An observational study in Sepsis, Pre-Eclampsia and Granulomatosis With Polyangiitis, sponsored by University Hospital Muenster. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by University Hospital Muenster · Observational
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.
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's enrollment of 30 is below the median of 150 across 1,162 observational studies indexed under Sepsis.
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Patients from the University Hospital Münster who suffer from different diseases which are accompanied by hyperprocalcitoninemia.
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.
Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.
Diagnostic Test: Procalcitonin-variants ELISA-Assay
Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.
Diagnostic Test: Procalcitonin-variants ELISA-Assay
Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.
Diagnostic Test: Procalcitonin-variants ELISA-Assay
Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.
Diagnostic Test: Procalcitonin-variants ELISA-Assay
Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.
Diagnostic Test: Procalcitonin-variants ELISA-Assay
Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.
Diagnostic Test: Procalcitonin-variants ELISA-Assay
Observational study measuring procalcitonin-variants in different patient collectives by obtaining 3 blood collection tubes per patient.
Ratio between native and truncated procalcitonin during different conditions of hyperprocalcitoninemia
Measurement performed by using ELISA-assay.
Time frame: Blood withdrawal takes approximately 5 minutes per patient
DPP-4-activity
Measurement performed by using a commercial DPP4-ELISA-kit.
Time frame: Blood withdrawal takes approximately 5 minutes per patient
Proinflammatory cytokines
Measurement performed by using a commercial multiplex immunoassay kit.
Time frame: Blood withdrawal takes approximately 5 minutes per patient
Immun cell surface-antigens
Measurement performed by using fluorescence-acivated cell sorting (FACS).
Time frame: Blood withdrawal takes approximately 5 minutes per patient
Plan to share: No
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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