Safety of Heparin in Patients With Septic Shock
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 5/5/2014 |
| Start Date: | December 2010 |
| End Date: | October 2013 |
| Contact: | Elizabeth Luzier, RN |
| Email: | elizabeth.luzier@ucdenver.edu |
| Phone: | 303-724-3597 |
Safety of Heparin Anticoagulation for Prevention of Death in Patients With Septic Shock.
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.
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.
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 -
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