Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

NCT02135770 | Completed Phase 3

• 1 other identifier: HLDS01
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Sepsis With Septic Shock; Severe Sepsis Without Septic Shock

Keywords

heparin; sepsis; inflammation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• clinical outcome

  14 days

Study Arms (2)

Unfractionated Heparin

EXPERIMENTAL

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

Drug: Unfractionated heparin

Placebo

PLACEBO COMPARATOR

Normal saline packed in same form with trial drugs.

Interventions

Unfractionated heparin DRUG

10 unit/kgBW/hour continuous infusion for 72 hours

Unfractionated Heparin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with severe sepsis and septic shock define by revised Sepsis Criteria (2001)
• Within 48 hour diagnose sepsis
• Agree to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Dr. Cipto Mangunkusumo General Hospital

Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Sepsis; Inflammation

Interventions

Heparin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 12, 2014
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

ID (1)