Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

Phase 3

Completed

• Conditions: Severe Sepsis Without Septic Shock; Severe Sepsis With Septic Shock
• Interventions: Drug: Unfractionated heparin

• Registration Number: NCT02135770
• Lead Sponsor: Indonesia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-06
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unfractionated Heparin	Unfractionated heparin	Low dose unfractionated Heparin 10 unit/kgBW/hour continuous infusion

Primary Outcome Measures

Name	Time	Method
inflammation	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 Outcome Measures

Name	Time	Method
clinical outcome	14 days	determine impact of low dose unfractionated heparin on mortality and improvement APACHE II score

Trial Locations

Locations (1)

Dr. Cipto Mangunkusumo General Hospital; 🇮🇩 Jakarta, Indonesia