Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02135770
• Collaborator: (none)
• Enrollment: 115
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Sepsis With Septic Shock; Severe Sepsis Without Septic Shock	Drug: Unfractionated heparin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Control Trial to Assessed the Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Severe Sepsis
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Unfractionated Heparin Low dose unfractionated Heparin 10 unit/kgBW/hour continuous infusion	Drug: Unfractionated heparin; 10 unit/kgBW/hour continuous infusion for 72 hours
Placebo Comparator: Placebo Normal saline packed in same form with trial drugs.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. clinical outcome [14 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Cipto Mangunkusumo General Hospital	Jakarta		Indonesia	10430

Sponsors and Collaborators

• Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Khie Chen Lie, MD, Indonesia University
• ClinicalTrials.gov Identifier: NCT02135770
• Other Study ID Numbers: HLDS01
• First Posted: May 12, 2014
• Last Update Posted: Jul 8, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Khie Chen Lie, MD, Indonesia University: heparin; sepsis; inflammation
• Additional relevant MeSH terms: Sepsis; Toxemia; Shock, Septic; Inflammation; Shock; Heparin; Calcium heparin

Study Results

No Results Posted as of Jul 8, 2014