Effects of perioperative administration of dexamethasone on postoperative complications and mortality after non-cardiac major surgery : a randomized, multicentre, double blind, study

Phase 1

• Conditions: non-cardiac major surgery; MedDRA version: 20.0Level: PTClassification code 10042609Term: SurgerySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2017-000442-21-FR
• Lead Sponsor: CHU de Nantes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-21
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1222

Inclusion Criteria

Major surgery (> 90 minutes and realized under general anesthesia) of the abdomen, pelvis, thorax, face/neck, vascular surgery in a patient older than 65 years
Or
Major surgery (> 90 minutes and realized under general anesthesia) of the abdomen, pelvis, thorax, face/neck, vascular surgery in a patient older than 50 years and presenting one of the following criteria
oPresence of a defined risk factor for cardiac or respiratory disease (exercise tolerance equivalent to 6 metabolic equivalents or less)
oMedical history of stroke
oModerate to severe renal impairment (clearance of creatinine = 30 mll/L)
oActive smoking
oAveraged observed blood losses over 500 ml
oEmergency surgery

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Pregnant women, Minors, Adults under guardianship or trusteeship
-Treatment with systemic corticosteroids at a dose > 5 mg.day-1 of equivalent prednisolone in the previous 3 months
-Patients with chronic renal failure (clearance of creatinine < 10 ml/min)
-Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 1 month
-Patient with preoperative shock (defined by the need for vasoactive drugs before surgery)
-Acute Pulmonary edema in the last 7 days
-Active bacterial or viral infection
-Allergy to the intravenous formulation of dexamethasone
-Uncontrolled psychotic disorder (acute or chronical)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified