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.
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 19, 2023
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedJune 4, 2024
June 1, 2024
9 months
January 19, 2023
June 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Ratio between native and truncated procalcitonin during different conditions of hyperprocalcitoninemia
Measurement performed by using ELISA-assay.
Blood withdrawal takes approximately 5 minutes per patient
Secondary Outcomes (3)
DPP-4-activity
Blood withdrawal takes approximately 5 minutes per patient
Proinflammatory cytokines
Blood withdrawal takes approximately 5 minutes per patient
Immun cell surface-antigens
Blood withdrawal takes approximately 5 minutes per patient
Study Arms (6)
Sepsis
Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.
SIRS
Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.
Adiposity
Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.
Granulomatosis with polyangiitis / microscopic polyangiitis
Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.
Pre-eclampsia
Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.
Healthy controls
Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.
Interventions
Observational study measuring procalcitonin-variants in different patient collectives by obtaining 3 blood collection tubes per patient.
Eligibility Criteria
Patients from the University Hospital Münster who suffer from different diseases which are accompanied by hyperprocalcitoninemia.
You may qualify if:
- 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
You may not qualify if:
- participation in an interventional study trial within the last 3 months
- relationship to study investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Münster
Münster, North Rhine-Westphalia, 48147, Germany
Related Publications (4)
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.
PMID: 10648832BACKGROUNDBrabenec 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.
PMID: 35699655BACKGROUNDWeglohner 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.
PMID: 11786196RESULTKintrup 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.
PMID: 39636188DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 19, 2023
First Posted
January 30, 2023
Study Start
February 1, 2022
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
June 4, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share