An observational study in Sepsis, sponsored by Abionic SA. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Abionic SA · Observational
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Among 517 studies in Sepsis with a site in United States — 75 open to participants now, 99 under way, 3 of them phase 3. Sepsis · United States.
Among the 517 studies in Sepsis with a site in United States, this one is the 60th largest by enrollment of the 204 observational ones that give a count, is one of 26 that started in 2019, is one of 204 observational ones, and was the 337th registered.
2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.
Browse Sepsis studies →75 of the 517 studies in Sepsis with a site in United States are open now. Recruiting first, the newest first:
Deepull Diagnostics S.L. · Sites in United States, France, Germany and 2 more countries
Intermountain Health Care, Inc. · Sites in United States
Ages 18+
Bassett Healthcare · Sites in United States
Ages 18+
Duke University · Sites in United States
Ages 0 days–7 days
Vanderbilt University Medical Center · Sites in United States
Ages 1 days–12 mo
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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517 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 50 · Phase 2 80 · Phase 3 47 · Phase 4 25
First in 1988; this study’s year is marked. 26 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 544 is above the median of 150 across 1,162 observational studies indexed under Sepsis.
Median enrollment 84 across the 310 interventional studies, 183 across the 204 observational. Of the 361 that completed or were terminated, 117 (32%) have results posted.
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135 of 517 have an industry lead sponsor. The 10 most frequent:
Abionic SA is the lead sponsor of 8 studies on the registry; none are open to participants now.
Abionic SA has 5 studies filed under Sepsis — fewer than ten, so there is no comparison to draw.
36 of the studies in Sepsis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06817408Mayo ClinicDynamics of Organ Damage and Immune Exhaustion During Sepsis | 2026-12 |
| NCT04796285Brigham and Women's HospitalA Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor | 2026-12 |
| NCT01315782The University of Texas Health Science Center, HoustonAlveolar Dead Space as Predictor of Organ Failure in Severe Sepsis | 2026-12 |
| NCT06692400Loma Linda UniversityThe Effects of Endotracheal Suctioning on Pain and Serum Markers | 2026-12 |
| NCT03133208University of FloridaSepsis Associated Encephalopathy (SAE) Biomarkers | 2026-12-15 |
Add all 36 to your calendar (.ics) → With an account.
Among the 517 studies in Sepsis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a multicenter, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on ICU patients at risk of sepsis as an aid in identifying sepsis.
ICU admitted patients at risk of developing sepsis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Blood sampling
Daily blood sample which will be taken for the PSP measurement using the abioSCOPE as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein \[CRP\] and Procalcitonin \[PCT\]).
Ability of the abioSCOPE PSP assay performed on day 1 of a participant's ICU admission to correctly identify those with sepsis.
Assess the clinical sensitivity and specificity of the abioSCOPE PSP assay obtained on day 1 of ICU stay to identify sepsis within 3 days, based on EIRC assessment of sepsis.
Time frame: Day 1
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2019 to primary completion in Aug 2023, 44 months.
Of 52 industry-sponsored observational studies under Sepsis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 44. This study's 44 months is above that.
Counting every sponsor, half of 544 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Abionic SA