Severe Sepsis With Septic ShockPhase 3NCT02135770
Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis
A Phase 3 study testing Unfractionated heparin in people with Severe Sepsis With Septic Shock and Severe Sepsis Without Septic Shock, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Severe Sepsis With Septic Shock, Severe Sepsis Without Septic Shock
- What is being tested?
- Unfractionated heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteIndonesia
- Study dates
- Jan 2013to Jun 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with severe sepsis and septic shock define by revised Sepsis Criteria (2001)
- Within 48 hour diagnose sepsis
- Agree to participate
Who cannot join
- 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
Show all 10Show fewer
- Chronic kidney diseases on dialysis treatment
- During high dose corticosteroid treatment
- HIV with CD4 count below 50/mm3
- Indication for high dose heparin treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial to Assessed the Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Severe 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.
- Being tested
- Unfractionated heparin
- Keywords
- heparin, sepsis, inflammation
- Medical subject headings
- Sepsis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfractionated heparinDrug
10 unit/kgBW/hour continuous infusion for 72 hours
| Study group | Role | What they receive |
|---|---|---|
| Unfractionated Heparin | Experimental | Low dose unfractionated Heparin 10 unit/kgBW/hour continuous infusion Receives: Drug: Unfractionated heparin |
| Placebo | Placebo comparator | Normal saline packed in same form with trial drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammation
determine effects of low dose unfractionated heparin treatment on nuclear factor kappa B, inhibitor kappa B kinase and tumor necrosis factor-alpha.
Measured: 3 days
Secondary outcomes (1)
clinical outcome
determine impact of low dose unfractionated heparin on mortality and improvement APACHE II score
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Sepsis With Septic ShockStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khie Chen Lie, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135770
- Sponsor's protocol ID
- HLDS01
- Status last verified
- Jul 2014
- First submitted
- 8 May 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial to Assessed the Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Severe Sepsis
- ClinicalTrials.gov ID
- NCT02135770
- Acronym / sponsor ID
- HLDS01
- Keywords
- heparin, sepsis, inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unfractionated Heparin | Experimental | Drug: Unfractionated heparinLow dose unfractionated Heparin 10 unit/kgBW/hour continuous infusion |
| Placebo | Placebo comparator | –Normal saline packed in same form with trial drugs. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with severe sepsis and septic shock define by revised Sepsis Criteria (2001)
- Within 48 hour diagnose sepsis
- Agree to participate
Key exclusion criteria (10 listed)
- Pregnancy and lactation
- Severe thrombocytopenia, platelet less than 30.000/mm3
- Bleeding or high risk of major bleeding
- During anticoagulant treatment
- After thrombolytic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unfractionated heparin10 unit/kgBW/hour continuous infusion for 72 hours | Drug | Unfractionated Heparin |
Primary outcome
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.
1 secondary outcome
clinical outcome
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
Related trials for Severe Sepsis With Septic Shock
Recruiting
Plasma Exchange in Children With Severe Sepsis and Septic Shock
Severe Sepsis
Not yet recruitingObservational study
Wearable Sweat Sensor for High-Concentration Lactate Monitoring in Critically Ill Patients
Sepsis, Severe Sepsis With Septic Shock
Not yet recruiting
Effects of Esmolol on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock
Septic Shock, Sepsis
Active, not recruitingObservational study
Monocyte Distribution Width (MDW) in the General Population of Emergency Department Patients With and Without Bacteremia
Bacteremia, Bacteremia Sepsis
RecruitingObservational study
Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis
Sepsis, Severe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Unfractionated heparin in people with Severe Sepsis With Septic Shock and Severe Sepsis Without Septic Shock, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammation (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.