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

CHU de Nantes0 个研究点目标入组 1,222 人开始时间: 2017年4月21日最近更新: 2020年9月15日

试验速览

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•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
•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

•-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)

发起方