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Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

Primary Purpose

Severe Sepsis With Septic Shock, Severe Sepsis Without Septic Shock

Status

Completed

Phase

Phase 3

Locations

Indonesia

Study Type

Interventional

Intervention

Unfractionated heparin

About this trial

This is an interventional treatment trial for Severe Sepsis With Septic Shock focused on measuring heparin, sepsis, inflammation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Dr. Cipto Mangunkusumo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Unfractionated Heparin

Placebo

Arm Description

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

Normal saline packed in same form with trial drugs.

Outcomes

Primary Outcome Measures

inflammation

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

clinical outcome

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

Full Information

NCT ID

NCT02135770

First Posted

May 8, 2014

Last Updated

July 6, 2014

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT02135770

Brief Title

Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Sepsis With Septic Shock, Severe Sepsis Without Septic Shock

Keywords

heparin, sepsis, inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Unfractionated Heparin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Normal saline packed in same form with trial drugs.

Intervention Type

Drug

Intervention Name(s)

Unfractionated heparin

Intervention Description

10 unit/kgBW/hour continuous infusion for 72 hours

Primary Outcome Measure Information:

Title

inflammation

Description

determine effects of low dose unfractionated heparin treatment on nuclear factor kappa B, inhibitor kappa B kinase and tumor necrosis factor-alpha.

Time Frame

3 days

Secondary Outcome Measure Information:

Title

clinical outcome

Description

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

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Dr. Cipto Mangunkusumo General Hospital

City

Jakarta

ZIP/Postal Code

10430

Country

Indonesia

12. IPD Sharing Statement

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Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

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