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

NCT ID: NCT05703802

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-11-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Sepsis

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

Procalcitonin-variants ELISA-Assay

Intervention Type DIAGNOSTIC_TEST

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

SIRS

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

Procalcitonin-variants ELISA-Assay

Intervention Type DIAGNOSTIC_TEST

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

Adiposity

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

Procalcitonin-variants ELISA-Assay

Intervention Type DIAGNOSTIC_TEST

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

Granulomatosis with polyangiitis / microscopic polyangiitis

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

Procalcitonin-variants ELISA-Assay

Intervention Type DIAGNOSTIC_TEST

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

Pre-eclampsia

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

Procalcitonin-variants ELISA-Assay

Intervention Type DIAGNOSTIC_TEST

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

Healthy controls

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

Procalcitonin-variants ELISA-Assay

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Procalcitonin-variants ELISA-Assay

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Sebastian Kintrup

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Münster

Münster, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Wrenger S, Kahne T, Bohuon C, Weglohner W, Ansorge S, Reinhold D. Amino-terminal truncation of procalcitonin, a marker for systemic bacterial infections, by dipeptidyl peptidase IV (DP IV). FEBS Lett. 2000 Jan 21;466(1):155-9. doi: 10.1016/s0014-5793(99)01779-2.

Reference Type BACKGROUND
PMID: 10648832 (View on PubMed)

Brabenec L, Muller M, Hellenthal KEM, Karsten OS, Pryvalov H, Otto M, Holthenrich A, Matos ALL, Weiss R, Kintrup S, Hessler M, Dell'Aquila A, Thomas K, Nass J, Margraf A, Nottebaum AF, Rossaint J, Zarbock A, Vestweber D, Gerke V, Wagner NM. Targeting Procalcitonin Protects Vascular Barrier Integrity. Am J Respir Crit Care Med. 2022 Aug 15;206(4):488-500. doi: 10.1164/rccm.202201-0054OC.

Reference Type BACKGROUND
PMID: 35699655 (View on PubMed)

Weglohner W, Struck J, Fischer-Schulz C, Morgenthaler NG, Otto A, Bohuon C, Bergmann A. Isolation and characterization of serum procalcitonin from patients with sepsis. Peptides. 2001 Dec;22(12):2099-103. doi: 10.1016/s0196-9781(01)00541-1.

Reference Type RESULT
PMID: 11786196 (View on PubMed)

Kintrup S, Brabenec L, Zurek-Leffers FM, Hellenthal KEM, Cyran L, Meybohm P, Gerke V, Wagner NM. Detection and Evaluation of Procalcitonin Variants As Diagnostic Tools in Systemic Inflammation. Anesth Analg. 2025 May 1;140(5):1073-1082. doi: 10.1213/ANE.0000000000007170.

Reference Type DERIVED
PMID: 39636188 (View on PubMed)

Other Identifiers

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10-AnIt-19

Identifier Type: -

Identifier Source: org_study_id

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