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Phase 4 N=174 Randomized Quadruple-blind Prevention

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

Complication, Postoperative

Enrolled (actual)
174
Serious AEs
1.7%
Results posted
Jan 2021
Primary outcome: Primary: Complications, Post-anesthesia Care Unit (PACU) — 51; 58 Participants — p=0.213

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Methylprednisolone (Drug); Dexamethasone (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Rigshospitalet, Denmark
Primary completion
Aug 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Complications, Post-anesthesia Care Unit (PACU)
51; 58 0.213
PRIMARY
Substudy I: Markers of Endothelial Dysfunction
PRIMARY
Substudy II: Delirium
SECONDARY
Mortality
0; 0
SECONDARY
Total Complication Rate
19; 19 >0.999
SECONDARY
Hospital Stay
98; 102 0.160
SECONDARY
PACU Stay
203; 186
SECONDARY
Pain at Movement
SECONDARY
Pain, Abdominal (Postoperative)
SECONDARY
Nausea
SECONDARY
Analgesic Requirements
SECONDARY
Antiemetic Requirements
SECONDARY
ALAT
SECONDARY
Bilirubin
SECONDARY
INR

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).

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03403517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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