Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Severe Sepsis With Septic Shock Severe Sepsis Without Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Unfractionated Heparin

Low dose unfractionated Heparin 10 unit/kgBW/hour continuous infusion

Group Type EXPERIMENTAL

Unfractionated heparin

Intervention Type DRUG

10 unit/kgBW/hour continuous infusion for 72 hours

Placebo

Normal saline packed in same form with trial drugs.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Unfractionated heparin

10 unit/kgBW/hour continuous infusion for 72 hours

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No