Heparin Anticoagulation to improve Outcomes in septic shock :The HALO International phase II RCT. - HALO

HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS0 个研究点目标入组 500 人开始时间: 2019年4月18日最近更新: 2019年12月10日

适应症

试验速览

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•1. = 18 years of age
•2. Refractory hypotension documented within 18 hours prior to enrolment that requires the institution and ongoing use of vasopressor agents, (phenylephrine, norepinephrine, vasopressin, epinephrine, midodrine or dopamine >5 mcg/kg/min) at the time of enrolment. Refractory hypotension is defined as a systolic blood pressure (SBP) less than 90 mm Hg, or a systolic blood pressure more than 30 mm Hg below baseline, or a mean arterial pressure (MAP) less than 65 mm Hg and receipt of = 2 litres of intravenous fluid for the treatment of hypotension.
•3. At least 1 other new organ dysfunction (in addition to refractory hypotension), defined by the following:
•a.) Creatinine =1.5x the known baseline creatinine, or = 26.5 µmol/l increase or <0.5 ml/kg of urine output for 6-12 hours according to the KDIGO [Kidney Disease improving Global Outcomes (KDiGO)] guideline definition of acute kidney injury.
•b.) Need for invasive mechanical ventilation or a P/F ratio <250
•c.) Platelets <100 x109/L, or a drop of 50 x109/L in the 3 days prior to enrollment
•d.) Arterial pH < 7.30 or base deficit > 5 mmol/L in association with a lactate >/= to 4.0 mmol/L
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•We will exclude patients who have any one of the following criteria at the time of enrolment:
•1.Other forms of shock including cardiogenic, hemorrhagic, hypovolemic, neurogenic, or obstructive shock.
•2.Received vasopressor therapy for greater than 18 hours prior to enrolment
•3.Bleeding Risk:
•a.Clinical: Active bleeding; head trauma; intracranial surgery or stroke within 3 months; history of intracerebral arteriovenous malformation, cerebral aneurysm or mass lesions of the central nervous system; history of a bleeding diatheses; gastrointestinal bleeding within 6 weeks; presence of an epidural or spinal catheter; selected cases of recent surgery where IV therapeutic UFH is considered contraindicated
•b.Laboratory: Platelet count <30 x109/L, INR >2.0, or baseline aPTT >50 sec prior to enrollment
•4. Known or suspected adverse reaction to UFH including heparin induced thrombocytopenia (HIT).
•5.Use of any of the following treatments: UFH to treat a thrombotic event within 12 hours before enrolment; LMWH at a higher dose than recommended for prophylactic use within 12 hours before the infusion; warfarin (used within 7 days before study entry AND if the INR exceeds 2.0 at enrolment); thrombolytic therapy within 3 previous days
•6.Terminal illness with a life expectancy of less than 3 months, or no commitment to aggressive care
•7.Consent declined from patient or substitute decision-maker
•8. Physician refusal

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