Supplemental corticosteroids in cirrhotic hypotensive patients with suspicion of sepsis - SCOTCH-trial

niversity Hospitals Leuven0 个研究点目标入组 356 人开始时间: 2013年9月3日最近更新: 2016年8月16日

试验速览

暂无简介。

•All patients with known or recently diagnosed cirrhosis who
•a) are admitted to the ICU because of persistent hypotension or
•b) develop persistent hypotension while admitted to the ICU, in both cases despite adequate fluid resuscitation and with need for low-dose norepinephrine, are eligible for study entry.
•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 280
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 76

•Age < 18 or = 80 years
•Patients receiving any vasopressor medication for more than 24 h prior to administration of study drug
•Patients with known hypoadrenalism
•Active GI bleeding (unless controlled for >72 hours) or hemorrhagic shock.
•Cardiogenic shock or severe cardiac dysfunction (CI <2 l/min/ m2)
•Active uncontrolled hepatitis B infection
•HIV infection
•Evidence of current malignancy (except hepatocellular carcinoma within transplant criteria or non-melanocytic skin cancer)
•Therapy with any corticosteroid in the last 3 months
•Patients who received etomidate within the past 3 days
•Severe acute alcoholic hepatitis (biopsy proven)
•Chronic hemodialysis
•Severe chronic heart disease (NYHA class III or IV)
•Severe chronic obstructive pulmonary disease (GOLD III or IV)
•Severe psychiatric disorder
•Child-Pugh score C14 -15
•SOFA score > 12 points at inclusion
•Pregnant or breastfeeding women
•Contraindications for systemic steroids
•Refusal to consent

发起方

niversity Hospitals Leuven