Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT03378466
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age
* 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 (≥ 1 litre if dialysis dependent end-stage renal disease or if the patient is felt to be in congestive heart failure).
* At least 1 other new organ dysfunction (in addition to refractory hypotension), defined by the following:
1. 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.
2. Need for invasive mechanical ventilation or a P/F ratio \<250
3. Platelets \<100 x109/L, or a drop of 50 x109/L in the 3 days prior to enrolment
4. Arterial pH \< 7.30 or base deficit \> 5 mmol/L in association with a lactate \> 4.0 mmol/L
Exclusion Criteria:
* Other forms of shock including cardiogenic, hemorrhagic, hypovolemic, neurogenic, or obstructive shock.
* Clinical suspicion or confirmation of a viral hemorrhagic shock syndrome including, but not limited to, dengue fever
* Rapid clinical improvement; vasopressors likely to be discontinued in the next 6 hours
* Received vasopressor therapy for greater than 18 hours prior to enrolment
* Bleeding Risk:
1. 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
2. Laboratory: Platelet count \<50 x109/L, INR \>2.0, or baseline aPTT \>50 seconds prior to enrolment
* Known or suspected adverse reaction to UFH including heparin induced thrombocytopenia (HIT).
* 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 (if used within 7 days before study entry AND if the INR exceeds 2.0 at enrolment); thrombolytic therapy within 3 previous days; use of IIb/IIIa inhibitors within the previous 7 days.
* Need for therapeutic anticoagulation
* Terminal illness with a life expectancy of less than 3 months, or no commitment to aggressive care.
* Consent declined from patient or authorized 3rd party
* Physician refusal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03378466
Study Brief:
Protocol Section:
NCT03378466