Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

Severe Sepsis With Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135770
• Other study ID #: HLDS01
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2014
• Last updated: July 6, 2014
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Sepsis
• Severe Sepsis With Septic Shock
• Severe Sepsis Without Septic Shock
• Shock
• Shock, Septic
• Toxemia

Intervention

Drug:
• Unfractionated heparin
10 unit/kgBW/hour continuous infusion for 72 hours

Locations

Country	Name	City	State
Indonesia	Dr. Cipto Mangunkusumo General Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammation	determine effects of low dose unfractionated heparin treatment on nuclear factor kappa B, inhibitor kappa B kinase and tumor necrosis factor-alpha.	3 days	No
Secondary	clinical outcome	determine impact of low dose unfractionated heparin on mortality and improvement APACHE II score	14 days	Yes