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Perioperative hydrocortisone treatment in pancreatoduodenectomy – randomised double-blinded placebo-controlled interventional trial (PD-HYDRA)
EU CTIS ID: 2024-517877-26-00
What this study is testing
1. to assess the efficacy of the treatment strategy with hydrocortisone infusions in comparison to placebo. Post-operative pancreatic fistula of grade B or worse within 90 days after surgery (POPF B/C)
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Patients with planned elective PD [pancreatoduodenectomy]; regardless of indication
- 2. Male or female patients aged ≥ 18 years without upper age limit
- 3. Written informed consent obtained according to international guidelines and local laws
- 4. Ability to understand the nature of the trial and the trial related procedures and to comply with them
You likely can't join if
- 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)
- 18. Focal or generalized epilepsy
- 19. Untreated overt hypothyroidism (Elevated Thyroid-Stimulating Hormone (TSH) levels and Low Free Thyroxine (FT4) levels)
- 2. Vaccination with live vaccine or live attenuated vaccine within the 4 weeks prior to surgery
- 20. Pheochromocytoma
- 21. Known or persistent abuse of medication, drugs or alcohol
See the full eligibility criteria
- 1. Patients with planned elective PD [pancreatoduodenectomy]; regardless of indication
- 2. Male or female patients aged ≥ 18 years without upper age limit
- 3. Written informed consent obtained according to international guidelines and local laws
- 4. Ability to understand the nature of the trial and the trial related procedures and to comply with them
- 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)
- 18. Focal or generalized epilepsy
- 19. Untreated overt hypothyroidism (Elevated Thyroid-Stimulating Hormone (TSH) levels and Low Free Thyroxine (FT4) levels)
- 2. Vaccination with live vaccine or live attenuated vaccine within the 4 weeks prior to surgery
- 20. Pheochromocytoma
- 21. Known or persistent abuse of medication, drugs or alcohol
- 22. Person who is in a relationship of dependence/employment with the sponsor or the investigator
- 23. Current or planned pregnancy, nursing period
- 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
- 3. Known hypersensitivity to the IMP (hydrocortisone or any of the excipients)
- 4. Participation in any other interventional clinical trial within the last 30 days prior to surgery
- 10. Inherited thromboembolic disease (Factor V Leiden Mutation, Prothrombin gene mutation, Protein C-, Protein S-, or antithrombin deficiency),
- 5. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registries and diagnostic trials is allowed
- 6. Patient without legal capacity
- 7. Uncontrolled arterial hypertension ESH Grade 3 (blood pressure remains at or above 180/110 mmHg despite treatment)
- 8. Chronic heart failure of New York Heart Association (NYHA) class III or IV
- 9. Glaucoma
- 25. WOCBP using hormonal contraceptives.
- 11. Myasthenia gravis
- 12. Active gastric or duodenal ulcer disease
- 13. Active diverticulitis
- 14. Active ulcerative colitis
- 15. Recent onset (6 months before randomisation) active deep venous thrombosis
- 16. Recent onset (6 months before randomisation) thromboembolic disease
- 17. GFR < 30 ml/h/1.73 m² as estimated by CKD-EPI Creatinine Equation (2021) (www.kidney.org/professionals/gfr_calculator)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.