Sepsis SyndromePRESSNCT02562261
Platelet REactivity in Sepsis Syndrome (PRESS)
An observational study of Sepsis Syndrome, run by Charalambos .A. Gogos at 1 site in Greece.
Trial summary
Activation of blood platelets is a typical finding in patients with systemic inflammation and sepsis.They seem to mediate key pro-inflammatory mediator secretion, immune-cell activation while their adhesion to the endothelium enhances the pro-coagulatory activity of endothelial cells impairing microcirculation thus… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2015to Jun 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Within 0-8 hours of presentation in emergency department patients will be assessed and assigned upon their health status in four distinct groups of uncomplicated infection/bacteraemia , sepsis, severe sepsis/septic shock as this is defined by International Sepsis Definitions Conference. Thirty five healthy volunteers will serve as a control group.
Who may be able to join
- Patients presenting 0-8 hours post admission with signs of one of the following i) uncomplicated infection/bacteremia ii) sepsis iii) severe sepsis iv) septic shock
- 30 healthy subjects
- Signed informed consent
Who cannot join
- Pregnancy
- Breastfeeding
- Inability to give informed consent
- PLTs<70.000/ul or PLTs>741.000 ul
- Ht<25% or Ht>52%
- History of P2Y12 or GPIIb/IIIainhibitors the last 15 days prior assortment
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- Patients with inherited (vonWillebrand factor deficiency, Glanzmann thrombasthenia, Bernard-Sulier syndrome) or established acquired platelet disorders (HIT)
- Patients undergoing hemodialysis
- History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months.
- Previous history of immunologic disease (neoplasm, autoimmune disorders, HIV)
- Subjects receiving daily treatment with immune-modulating regimens.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet Reactivity During Different Stages of Sepsis
Activation of blood platelets is a typical finding in patients with systemic inflammation and sepsis.They seem to mediate key pro-inflammatory mediator secretion, immune-cell activation while their adhesion to the endothelium enhances the pro-coagulatory activity of endothelial cells impairing microcirculation thus, may lead to multiple organ dysfunction. However, the exact effects of bacterial products on platelet function have not been found to be consistent and may vary according to the species, the timing of the study, and the pathogenesis of sepsis. Data vary, including both increased and decreased platelet reactivity and aggregation among patients with sepsis compared to healthy controls. Defining platelet's behaviour during sepsis is particularly important in view of recent findings revealing potential association between antiplatelet therapy and reduction in short term mortality, incidence of acute lung injury and intensive care unit admission in critically ill patients.This study aims to measure P2Y12 mediated platelet reactivity, -using the point-of-care P2Y12 VerifyNow assay, in platelet reactivity units (PRU)- along different stages of sepsis, including bacteremia/uncomplicated infection, sepsis, severe sepsis and septic shock. Subgroup follow up of patients going along different stages will also be performed. At the end of this study analysis of clinical and laboratory findings in correlation with platelet reactivity will be performed to assess platelet aggregation during sepsis.
- Conditions
- Sepsis Syndrome
- Keywords
- sepsis, platelet, platelet reactivity, P2Y12
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Sepsis
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 |
|---|---|---|
| Healthy | Not described | |
| Uncomplicated Infection | Showing signs of infection as defined by International Sepsis Definitions Conference 2003 | |
| Sepsis | Sepsis is defined as systemic inflammatory response syndrome (i.e. presence of two or more of the following 1. Temperature of <36 °C (96.8 °F) or >38 °C (100.4 °F) 2. Heart rate >90bpm 3. Respiratory rate >20/min or PaCO2<32 mmHg (4.3 kPa) 4. WBC <4x109/L (<4000/mm³), >12x109/L (>12,000/mm³), or 10% bands in response to an infectious process.. | |
| Severe Sepsis/Septic Shock | Severe sepsis is defined as sepsis with sepsis-induced organ dysfunction or tissue hypoperfusion [manifesting as hypotension, elevated lactate (serum lactate 2 times the upper limit of normal), or decreased urine output (urine output < 0.5 ml/kg/hr)] Septic shock is defined as severe sepsis plus persistently low blood pressure (< 5th percentile for age or systolic blood pressure < 2 standard deviations below normal for age) following the administration of intravenous fluids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
P2Y12 mediated Platelet Reactivity on presentation
Measurement of P2Y12 mediated platelet reactivity of patients in different study groups i.e healthy controls, uncomplicated infection, sepsis, severe sepsis/septic shock in P2Y12 reactivity units (PRU). PRU measurement will take place on time of presentation and recognition of signs of infection
Measured: 0 hours post presentation
Comparison of P2Y12 mediated Platelet Reactivity between study groups
Measurements of P2Y12 mediated platelet reactivity of different study groups that have taken place on presentation will be compared following completion of study recruitment
Measured: at 1 year
Secondary outcomes (3)
Serum levels of pro-inflammatory mediators in various study groups
Patient serum will be collected and cytokines will be measured in all patients
Measured: 1 month to 1 year
Correlation between serum levels of pro-inflammatory mediators and measured PRU between various study groups
Following measurement of serum cytokines (outcome 3), assessment of potential correlation with PRU will be performed
Measured: 1 month to 1 year
Repeated measurement of PRU in the same subject when transiting from one group to another
Patients transiting from one stage of sepsis to another (for example severe sepsis to healthy state OR from uncomplicated infection to sepsis) will be repetitively measured to assess platelet reactivity alteration
Measured: 1 hour to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis SyndromeStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charalambos .A. Gogos
- Sponsor type
- University, hospital or other
- Collaborators
- Hellenic Society for Chemotherapy : Hellenic Sepsis Study Group, University Hospital of Patras
- Responsible party
- Sponsor-investigator, Charalambos .A. Gogos, University Hospital of Patras
- Investigators
- Charalampos Gogos, MD,PhD, Study director, University Hospital of PatrasKarolina Akinosoglou, MD,PhD, Principal investigator, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562261
- Sponsor's protocol ID
- 24958/19-12-13
- Acronym
- PRESS
- Status last verified
- Oct 2018
- First submitted
- 15 Sep 2015
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Reactivity During Different Stages of Sepsis
- ClinicalTrials.gov ID
- NCT02562261
- Acronym / sponsor ID
- PRESS / 24958/19-12-13
- Conditions
- Sepsis Syndrome
- Keywords
- sepsis, platelet, platelet reactivity, P2Y12
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Charalambos .A. GogosUniversity, hospital or other
- Collaborators
- Hellenic Society for Chemotherapy : Hellenic Sepsis Study Group, University Hospital of Patras
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Sep 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.
Activation of blood platelets is a typical finding in patients with systemic inflammation and sepsis.They seem to mediate key pro-inflammatory mediator secretion, immune-cell activation while their adhesion to the endothelium enhances the pro-coagulatory activity of endothelial cells impairing microcirculation thus, may lead to multiple organ dysfunction. However, the exact effects of bacterial products on platelet function have not been found to be consistent and may vary according to the species, the timing of the study, and the pathogenesis of sepsis. Data vary, including both increased and decreased platelet reactivity and aggregation among patients with sepsis compared to healthy controls. Defining platelet's behaviour during sepsis is particularly important in view of recent findings revealing potential association between antiplatelet therapy and reduction in short term mortality, incidence of acute lung injury and intensive care unit admission in critically ill patients.This study aims to measure P2Y12 mediated platelet reactivity, -using the point-of-care P2Y12 VerifyNow assay, in platelet reactivity units (PRU)- along different stages of sepsis, including bacteremia/uncomplicated infection, sepsis, severe sepsis and septic shock. Subgroup follow up of patients going along different stages will also be performed. At the end of this study analysis of clinical and laboratory findings in correlation with platelet reactivity will be performed to assess platelet aggregation during sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | – |
| Uncomplicated Infection | – | –Showing signs of infection as defined by International Sepsis Definitions Conference 2003 |
| Sepsis | – | –Sepsis is defined as systemic inflammatory response syndrome (i.e. presence of two or more of the following 1. Temperature of <36 °C (96.8 °F) or >38 °C (100.4 °F) 2. Heart rate >90bpm 3. Respiratory rate >20/min or PaCO2<32 mmHg (4.3 kPa) 4. WBC <4x109/L (<4000/mm³), >12x109/L (>12,000/mm³), or 10% bands in response to an infectious process.. |
| Severe Sepsis/Septic Shock | – | –Severe sepsis is defined as sepsis with sepsis-induced organ dysfunction or tissue hypoperfusion [manifesting as hypotension, elevated lactate (serum lactate 2 times the upper limit of normal), or decreased urine output (urine output < 0.5 ml/kg/hr)] Septic shock is defined as severe sepsis plus persistently low blood pressure (< 5th percentile for age or systolic blood pressure < 2 standard deviations below normal for age) following the administration of intravenous fluids. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Within 0-8 hours of presentation in emergency department patients will be assessed and assigned upon their health status in four distinct groups of uncomplicated infection/bacteraemia , sepsis, severe sepsis/septic shock as this is defined by International Sepsis Definitions Conference. Thirty five healthy volunteers will serve as a control group.
Key inclusion criteria (3 listed)
- Patients presenting 0-8 hours post admission with signs of one of the following i) uncomplicated infection/bacteremia ii) sepsis iii) severe sepsis iv) septic shock
- 30 healthy subjects
- Signed informed consent
Key exclusion criteria (11 listed)
- Pregnancy
- Breastfeeding
- Inability to give informed consent
- PLTs<70.000/ul or PLTs>741.000 ul
- Ht<25% or Ht>52%
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
P2Y12 mediated Platelet Reactivity on presentation
Time frame: 0 hours post presentation
Measurement of P2Y12 mediated platelet reactivity of patients in different study groups i.e healthy controls, uncomplicated infection, sepsis, severe sepsis/septic shock in P2Y12 reactivity units (PRU). PRU measurement will take place on time of presentation and recognition of signs of infection
Comparison of P2Y12 mediated Platelet Reactivity between study groups
Time frame: at 1 year
Measurements of P2Y12 mediated platelet reactivity of different study groups that have taken place on presentation will be compared following completion of study recruitment
3 secondary outcomes
Serum levels of pro-inflammatory mediators in various study groups
Time frame: 1 month to 1 year
Correlation between serum levels of pro-inflammatory mediators and measured PRU between various study groups
Time frame: 1 month to 1 year
Repeated measurement of PRU in the same subject when transiting from one group to another
Time frame: 1 hour to 1 month
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 23 Oct 2018.
- Platelet reactivity in sepsis syndrome: results from the PRESS studyLink provided by the sponsor.
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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.
Charalampos Gogos, MD,PhD study director
University Hospital of Patras
Karolina Akinosoglou, MD,PhD principal investigator
University Hospital of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Syndrome, run by Charalambos .A. Gogos at 1 site in Greece.
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 11 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 23 Oct 2018. 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 Greece. 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?
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?
P2Y12 mediated Platelet Reactivity on presentation (time frame: 0 hours post presentation). The study lists 2 primary outcomes in all. 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 23 Oct 2018.