Effects of high dose steroids on complications after liver resection -a randomized, double-blind, controlled trial

High dose steroids in liver resection – effects on complications and endothelial function in the immediate postoperative phase. A randomized, double-blind, controlled trial - STEREO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002652-81-DK

Enrollment

174

Registered

2017-06-30

Start date

2017-10-17

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications after liver resections - due to liver disease (mainly primary liver cancer and metastases) MedDRA version: 20.0 Level: LLT Classification code 10036278 Term: Postoperative complications NOS System Organ Class: 100000020453

Interventions

Trade Name: solu-medrol Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE Concentration unit: mg m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age at or above 18 years Open liver resection, including combined ablation and/or cholecystectomy in the study period Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 74 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effects of high dose steroids on complications after liver resection;Secondary Objective: To investigate the effects of high dose steroids on endothelial function, myocardial injury and cerebral function after liver surgery;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;Timepoint(s) of evaluation of this end point: I. 24 hours II. 48 hours III. 48 hours IV. 24 hours	—

Measure

Time frame

Main Objective: To investigate the effects of high dose steroids on complications after liver resection;Secondary Objective: To investigate the effects of high dose steroids on endothelial function, myocardial injury and cerebral function after liver surgery;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;Timepoint(s) of evaluation of this end point: I. 24 hours II. 48 hours III. 48 hours IV. 24 hours

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Secondary

Measure	Time frame
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 ;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	—

Measure

Time frame

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 ;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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Countries

Denmark

Contacts

Public ContactKristin Julia Steinthorsdottir

Rigshospitalet

004535451003

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 22, 2026