SepsisNCT05703802
Establishment of an ELISA for the Recognition of Procalcitonin Variants in Patients With Hyperprocalcitonemia.
An observational study of Sepsis and Pre-Eclampsia, run by University Hospital Muenster at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Pre-Eclampsia, Granulomatosis With Polyangiitis
- What is being tested?
- Procalcitonin-variants ELISA-Assay
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2022to 1 Nov 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients from the University Hospital Münster who suffer from different diseases which are accompanied by hyperprocalcitoninemia.
Who may be able to join
- Age >18
- Patients with diagnosis...
- Sepsis or,
- SIRS after cardiothoracic surgery or,
- adipositas or,
- granulomatosis with polyangiitis/microscopic polyangiitis or,
Show all 9Show fewer
- pre-eclampsia
- healthy control subjects
- written informed consent
Who cannot join
- participation in an interventional study trial within the last 3 months
- relationship to study investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Münster
Münster, North Rhine-Westphalia, 48147
About this study
Official title: Establishment of an Enzyme-linked Immunosorbent Assay for the Recognition of Procalcitonin Variants and Characterization 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.
Read the detailed 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.
- Conditions
- Sepsis, Pre-Eclampsia, Granulomatosis With Polyangiitis, Microscopic Polyangiitis, Adiposity, SIRS
- Being tested
- Procalcitonin-variants ELISA-Assay
- Medical subject headings
- Sepsis, Pre-Eclampsia, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin-variants ELISA-AssayDiagnostic test
Observational study measuring procalcitonin-variants in different patient collectives by obtaining 3 blood collection tubes per patient.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia. Receives: Diagnostic Test: Procalcitonin-variants ELISA-Assay | |
| SIRS | Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia. Receives: Diagnostic Test: Procalcitonin-variants ELISA-Assay | |
| Adiposity | Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia. Receives: Diagnostic Test: Procalcitonin-variants ELISA-Assay | |
| Granulomatosis with polyangiitis / microscopic polyangiitis | Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia. Receives: Diagnostic Test: Procalcitonin-variants ELISA-Assay | |
| Pre-eclampsia | Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia. Receives: Diagnostic Test: Procalcitonin-variants ELISA-Assay | |
| Healthy controls | Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia. Receives: Diagnostic Test: Procalcitonin-variants ELISA-Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio between native and truncated procalcitonin during different conditions of hyperprocalcitoninemia
Measurement performed by using ELISA-assay.
Measured: Blood withdrawal takes approximately 5 minutes per patient
Secondary outcomes (3)
DPP-4-activity
Measurement performed by using a commercial DPP4-ELISA-kit.
Measured: Blood withdrawal takes approximately 5 minutes per patient
Proinflammatory cytokines
Measurement performed by using a commercial multiplex immunoassay kit.
Measured: Blood withdrawal takes approximately 5 minutes per patient
Immun cell surface-antigens
Measurement performed by using fluorescence-acivated cell sorting (FACS).
Measured: Blood withdrawal takes approximately 5 minutes per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Feb 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Kintrup, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703802
- Sponsor's protocol ID
- 10-AnIt-19
- Status last verified
- Jun 2024
- First submitted
- 19 Jan 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10648832Brabenec 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.
PubMed 35699655Weglohner 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.
PubMed 11786196Kintrup 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.
PubMed 39636188
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of an Enzyme-linked Immunosorbent Assay for the Recognition of Procalcitonin Variants and Characterization of Procalcitonin Variants in Patients With Hyperprocalcitonemia.
- ClinicalTrials.gov ID
- NCT05703802
- Acronym / sponsor ID
- 10-AnIt-19
- Conditions
- Sepsis, Pre-Eclampsia, Granulomatosis With Polyangiitis, Microscopic Polyangiitis, Adiposity, SIRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Diagnostic Test: Procalcitonin-variants ELISA-AssayWithdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia. |
| SIRS | – | Diagnostic Test: Procalcitonin-variants ELISA-AssayWithdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia. |
| Adiposity | – | Diagnostic Test: Procalcitonin-variants ELISA-AssayWithdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia. |
| Granulomatosis with polyangiitis / microscopic polyangiitis | – | Diagnostic Test: Procalcitonin-variants ELISA-AssayWithdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia. |
| Pre-eclampsia | – | Diagnostic Test: Procalcitonin-variants ELISA-AssayWithdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia. |
| Healthy controls | – | Diagnostic Test: Procalcitonin-variants ELISA-AssayWithdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients from the University Hospital Münster who suffer from different diseases which are accompanied by hyperprocalcitoninemia.
Key inclusion criteria (9 listed)
- Age >18
- Patients with diagnosis...
- Sepsis or,
- SIRS after cardiothoracic surgery or,
- adipositas or,
Key exclusion criteria (2 listed)
- participation in an interventional study trial within the last 3 months
- relationship to study investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procalcitonin-variants ELISA-AssayObservational study measuring procalcitonin-variants in different patient collectives by obtaining 3 blood collection tubes per patient. | Diagnostic test | Adiposity, Granulomatosis with polyangiitis / microscopic polyangiitis, Healthy controls, Pre-eclampsia, SIRS, Sepsis |
Primary outcome
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.
3 secondary outcomes
DPP-4-activity
Time frame: Blood withdrawal takes approximately 5 minutes per patient
Proinflammatory cytokines
Time frame: Blood withdrawal takes approximately 5 minutes per patient
Immun cell surface-antigens
Time frame: Blood withdrawal takes approximately 5 minutes per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 10648832Wrenger 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.
- Background: PubMed 35699655Brabenec 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.
- Results publication: PubMed 11786196Weglohner 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.
- Derived from this study: PubMed 39636188Kintrup 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Pre-Eclampsia, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio between native and truncated procalcitonin during different conditions of hyperprocalcitoninemia (time frame: Blood withdrawal takes approximately 5 minutes per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05703802, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.