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NCT Number: NCT05703802

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

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.

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Key information

Conditions

Sepsis Adiposity Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Body Weight Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Female Urogenital Diseases and Pregnancy Complications Granulomatosis With Polyangiitis Hypertension, Pregnancy-Induced Immune System Diseases Infections Inflammation Lung Diseases Lung Diseases, Interstitial Microscopic Polyangiitis Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Procalcitonin Respiratory Tract Diseases SIRS Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Inflammatory Response Syndrome Systemic Vasculitis Urogenital Diseases Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Münster

Münster, North Rhine-Westphalia, 48147, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Procalcitonin-variants ELISA-Assay

Diagnostic Test

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

Primary outcomes

  1. Ratio between native and truncated procalcitonin during different conditions of hyperprocalcitoninemia

    Time frame: Blood withdrawal takes approximately 5 minutes per patient

    Measurement performed by using ELISA-assay.

Secondary outcomes

  1. DPP-4-activity

    Time frame: Blood withdrawal takes approximately 5 minutes per patient

    Measurement performed by using a commercial DPP4-ELISA-kit.

  2. Proinflammatory cytokines

    Time frame: Blood withdrawal takes approximately 5 minutes per patient

    Measurement performed by using a commercial multiplex immunoassay kit.

  3. Immun cell surface-antigens

    Time frame: Blood withdrawal takes approximately 5 minutes per patient

    Measurement performed by using fluorescence-acivated cell sorting (FACS).

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 30, 2023
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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