Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

July 6, 2014 updated by: Khie Chen Lie, Indonesia University

Randomized Control Trial to Assessed the Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Severe Sepsis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 10430
        • Dr. Cipto Mangunkusumo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical outcome
Time Frame: 14 days
determine impact of low dose unfractionated heparin on mortality and improvement APACHE II score
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 12, 2014

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 6, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLDS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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