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Preoperative High Dose Steroids for Liver Resection- Effect on Complications in the Immediate Postoperative Period (STEREO)

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ClinicalTrials.gov Identifier: NCT03403517
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Kristin Julia Steinthorsdottir, Rigshospitalet, Denmark

Brief Summary:

Background:

Several randomized clinical trials have shown beneficial effects of pre-operative glucocorticoids on post-operative complications.

Studies on the effects of glucocorticoids on the postoperative recovery after liver-resection show significantly lower markers of infection and liver damage, and some studies have shown a shorter hospital stay.

Studies on the effects in the immediate postoperative phase are lacking.

Methods: Randomized, double-blind, controlled trial evaluating incidence of postoperative complications in the immediate postoperative phase (and during admission) after open liver surgery. Participants are randomized to either active treatment (methylprednisolone 10 mg/kg) or control (8 mg dexamethasone), administered just prior to surgery.

All patients undergoing open liver resection at our institution are eligible. Included patients are stratified according to extent of surgery into minor (<3 segments) or major (≥3 segments) group.

Patients in major group participate in Substudy I (markers of endothelial damage).

Patients operated between January and July 2018 participate in Substudy II (delirium).


Condition or disease Intervention/treatment Phase
Complication, Postoperative Drug: Methylprednisolone Drug: Dexamethasone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: High Dose Steroids for Liver Resection - Effect on Complications and Endothelial Function in the Immediate Postoperative Phase - a Randomized, Doubleblind, Controlled Trial
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : January 1, 2021


Arm Intervention/treatment
Experimental: Methylprednisolone
10 mg/kg, single preoperative infusion
Drug: Methylprednisolone
10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery
Other Name: solu-medrol

Active Comparator: Dexamethasone
8 mg dexamethasone, single preoperative infusion
Drug: Dexamethasone
Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery




Primary Outcome Measures :
  1. Complications, post-anesthesia care unit (PACU) [ Time Frame: up to 24 hours ]
    Number of patients with any complication at any time, during stay in the PACU. Complications according to DASAIMS discharge criteria (modified Aldrete criteria)

  2. Substudy I: Markers of endothelial dysfunction [ Time Frame: post-operative days 0 to 3 ]
    Amount of endothelial markers (Syndecan-1, soluble thrombomodulin, SE-Selectin, vascular endothelial growth factor (VEGF) )

  3. Substudy II: Delirium [ Time Frame: 5 days ]
    Number of patients with post-operative cognitive impairment, according to 3-minute diagnostic confusion assessment method (3D-CAM)


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    any cause mortality

  2. Total complication rate [ Time Frame: 30 days ]
    any complications

  3. Hospital stay [ Time Frame: 3 months ]
    from operation to discharge

  4. PACU stay [ Time Frame: up to 24 hours ]
    from operation to discharge from PACU

  5. Pain at movement [ Time Frame: up to 24 hours ]
    every 60 minutes, during stay in PACU. Numeric Rating Scale (NRS 0-10)

  6. Pain, abdominal (postoperative) [ Time Frame: up to five days ]
    During admission, self reported. Numeric Rating Scale (NRS 0-10)

  7. Nausea [ Time Frame: up to five days ]
    During admission, self reported. (Light, none, moderate, heavy nausea)

  8. analgesic requirements [ Time Frame: up to five days ]
    All analgesics other than standard medication, during admission. From Medical record.

  9. antiemetic requirements [ Time Frame: up to five days ]
    All antiemetics other than standard medication, during admission. From Medical record.

  10. ALAT [ Time Frame: up to five days ]
    impact on ALAT (alanin-aminotransferase) post surgery

  11. Bilirubin [ Time Frame: up to five days ]
    impact on bilirubin post surgery

  12. INR [ Time Frame: up to five days ]
    impact on INR (International Normalized Ratio) post surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age minimum 18
  • Planned open liver resection (with or without combined ablation and/or
  • cholecystectomy)
  • Able to participate (self report pain/nausea)
  • Understands danish/english, or has an interpreter during admission
  • Signed consent form

Exclusion Criteria:

  • ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) procedure
  • Combined ventral herniotomy with implantation of mesh
  • Combined with operation on tumor in other organs
  • Insulin dependent diabetes
  • Current (<10 days) treatment with systemic glucocorticoids and/or immunosuppressive treatment (not including inhalations)
  • Epidural anesthesia not feasible
  • Pregnancy/breastfeeding
  • Allergy toward study medication
  • Inoperability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403517


Contacts
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Contact: kristin steinthorsdottir 31666112 kjs@dadlnet.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: kristin J steinthorsdottir, MD    004535451003    kristin.julia.steinthorsdottir.01@regionh.dk   
Contact: Eske K Aasvang, Dr.med    004535450802      
Sponsors and Collaborators
Rigshospitalet, Denmark
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Responsible Party: Kristin Julia Steinthorsdottir, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03403517    
Other Study ID Numbers: DEXLEV01
2017-002652-81 ( EudraCT Number )
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristin Julia Steinthorsdottir, Rigshospitalet, Denmark:
steroids
glucocorticoids
liver surgery
hepatectomy
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Dexamethasone
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents
Protective Agents