Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

Indonesia University115 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

115

Conditions

Severe Sepsis With Septic Shock Severe Sepsis Without Septic Shock

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

inflammation

determine effects of low dose unfractionated heparin treatment on nuclear factor kappa B, inhibitor kappa B kinase and tumor necrosis factor-alpha.

Time frame: 3 days

Secondary Outcomes

clinical outcome

determine impact of low dose unfractionated heparin on mortality and improvement APACHE II score

Time frame: 14 days