Sepsis
Conditions
Keywords
sepsis, septic shock, anticoagulation, intensive care unit
Brief summary
Sepsis is a syndrome comprised of a systemic inflammatory response, signs of tissue hypoperfusion, and organ in the setting of presumed infection. Heparin, in addition to being an anticoagulant, is also a well-known antiinflammatory. The investigators believe that unfractionated heparin has the potential to save the lives of septic patients at a drastically reduced cost. This is a dose escalation study to determine the safety of increasing levels of heparin in this patient population; compare markers of anticoagulation and inflammation between treatment groups; and compare clinical outcomes between groups.
Interventions
DRUGheparin
intravenous heparin titrated to an aPTT of 40-50 seconds starting between 300-500 units per hour and adjusted every 6 hours based on aPTT, starting within 24 hours of ICU admission up to 6 days.
Sponsors
University of Colorado, Denver
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-90 in the medical or surgical intensive care unit 2. Within 24 hours of diagnosis with sepsis as defined by the Bone criteria (see Appendix A); 3. Acute Physiology and Chronic Health Evaluation (APACHE II) score of \> 25; 4. Signed consent
Exclusion criteria
1. Currently therapeutically anticoagulated for known thrombotic diagnosis (myocardial infarction, venous thromboembolism) known molecular hypercoagulable state (Factor V Leiden, lupus anticoagulant, antiphospholipid antibody syndrome); or use of cardiopulmonary support machines (left-ventricular assist device, intra-aortic balloon pump, veno-venous ultrafiltration, or extracorporeal membrane oxygenation. 2. History of gastrointestinal or cerebral hemorrhage within past 3 months; 3. Active bleeding; 4. Known allergy or sensitivity to heparin; 5. History of heparin-induced thrombocytopenia 6. Organ transplantation recipient -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major bleeding | This outcome will be measured for an average of 30 days | Defined as:decrease in hemoglobin greater than 2g/dl and/or transfusion of 2 or more units of packed red blood cells. However, if there are obvious other reasons for bleeding, such as within 12 hours of major surgery, coagulopathy unrelated to heparin or an anatomical basis. |
Countries
United States
Outcome results
None listed