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Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02135770
First Posted: May 12, 2014
Last Update Posted: July 8, 2014
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.
Information provided by (Responsible Party):
Khie Chen Lie, Indonesia University
  Purpose

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 Intervention Phase
Severe Sepsis With Septic Shock Severe Sepsis Without Septic Shock Drug: Unfractionated heparin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Khie Chen Lie, Indonesia University:

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


Enrollment: 115
Study Start Date: January 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02135770


Locations
Indonesia
Dr. Cipto Mangunkusumo General Hospital
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
  More Information

Responsible Party: Khie Chen Lie, MD, Indonesia University
ClinicalTrials.gov Identifier: NCT02135770     History of Changes
Other Study ID Numbers: HLDS01
First Submitted: May 8, 2014
First Posted: May 12, 2014
Last Update Posted: July 8, 2014
Last Verified: July 2014

Keywords provided by Khie Chen Lie, Indonesia University:
heparin
sepsis
inflammation

Additional relevant MeSH terms:
Inflammation
Sepsis
Toxemia
Shock
Shock, Septic
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action