SepsisHERONCT02366650
Help in the Emergency Room to Detect Organ Dysfunction
An observational study of Sepsis and Critical Illness, run by Region Skane at 4 sites in 3 countries.
Trial summary
The purpose of this prospective, non-interventional clinical study is to assess the clinical validity of a number of markers (including Heparin Binding Protein (HBP), Procalcitonin (PCT), C-reactive protein (CRP), White cell count (WCC) and lactate) for indicating the presence of organ dysfunction, or outcome, of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Critical Illness
- How many people
- 600 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Feb 2015to Aug 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject enrolment will be based on adult patients presenting to the emergency department at the different sites with suspicion of organ dysfunction or identified at the hospital wars/units.
Who may be able to join
- ≥18 years of age ii) 1 or more of the following criteria: Saturation<90% without oxygen or <93% with oxygen or reported saturation<90%, Respiratory frequency >25/min, Altered mental awareness, Heart rate >120/min, Systolic blood pressure <100 mm Hg. iv) informed consent.
Who cannot join
- None
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Sweden2 sites, 2 recruiting
- Recruiting
Helsingborg
Helsingborg
Jonas Tverring, jonas@tverring.com
- Recruiting
Lund ED
Lund
Adam Linder, adam.linder@med.lu.se
About this study
Official title: Help in the Emergency Room to Detect Organ Dysfunction - The HERO Study
The purpose of this prospective, non-interventional clinical study is to assess the clinical validity of a number of markers (including Heparin Binding Protein (HBP), Procalcitonin (PCT), C-reactive protein (CRP), White cell count (WCC) and lactate) for indicating the presence of organ dysfunction, or outcome, of patients with organ dysfunctions following emergency department admission or hospitalization. Secondary objectives are to identify novel putative biomarkers and to identify risk factors for negative long-term effects of acute critical illness The HBP assay is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Heparin Binding Protein in human plasma.
- Conditions
- Sepsis, Critical Illness
- Medical subject headings
- Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lund ED | appr 100-200 patients at Lund ED | |
| Helsingborg ED | appr 100-200 patients at Helsingborg ED | |
| Vancouver ED | appr 100 patients at St Paul's hospital ED | |
| Bern ED | appr 100 patients at Bern ED |
What is being measured
The primary outcome is the main question the study is designed to answer.
infection-induced organ dysfunction
To evaluate the presence or development of infection-induced organ dysfunction within a 72 hour time period from enrolment at the Emergency Department.
Measured: 72 hours
Secondary outcomes (7)
To compare the specificity, sensitivity and accuracy of HBP against other biochemical markers
Measured: 72 hours
To investigate the specificity, sensitivity and accuracy in biochemical markers to predict mortality, ICU-care, days in hospital and the persistence of organ dysfunction.
Measured: 90 days
To investigate and identify risk factors for a negative long-term (5-10 year) outcome.
Measured: 10 years
• Organ dysfunction 24-36 and 72 hours after arriving at the hospital
Measured: 72 hrs
• Primary diagnosis infection (y/n)
Measured: 72 hrs
• number of days on ward and ICU
Measured: 90 days
• number of days of antibiotics , time to effective antibiotics
Measured: 72 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Linder, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366650
- Sponsor's protocol ID
- HERO1
- Acronym
- HERO
- Status last verified
- Oct 2015
- First submitted
- 12 Feb 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Help in the Emergency Room to Detect Organ Dysfunction - The HERO Study
- ClinicalTrials.gov ID
- NCT02366650
- Acronym / sponsor ID
- HERO / HERO1
- Conditions
- Sepsis, Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 19 Feb 2015 (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.
The purpose of this prospective, non-interventional clinical study is to assess the clinical validity of a number of markers (including Heparin Binding Protein (HBP), Procalcitonin (PCT), C-reactive protein (CRP), White cell count (WCC) and lactate) for indicating the presence of organ dysfunction, or outcome, of patients with organ dysfunctions following emergency department admission or hospitalization. Secondary objectives are to identify novel putative biomarkers and to identify risk factors for negative long-term effects of acute critical illness The HBP assay is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Heparin Binding Protein in human plasma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lund ED | – | –appr 100-200 patients at Lund ED |
| Helsingborg ED | – | –appr 100-200 patients at Helsingborg ED |
| Vancouver ED | – | –appr 100 patients at St Paul's hospital ED |
| Bern ED | – | –appr 100 patients at Bern ED |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject enrolment will be based on adult patients presenting to the emergency department at the different sites with suspicion of organ dysfunction or identified at the hospital wars/units.
Key inclusion criteria (1 listed)
- ≥18 years of age ii) 1 or more of the following criteria: Saturation<90% without oxygen or <93% with oxygen or reported saturation<90%, Respiratory frequency >25/min, Altered mental awareness, Heart rate >120/min, Systolic blood pressure <100 mm Hg. iv) informed consent.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
infection-induced organ dysfunction
Time frame: 72 hours
To evaluate the presence or development of infection-induced organ dysfunction within a 72 hour time period from enrolment at the Emergency Department.
7 secondary outcomes
To compare the specificity, sensitivity and accuracy of HBP against other biochemical markers
Time frame: 72 hours
To investigate the specificity, sensitivity and accuracy in biochemical markers to predict mortality, ICU-care, days in hospital and the persistence of organ dysfunction.
Time frame: 90 days
To investigate and identify risk factors for a negative long-term (5-10 year) outcome.
Time frame: 10 years
• Organ dysfunction 24-36 and 72 hours after arriving at the hospital
Time frame: 72 hrs
• Primary diagnosis infection (y/n)
Time frame: 72 hrs
• number of days on ward and ICU
Time frame: 90 days
• number of days of antibiotics , time to effective antibiotics
Time frame: 72 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Critical Illness, run by Region Skane at 4 sites in 3 countries.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, Canada, Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection-induced organ dysfunction (time frame: 72 hours). 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 21 Oct 2015.