Randomized Control Trial to Assessed the Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Severe Sepsis
Overview
- Phase
- Phase 3
- Intervention
- Unfractionated heparin
- Conditions
- Severe Sepsis With Septic Shock
- Sponsor
- Indonesia University
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- inflammation
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Sepsis is a clinical syndrome which infection trigger systemic inflammatory response. Uncontrolled inflammatory process leads to multiple organ dysfunction and cause early mortality in severe sepsis. Unfractionated heparin is an anticoagulant that widely used either for DVT prophylaxis or treatment of disseminated intravascular coagulation. Heparin also have an anti-inflammatory effect through downregulates nuclear factor kappa B and tumor necrosis factor alpha.
Aim of this study is to determine effects of low dose unfractionated heparin treatment on inflammation in severe sepsis patient.
Investigators
Khie Chen Lie
MD
Indonesia University
Eligibility Criteria
Inclusion Criteria
- •Patients with severe sepsis and septic shock define by revised Sepsis Criteria (2001)
- •Within 48 hour diagnose sepsis
- •Agree to participate
Exclusion Criteria
- •Pregnancy and lactation
- •Severe thrombocytopenia, platelet less than 30.000/mm3
- •Bleeding or high risk of major bleeding
- •During anticoagulant treatment
- •After thrombolytic treatment
- •Decompensated chronic liver diseases
- •Chronic kidney diseases on dialysis treatment
- •During high dose corticosteroid treatment
- •HIV with CD4 count below 50/mm3
- •Indication for high dose heparin treatment
Arms & Interventions
Unfractionated Heparin
Low dose unfractionated Heparin 10 unit/kgBW/hour continuous infusion
Intervention: Unfractionated heparin
Outcomes
Primary Outcomes
inflammation
Time Frame: 3 days
determine effects of low dose unfractionated heparin treatment on nuclear factor kappa B, inhibitor kappa B kinase and tumor necrosis factor-alpha.
Secondary Outcomes
- clinical outcome(14 days)