brunner
- Contact Person Email
- stefan.brunner@ukr.de
- Site Name
- St. Josef-Hospital
- Department Name
- Klinik für Allgemein- und Viszeralchirurgie
- Principal Investigator Name
- Orlin Belyaev
- Principal Investigator Email
- orlin.belyaev@kklbo.de
- Contact Person Name
- Orlin Belyaev
- Contact Person Email
- orlin.belyaev@kklbo.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Klinik für Allgemeine, Viszeral-, Transplantations-, Gefäß- und Thoraxchirurgie
- Principal Investigator Name
- Jens Werner
- Principal Investigator Email
- Jens.Werner@med.uni-muenchen.de
- Contact Person Name
- Jens Werner
- Contact Person Email
- Jens.Werner@med.uni-muenchen.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Klinik für Allgemein-, Viszeral- und Thoraxchirurgie
- Principal Investigator Name
- Faik Uzunoglu
- Principal Investigator Email
- f.uzunoglu@uke.de
- Contact Person Name
- Faik Uzunoglu
- Contact Person Email
- f.uzunoglu@uke.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Allgemein-, Viszeral- und Kinderchirurgie
- Principal Investigator Name
- Florian Boesch
- Principal Investigator Email
- florian.boesch@med.uni-goettingen.de
- Contact Person Name
- Florian Boesch
- Contact Person Email
- florian.boesch@med.uni-goettingen.de
- Site Name
- Justus-Liebig-Universitaet Giessen
- Department Name
- Klinik für Allgemein-, Viszeral-, Thorax-, und Transplantationschirurgie
- Principal Investigator Name
- Martin Reichert
- Principal Investigator Email
- Martin.Reichert@chiru.med.uni-giessen.de
- Contact Person Name
- Martin Reichert
- Contact Person Email
- Martin.Reichert@chiru.med.uni-giessen.de
- Site Name
- Heidelberg University
- Department Name
- Chirurgische Klinik
- Principal Investigator Name
- Christoph Reissfelder
- Principal Investigator Email
- Christoph.Reissfelder@umm.de
- Contact Person Name
- Christoph Reissfelder
- Contact Person Email
- Christoph.Reissfelder@umm.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik für Allgemein-, Viszeral-, Tumor- und Transplantationschirurgie
- Principal Investigator Name
- Christiane Bruns
- Principal Investigator Email
- christiane.bruns@uk-koeln.de
- Contact Person Name
- Christiane Bruns
- Contact Person Email
- christiane.bruns@uk-koeln.de
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Third parties
- {"country":"Germany","full_name":"Medical Center - University Of Freiburg","duties_or_roles":"Central pharmacy, manufacturing and distribution of IMP","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Medical Center - University Of Freiburg","duties_or_roles":"codes: 1,11,12,5,6,7,8","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Medical Center - University Of Freiburg","duties_or_roles":"Central phatology","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- HYDROCORTISON Pfizer 100 mg sine Pulver und Lösungsmittel zur Herstellung einer Injektions- oder Infusionslösung
- Active Substance
- HYDROCORTISONE
- Modality
- Small molecule
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- Marketing authorisation info present (marketingAuthNumber: 6177448.00.00; authorisationCountryCode: DE)
- Starting Dose
- 100 mg
- Maximum Dose
- Max daily dose 300 mg; max total dose 900 mg
- Investigational Product Name
- SODIUM CHLORIDE
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- Product record present (euMpNumber: SUB12581MIG; marketingAuthNumber: - )
- Maximum Dose
- Max daily volume 300 ml; max total volume 900 ml
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