Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02135770

Enrollment

115

Registered

2014-05-12

Start date

2013-01-31

Completion date

2014-06-30

Last updated

2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Sepsis Without Septic Shock, Severe Sepsis With Septic Shock

Keywords

heparin, sepsis, inflammation

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.

Interventions

DRUGUnfractionated heparin

10 unit/kgBW/hour continuous infusion for 72 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
inflammation	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

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

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026