Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

University of Indonesia (UI)

Status and phase: Completed; Phase 3

Conditions: Severe Sepsis Without Septic Shock; Severe Sepsis With Septic Shock

Treatments: Drug: Unfractionated heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT02135770

HLDS01

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

115 participants in 2 patient groups, including a placebo group

Unfractionated Heparin

Experimental group

Description:

Low dose unfractionated Heparin 10 unit/kgBW/hour continuous infusion

Treatment:

Drug: Unfractionated heparin

Placebo

Placebo Comparator group

Description:

Normal saline packed in same form with trial drugs.