Comparison of Sensitivity Between Presepsine and Lactate for the Diagnosis of Severe Sepsis. (NCT02300415) | Clinical Trial Compass
WithdrawnNot Applicable
Comparison of Sensitivity Between Presepsine and Lactate for the Diagnosis of Severe Sepsis.
Stopped: L'étude a été abandonnée
0Started 2014-12
Plain-language summary
Severe sepsis and sepsis shock are common in emergency department, with a high mortality rate. The potential severity of this disease impose a diagnosis as early as possible to start antibiotic therapy and hemodynamic support. Conventional biomarkers are an important support for the emergency physician. However, comparison of sensitivity and specificity for new biomarkers, like presepsine, suggests that they can be more efficient in this area.
In this single-center, prospective, non-interventional study, we propose to compare the sensitivity of presepsine to that of lactate for the diagnosis of severe sepsis and septic shock We emit to main hypothesis that the sensitivity of presepsine is higher than that of lactate for the diagnosis of severe sepsis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age\> 18 years
* Presence of at least two SIRS criteria (T °\> 38.3 ° or \<36 °, tachycardia\> 90 / min, tachypnea\> 20 / min, recent alteration of consciousness)
* Suspected Infection
* Indication of an arterial lactate assay on medical advice
* Affiliation to social security
* Informed Consent
Exclusion Criteria:
* Renal dialysis
* Scalable neoplasia chemotherapy
* Patient Palliative Care
* Private Patient freedom or under legal protection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was withdrawn before enrolling anyone — does that mean the research question about presepsine and lactate for diagnosing severe sepsis was answered somewhere else, or is it still an open area my care team should know about?
2Since this study was specifically comparing presepsine and lactate as diagnostic markers for severe sepsis and septic shock, which of these tests is my care team currently using to monitor my condition, and why?
3Because this trial never ran, there's no data from it on how well presepsine performs compared to lactate — are there other completed studies you'd recommend I look at to understand how these markers are being used in diagnosis today?
4Given that this was a diagnostic study rather than a treatment trial, how does knowing about markers like presepsine and lactate actually change the treatment decisions my team would make for me?
5Are there any currently active or completed trials looking at better ways to diagnose or monitor severe sepsis that you think would be worth discussing as part of my care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.