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Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02135770
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : July 8, 2014
Information provided by (Responsible Party):
Khie Chen Lie, 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.

Condition or disease Intervention/treatment Phase
Severe Sepsis With Septic Shock Severe Sepsis Without Septic Shock Drug: Unfractionated heparin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : January 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. clinical outcome [ Time Frame: 14 days ]
    determine impact of low dose unfractionated heparin on mortality and improvement APACHE II score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02135770

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Dr. Cipto Mangunkusumo General Hospital
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
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Responsible Party: Khie Chen Lie, MD, Indonesia University Identifier: NCT02135770    
Other Study ID Numbers: HLDS01
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Keywords provided by Khie Chen Lie, Indonesia University:
Additional relevant MeSH terms:
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Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action