Assessment of Pleotropic Effect of Heparin Infusion Versus Subcutaneous Injection in Septic Shock Patients

• Status: Recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep venous thrombosis (DVT), is a common and severe complication of critical illness. Critically ill patients are at high risk of VTE because they combine both general risk factors together with specific ICU risk factors of VTE.Vasopressor administration was found to be an independent risk factor for DVT. certainly explained by reduced absorption of subcutaneous heparin linked to the vasoconstriction of peripheral blood vessels. Critically ill patients, due to altered pharmacokinetics behavior of unfractionated heparin, continuous intravenous infusion of the low doses of unfractionated heparin has been proposed. Standard prophylaxis with subcutaneous (SC) heparin is less efficient in patients requiring vasopressors .Sepsis is a systemic inflammatory response due to an infection. Both inflammatory mediators and coagulation are involved in sepsis. the release of the inflammatory mediators such as interleukins and tumor necrosis factor cause damage of the endothelium and activation of coagulation which promotes inflammatory process .Unfractionated heparin is the most negatively charged biological molecule known, heparin has a strong ability to interfere with the functioning of positively charged molecules. Due to the difference in charges, heparin has been documented to interact with over 100 proteins.57 Interleukins, cytokines, and receptors located on endothelial cells, which are involved in the acute phase response, are positively charged, and thus are a reasonable target for the modulating effects of heparin. Heparin has strong anti-inflammatory effects with many possible mechanisms, including binding to cell-surface glycosaminoglycan's, preventing leukocyte migration, direct binding to chemokines and cytokines, and inhibition of intracellular NF-kB .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Damanhour University
• Treatments: Anti-Inflammatory Agents; Calcium heparin; Heparin

Criteria

Inclusion Criteria:

• Adults Patients aged 18 years old or greater diagnosed with septic shock. The diagnosis of sepsis was made according to "surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock" by Sepsis-3 task force defines sepsis as the presence of suspected infection along with rise in total SOFA score ≥2 from baseline.

Exclusion Criteria:

• Need for corticosteroids

• vasopressors likely to be discontinued in the next 6 hours

• Received vasopressor therapy for greater than 18 hours prior to enrolment.

• Pregnancy

• High risk for bleeding

• Requirement of therapeutic anticoagulant

• PLT < 50_106 per mL

• History of HIT

• Allergy to heparin