Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in 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.

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Key information

Conditions

Severe Sepsis With Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Severe Sepsis Without Septic Shock Systemic Inflammatory Response Syndrome

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Cipto Mangunkusumo General Hospital

Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unfractionated heparin

Drug

10 unit/kgBW/hour continuous infusion for 72 hours

Primary outcomes

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 outcomes

clinical outcome

Time frame: 14 days

determine impact of low dose unfractionated heparin on mortality and improvement APACHE II score

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: May 12, 2014
Registry last updated: Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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