Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis
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.
|Severe Sepsis With Septic Shock Severe Sepsis Without Septic Shock||Drug: Unfractionated heparin||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Control Trial to Assessed the Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Severe Sepsis|
- 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.
- clinical outcome [ Time Frame: 14 days ]determine impact of low dose unfractionated heparin on mortality and improvement APACHE II score
|Study Start Date:||January 2013|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Unfractionated Heparin
Low dose unfractionated Heparin 10 unit/kgBW/hour continuous infusion
Drug: Unfractionated heparin
10 unit/kgBW/hour continuous infusion for 72 hours
Placebo Comparator: Placebo
Normal saline packed in same form with trial drugs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02135770
|Dr. Cipto Mangunkusumo General Hospital|
|Jakarta, Indonesia, 10430|