Status:
TERMINATED
Heparin Anticoagulation in Septic Shock
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
CancerCare Manitoba
Conditions:
Septic Shock
Vasodilatory Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is a pragmatic open-label international randomized trial comparing therapeutic dose intravenous unfractionated heparin (UFH) to standard care venous thromboprophylaxis in patients diagnosed...
Detailed Description
Background and significance: Sepsis and septic shock account for 10% of admissions to the intensive care unit and constitute the second most frequent cause of death among admitted patients. The mortal...
Eligibility Criteria
Inclusion
- ≥ 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:
- 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.
- Need for invasive mechanical ventilation or a P/F ratio \<250
- Platelets \<100 x109/L, or a drop of 50 x109/L in the 3 days prior to enrolment
- Arterial pH \< 7.30 or base deficit \> 5 mmol/L in association with a lactate \> 4.0 mmol/L
Exclusion
- 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:
- 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
- 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
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT03378466
Start Date
March 12 2018
End Date
December 31 2021
Last Update
May 24 2022
Active Locations (51)
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1
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
2
Hospital Sao Jose
Altamira, Brazil
3
Hospital Novo Atibaia
Atibaia, Brazil
4
Hospital de Amor (Barretos)
Barretos, Brazil