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

NCT03403517 | Completed Phase 4 Results DMC

• 2 other identifiers: DEXLEV012017-002652-81
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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).

Conditions

Complication, Postoperative

Keywords

steroids; glucocorticoids; liver surgery; hepatectomy

Outcome Measures

Primary Outcomes (3)

• Complications, Post-anesthesia Care Unit (PACU)

  Number of patients with any complication at any time, during stay in the PACU. Complications according to DASAIMS discharge criteria (modified Aldrete criteria)

  up to 24 hours

• Substudy I: Markers of Endothelial Dysfunction

  Amount of endothelial markers (Syndecan-1, soluble thrombomodulin, SE-Selectin, vascular endothelial growth factor (VEGF) )

  post-operative days 0 to 3

• Substudy II: Delirium

  Number of patients with post-operative cognitive impairment, according to 3-minute diagnostic confusion assessment method (3D-CAM)

  5 days

Secondary Outcomes (12)

• Mortality

  30 days

• Total Complication Rate

  30 days

• Hospital Stay

  3 months

• PACU Stay

  up to 24 hours

• Pain at Movement

  up to 24 hours

Study Arms (2)

Methylprednisolone

EXPERIMENTAL

10 mg/kg, single preoperative infusion

Drug: Methylprednisolone

Dexamethasone

ACTIVE COMPARATOR

8 mg dexamethasone, single preoperative infusion

Drug: Dexamethasone

Interventions

Methylprednisolone DRUG

10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery

Also known as: solu-medrol

Methylprednisolone

Dexamethasone DRUG

Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery

Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Steinthorsdottir KJ, Awada HN, Schultz NA, Larsen PN, Hillingso JG, Jans O, Kehlet H, Aasvang EK. Preoperative high-dose glucocorticoids for early recovery after liver resection: randomized double-blinded trial. BJS Open. 2021 Jul 6;5(5):zrab063. doi: 10.1093/bjsopen/zrab063.

  PMID: 34480563 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Methylprednisolone; Methylprednisolone Hemisuccinate; Dexamethasone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Kristin steinthorsdottir
• Organization: Rigshospitalet

kjs@dadlnet.dk

004531666112

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 18, 2018
• Study Start: December 11, 2017
• Primary Completion: August 28, 2020
• Study Completion: September 28, 2020
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12

Locations

DK (1)