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Methylprednisolone and N- aceltylcisteine in hepatic resections

MEthylprednisoloneNacinHepatIcResections “MENHIR” - MENHIR

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-003213-34-IT
Enrollment
Unknown
Registered
2012-11-23
Start date
2012-11-13
Completion date
Unknown
Last updated
2014-01-27

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

Conditions

patients candidate to liver resection MedDRA version: 14.1 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Trade Name: SOLUMEDROL*IM IV FL 500MG+F8ML Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE CAS Number: 2375-03-3 Concentrati

Sponsors

ISTITUTO CLINICO HUMANITAS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Any sex, any race, any ethnicity Age > 18 Primary and secondary liver tumors Normal renal function Anticipated Pringle’s length > 30 minutes Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Renal failure of any grade ASA 4 Associate major surgery Intraoperative bleeding > 1500 ml Allergy to NAC or MET

Design outcomes

Primary

MeasureTime frame
Secondary Objective: Secondary objective of the study is whether the reduction of ischemia-reperfusion injury results in: lower incidence of postoperative liver failure, improvement of postoperative liver function, and reduction of blood components transfusions;Primary end point(s): The primary endpoint of the study is the modulation of the IR injury made by NAC and/or MET in patients undergoing liver surgery. For this purpose a decrease of 100 UI/L of AST and ALT is expected compared with placebo;Timepoint(s) of evaluation of this end point: at the end of the operation, as well as in postoperative day 1, 3, 5 and 7;Main Objective: The primary objective of the study is to assess the real efficacy of MET and NAC in reducing the secondary damage from ischemia reperfusion injury in liver resection—

Secondary

MeasureTime frame
Secondary end point(s): evaluation difference in total bilirubin;Timepoint(s) of evaluation of this end point: at the end of the operation, as well as in postoperative day 1, 3, 5 and 7—

Countries

Italy

Contacts

Public ContactResponsabile Chirurgia Epatica

Istituto Clinico Humanitas

guido.torzilli@humanitas.it02/82244083

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026