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

University Hospital Muenster

Status: Completed

Conditions: Pre-Eclampsia; Granulomatosis With Polyangiitis; Procalcitonin; SIRS; Adiposity; Microscopic Polyangiitis; Sepsis

Treatments: Diagnostic Test: Procalcitonin-variants ELISA-Assay

Study type: Observational

Funder types: Other

Identifiers

NCT05703802

10-AnIt-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 6 patient groups

Sepsis

Description:

Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.

Treatment:

Diagnostic Test: Procalcitonin-variants ELISA-Assay

SIRS

Description:

Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.

Treatment:

Diagnostic Test: Procalcitonin-variants ELISA-Assay

Adiposity

Description:

Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.

Treatment:

Diagnostic Test: Procalcitonin-variants ELISA-Assay

Granulomatosis with polyangiitis / microscopic polyangiitis

Description:

Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.

Treatment:

Diagnostic Test: Procalcitonin-variants ELISA-Assay

Pre-eclampsia

Description:

Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.

Treatment:

Diagnostic Test: Procalcitonin-variants ELISA-Assay

Healthy controls

Description:

Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.

Treatment:

Diagnostic Test: Procalcitonin-variants ELISA-Assay