Conservative vs. Liberal Approach to fluid therapy of Septic Shock in Intensive Care - Classic

Dept. of Intensive Care, Copenhagen University Hospital, Rigshospitalet0 个研究点目标入组 150 人开始时间: 2014年5月6日最近更新: 2015年12月28日

适应症

试验速览

暂无简介。

•Adult intensive care patients (age = 18 years) with sepsis defined as 2 of 4 SIRS criteria fulfilled within 24 hours and suspected or confirmed site of infection or positive blood culture
•Suspected or confirmed circulatory impairment (hypotension/hypoperfusion/hypovolemia) for at least 6 hours and no more than 12 hours including the hours preceding ICU admission
•At least 30 ml/kg IBW fluid (colloids, crystalloids or blood products) given in the last 6 hours
•Shock (defined as ongoing infusion of norepinephrine (any dose) to maintain blood pressure)
•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 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•Use of any form of renal replacement therapy (RRT) or RRT deemed imminent by the ICU doctor, i.e. RRT will be initiated within 6 hours.
•Severe hyperkalemia (p-K > 6 mM).
•Plasma creatinine > 350 µmol/l.
•invasively ventilated with FiO2 > 0.80 and PEEP > 10 mmHg.
•Life-threatening bleeding.
•Kidney or liver transplant during current admission.
•Burns > 10% BSA.
•Previously enrolled in the CLASSIC trial and has finished the 90 day observation period
•Withdrawal of active therapypatients for whom it has been decided not to give full life support including mechanical ventilation and RRT.
•Consent not obtainable.

发起方

Dept. of Intensive Care, Copenhagen University Hospital, Rigshospitalet