E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Complications after liver resections - due to liver disease (mainly primary liver cancer and metastases) |
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E.1.1.1 | Medical condition in easily understood language |
Complications after liver surgery |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036278 |
E.1.2 | Term | Postoperative complications NOS |
E.1.2 | System Organ Class | 100000020453 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the effects of high dose steroids on complications after liver resection |
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E.2.2 | Secondary objectives of the trial |
To investigate the effects of high dose steroids on endothelial function, myocardial injury and cerebral function after liver surgery |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
I. High dose steroids in liver resection - effects on complications in the immediate postoperative phase. Objective: Investigate whether high-dose steroids reduce the number of patients with complications in the post-anesthesia care unit (PACU) II. High dose steroids in major liver resection - effects on endothelial function Objective: Investigate whether high-dose steroids reduce markers of endothelial glycocalyx shedding, endothelial cell injury, activation, and permeability. III. High dose steroids in liver resection - effects on myocardial injury Objective: Investigate whether high-dose steroids reduce markers of myocardial injury IV. High dose steroids in liver resection - effects on cerebral function (delirium and emotional behavior) Objective: Investigate whether high-dose steroids affects number of patients with signs of delirium in the PACU |
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E.3 | Principal inclusion criteria |
Age at or above 18 years Open liver resection, including combined ablation and/or cholecystectomy in the study period Signed informed consent |
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E.4 | Principal exclusion criteria |
• Associated liver partition and portal vein ligation (ALPPS) procedure • Simultaneous ventral herniotomy with implantation of mesh • Simultaneous operation for primary tumor in other organs • Insuline dependent diabetes • Ongoing (< 10 days) treatment with systemic corticosteroids/immunosuppressive therapy (except inhalations) • Pregnancy/Breastfeeding • Allergies towards study medication
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E.5 End points |
E.5.1 | Primary end point(s) |
I. Number of patients with complications in the post-anesthesia care unit (PACU) II. Level of biomarkers of endothelial glycocalyx, endothelial cell injury, activation, and permeability, III. Level of biomarkers of injury IV. Delirium score in the PACU |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
I. 24 hours II. 48 hours III. 48 hours IV. 24 hours |
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E.5.2 | Secondary end point(s) |
1. Lenght of stay (LOS) PACU 2. LOS Hospital 3. 30-day mortality 4. 30-day morbidity (liver failure, ascites, intraabdominal bleeding, cholascos, pleural effusion, lung emboli, deep vein thrombosis, acute myocardial infarction, transient cerebral ischemia, apoplexia, infections (pneumonia, urinary tract infection, sepsis, wound infection) 5. Discharges core at arrival to, and departure from the PACU 6. Complications in the ward the first 24 hours after surgery 7. Pain during admission (self-reported, up to 5 days after surgery) 8. Nausea during admission (self-reported, up to 5 days after surgery) 9. Use of analgesics other than standard medication during admission, up to 5 days after surgery 10. Use of anti-emetics other than standard medication during admission, up to 5 days after surgery 11. Markers of liver function/damage
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1+2. Until discharge (from PACU and hospital) 3+4. 30 days post-surgery 5+6. 24 hours post-surgery 7-11. 5 days post-surgery
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |