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Establishment of an ELISA for the Recognition of Procalcitonin Variants in Patients With Hyperprocalcitonemia.

Establishment of an Enzyme-linked Immunosorbent Assay for the Recognition of Procalcitonin Variants and Characterization of Procalcitonin Variants in Patients With Hyperprocalcitonemia.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05703802
Enrollment
30
Registered
2023-01-30
Start date
2022-02-01
Completion date
2022-11-01
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adiposity, Granulomatosis With Polyangiitis, Microscopic Polyangiitis, Pre-Eclampsia, Procalcitonin, Sepsis, SIRS

Brief summary

Procalcitonin is a protein consisting of 116 amino-acids which can rapidly rise under inflammatory conditions and sepsis. More than 20 years ago it has been shown that dipeptidylpeptidase-4 (DPP-4) cleaves procalcitonin from the n-terminus, resulting in a truncated procalcitonin-variant which consists of 114 aminoacids. Within their workgroup the investigators found that the truncated procalcitonin-variant had deleterious effects on vascular integrity during sepsis in mice. However, it is unknown if this applies also in humans. By using an ELISA-assay the investigators want to examine the ratio between native and truncated human procalcitonin during diseases accompanied with hyperprocalcitoninemia and correlate the results with clinical data.

Detailed description

Procalcitonin is a protein consisting of 116 amino-acids which can rapidly rise under inflammatory conditions and sepsis. More than 20 years ago it has been shown that dipeptidylpeptidase-4 (DPP-4) cleaves procalcitonin from the n-terminus, resulting in a truncated procalcitonin-variant which consists of 114 aminoacids. Within their workgroup the investigators found that the truncated procalcitonin-variant had deleterious effects on vascular integrity during sepsis in mice: They observed that binding of truncated procalcitonin to the CRLR/RAMP1-receptor on vascular endothelium lead to phosphorylation and destruction of VE-cadherin, an essential part of adherens junctions. Consequently, paracellular leakage of proteins and fluid from blood vessels developed. It is unknown if these effects also apply to humans. By using an ELISA-assay the investigators want to examine the ratio between native and truncated human procalcitonin during diseases accompanied with hyperprocalcitoninemia and correlate the results with clinical data. Futhermore, they want to examine if the procalcitonin-variants have influence on cytokine levels and surface antigens on immune cells by performing multiplex immunoassays and FACS-analysis.

Interventions

DIAGNOSTIC_TESTProcalcitonin-variants ELISA-Assay

Observational study measuring procalcitonin-variants in different patient collectives by obtaining 3 blood collection tubes per patient.

Sponsors

University Hospital Muenster
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Age \>18 * Patients with diagnosis... * Sepsis or, * SIRS after cardiothoracic surgery or, * adipositas or, * granulomatosis with polyangiitis/microscopic polyangiitis or, * pre-eclampsia * healthy control subjects * written informed consent

Exclusion criteria

* participation in an interventional study trial within the last 3 months * relationship to study investigator

Design outcomes

Primary

MeasureTime frameDescription
Ratio between native and truncated procalcitonin during different conditions of hyperprocalcitoninemiaBlood withdrawal takes approximately 5 minutes per patientMeasurement performed by using ELISA-assay.

Secondary

MeasureTime frameDescription
DPP-4-activityBlood withdrawal takes approximately 5 minutes per patientMeasurement performed by using a commercial DPP4-ELISA-kit.
Proinflammatory cytokinesBlood withdrawal takes approximately 5 minutes per patientMeasurement performed by using a commercial multiplex immunoassay kit.
Immun cell surface-antigensBlood withdrawal takes approximately 5 minutes per patientMeasurement performed by using fluorescence-acivated cell sorting (FACS).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026