Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Khie Chen Lie, Indonesia University
ClinicalTrials.gov Identifier:
NCT02135770
First received: May 8, 2014
Last updated: July 6, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Indonesia University:

Primary Outcome Measures:
  • inflammation [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02135770

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

No publications provided

Responsible Party: Khie Chen Lie, MD, Indonesia University
ClinicalTrials.gov Identifier: NCT02135770     History of Changes
Other Study ID Numbers: HLDS01
Study First Received: May 8, 2014
Last Updated: July 6, 2014
Health Authority: Indonesia: Ethics Committee

Keywords provided by 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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014