Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis
|ClinicalTrials.gov Identifier: NCT02135770|
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : July 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Sepsis With Septic Shock Severe Sepsis Without Septic Shock||Drug: Unfractionated heparin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Control Trial to Assessed the Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Severe Sepsis|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135770
|Dr. Cipto Mangunkusumo General Hospital|
|Jakarta, Indonesia, 10430|