SepsisNCT05060679
Presepsin:Gelsolin Ratio in Sepsis-related Organ Dysfunction
An observational study of Sepsis and Acute Kidney Injury Due to Sepsis, run by University of Pecs at 1 site in Hungary.
Trial summary
In the present study, 126 patients were enrolled (23 control, 38 non-septic and 65 septic patients). Blood samples were collected from septic patients at the intensive care unit (ICU) at three time points (T1-3): T1: within 12h after admission; T2: second day morning; T3: third day morning. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis, Acute Kidney Injury Due to Sepsis, Septic Shock
- What is being tested?
- Supportive therapy at the ICU, Sepsis therapy and Sepsis-related organ dysfunction therapy
- How many people
- 126 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2018to 29 Feb 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy control individuals (n=23), non-septic ICU patients (n=38) and septic patients (n=65) were enrolled, while the septic group was also investigated based on the occurrence of sepsis-related organ dysfunction (e.g. acute kidney injury, hemodynamic instability, acute respiratory distress syndrome)
Who may be able to join
- Non-septic patients needing ICU supportive treatment after major surgical interventions
- Sepsis
- Sepsis-related organ dysfunction (e.g. acute kidney injury, hemodynamic instability, acute respiratory distress syndrome)
Who cannot join
- under 18 years of age
- unobtainable consent
- end-stage renal disease
- kidney transplantation
- malignancies needing palliative care
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs
Pécs, Baranya, 7624
About this study
Official title: Presepsin:Gelsolin Ratio, as a Promising Marker of Sepsis-related Organ Dysfunction: a Pilot Study
In the present study, 126 patients were enrolled (23 control, 38 non-septic and 65 septic patients). Blood samples were collected from septic patients at the intensive care unit (ICU) at three time points (T1-3): T1: within 12h after admission; T2: second day morning; T3: third day morning. Sampling points for non-septic ICU patients were T1 and T3. Exclusion criteria were patients under 18 years of age, unobtainable consent, end-stage renal disease requiring chronic dialysis or kidney transplantation and patients with malignancies needing palliative care. Not more than one sample (venous blood) was collected from control patients. Plasma presepsin levels were determined by an automated chemiluminescence-based Point of Care instrument while serum gelsolin levels were measured using an automated immune turbidimetric assay. Plasma presepsin concentrations were expressed as pg/mL, while serum gelsolin levels were expressed as mg/L. Data were compared with laboratory and clinical parameters. Patients were categorized by the Sepsis-3 definitions and 10-day mortality data were investigated. Presepsin:gelsolin ratio was evaluated in major sepsis-related organ dysfunctions including hemodynamic disturbances, respiratory insufficiency and acute kidney injury (AKI).
Read the detailed description
Presepsin is the 13-kDa soluble N-terminal fragment of the 55-kDa cluster of differentiation (CD) marker protein CD14, which is the receptor for lipopolysaccharide (LPS) and LPS-binding protein complexes. CD14 is a glycoprotein expressed mostly on the membrane surface of macrophages, monocytes and granulocytes which is released and degraded during inflammation after the recognition of pathogen-associated molecular patterns (PAMP), thus probably resulting in earlier elevation of plasma presepsin (PSEP) levels than the conventional sepsis biomarkers (C-reactive protein, procalcitonin). There is a growing body of evidence indicating increasing PSEP levels as kidney function decreases (e.g. during chronic kidney disease or sepsis-related AKI). Gelsolin (GSN) is a multifunctional protein existing in three different isoforms. Secreted or plasma GSN (MW = 83 kDa) is an essential component of the so-called extracellular actin scavenger system, therefore, decreasing serum GSN levels were reported in various clinical conditions (e.g. severe sepsis, multiple organ dysfunction syndrome (MODS), extensive trauma, acute liver failure, myocardial infarction). As albumin levels also tend to decrease in severe catabolic conditions, the simultaneous measurement of PSEP and GSN could prove to be useful regarding the diagnosis and prognosis of sepsis and sepsis-related organ dysfunction. Therefore, a new potential marker was investigated: the presepsin:gelsolin (PSEP:GSN) ratio. The main focuses of this study were analyzing the time course of PSEP:GSN ratio in non-septic and septic patients, while also investigating its diagnostic and prognostic utility in various sepsis-related organ dysfunctions in contrast to the conventional sepsis markers and clinical prognostic scores.
- Conditions
- Sepsis, Acute Kidney Injury Due to Sepsis, Septic Shock, Acute Respiratory Distress Syndrome
- Being tested
- Supportive therapy at the ICU, Sepsis therapy, Sepsis-related organ dysfunction therapy
- Keywords
- Sepsis-3, Organ dysfunction, Prognosis, Presepsin, Gelsolin, Presepsin:gelsolin ratio, Novel biomarker
- Medical subject headings
- Sepsis, Shock, Septic, Respiratory Distress Syndrome, Meretoja syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive therapy at the ICUOther
Non-septic ICU patients received adequate supportive treatment (fluid resuscitation, respiratory, anticoagulation, antimicrobial and vasopressor therapy along with sedation, ulcer prophylaxis and nutrition. Blood sampling for non-septic patients were the first (T1) and third (T3) postoperative morning at the ICU. Besides, 23 healthy outpatients were documented without sepsis or sepsis-related organ dysfuntion as a control group.
Sepsis therapyOther
Patients receiving sepsis therapy followed the international guidelines of the 2016 Surviving Sepsis Campaign (SSC) regarding respiratory, antimicrobial, anticoagulation, vasopressor and hydrocortisone therapy, along with adequate fluid resuscitation, sedation, ulcer prophylaxis and nutrition. Blood samples were collected at the ICU from this patient group at three time points (T1-3): T1: within 12 hours after admission; T2: second day morning; T3: third day morning of follow-up.
Sepsis-related organ dysfunction therapyOther
Patient management of sepsis and sepsis-related organ dysfunction followed the international guidelines of the 2016 Surviving Sepsis Campaign (SSC) regarding respiratory, antimicrobial, anticoagulation, vasopressor and hydrocortisone therapy, along with adequate fluid resuscitation, sedation, ulcer prophylaxis, nutrition and renal replacement therapy (if needed). In this patient group, blood sampling was performed at three time points (T1-3): T1: within 12 hours after admission; T2: second day morning; T3: third day morning of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Non-sepsis | Non-septic patients receive supportive treatment at the ICU. Receives: Other: Supportive therapy at the ICU | |
| Sepsis | Patients receive sepsis therapy. Receives: Other: Sepsis therapy | |
| Sepsis-related organ dysfunction | Patients receive sepsis therapy and advanced supportive treatment based on the occurrence of specific sepsis-related organ dysfunctions. Receives: Other: Sepsis-related organ dysfunction therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Presepsin concentrations
Plasma samples were centrifuged (10 min, 1500 g), then sample aliquots were stored without preservatives at -70 °C until analysis. Plasma presepsin levels were measured using an automated Point of Care instrument (PATHFAST; LSI Medience Corporation, Tokyo, Japan) based on a chemiluminescent enzyme immunoassay.
Measured: 3 days
Serum gelsolin concentrations
Clotted blood samples were centrifuged (10 min, 1500 g), then sample aliquots were stored without preservatives at -70 °C until analysis. Serum gelsolin levels were determined with an automated immune turbidimetric assay (Cobas 8000/c502 module (Roche Diagnostics GmbH, Mannheim, Germany)).
Measured: 3 days
Secondary outcomes (1)
Presepsin:gelsolin ratios
Plasma presepsin levels were determined by an automated Point of Care instrument, while serum gelsolin concentrations were measured using an immune turbidimetric assay, therefore Presepsin:gelsolin ratios could be calculated.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Jan 2018
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dániel Ragán, MD, University of Pecs
- Investigators
- Dániel Ragán, MD, Principal investigator, Department of Laboratory Medicine, Medical School, University of PécsPéter Kustán, MD, PhD, Principal investigator, Department of Laboratory Medicine, Medical School, University of PécsZoltán Horváth-Szalai, MD, PhD, Principal investigator, Department of Laboratory Medicine, Medical School, University of PécsBalázs Szirmay, MD, Principal investigator, Department of Laboratory Medicine, Medical School, University of PécsAttila Miseta, MD, Dsc, Principal investigator, Department of Laboratory Medicine, Medical School, University of PécsGábor Woth, MD, PhD, Principal investigator, Department of Anesthesiology and Intensive Therapy, Medical School, University of PécsTamás Kőszegi, MD, PhD, Principal investigator, Department of Laboratory Medicine, Medical School, University of PécsDiána Mühl, MD, PhD, Principal investigator, Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060679
- Sponsor's protocol ID
- 4327.316-2900/KK15/2011
- Status last verified
- Mar 2022
- First submitted
- 18 Sep 2021
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ragan D, Kustan P, Horvath-Szalai Z, Szirmay B, Miseta A, Woth G, Koszegi T, Muhl D. Presepsin: gelsolin ratio, as a promising marker of sepsis-related organ dysfunction: a prospective observational study. Front Med (Lausanne). 2023 May 5;10:1126982. doi: 10.3389/fmed.2023.1126982. eCollection 2023.
PubMed 37215727
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presepsin:Gelsolin Ratio, as a Promising Marker of Sepsis-related Organ Dysfunction: a Pilot Study
- ClinicalTrials.gov ID
- NCT05060679
- Acronym / sponsor ID
- 4327.316-2900/KK15/2011
- Conditions
- Sepsis, Acute Kidney Injury Due to Sepsis, Septic Shock, Acute Respiratory Distress Syndrome
- Keywords
- Sepsis-3, Organ dysfunction, Prognosis, Presepsin, Gelsolin, Presepsin:gelsolin ratio, Novel biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 29 Sep 2021 (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.
In the present study, 126 patients were enrolled (23 control, 38 non-septic and 65 septic patients). Blood samples were collected from septic patients at the intensive care unit (ICU) at three time points (T1-3): T1: within 12h after admission; T2: second day morning; T3: third day morning. Sampling points for non-septic ICU patients were T1 and T3. Exclusion criteria were patients under 18 years of age, unobtainable consent, end-stage renal disease requiring chronic dialysis or kidney transplantation and patients with malignancies needing palliative care. Not more than one sample (venous blood) was collected from control patients. Plasma presepsin levels were determined by an automated chemiluminescence-based Point of Care instrument while serum gelsolin levels were measured using an automated immune turbidimetric assay. Plasma presepsin concentrations were expressed as pg/mL, while serum gelsolin levels were expressed as mg/L. Data were compared with laboratory and clinical parameters. Patients were categorized by the Sepsis-3 definitions and 10-day mortality data were investigated. Presepsin:gelsolin ratio was evaluated in major sepsis-related organ dysfunctions including hemodynamic disturbances, respiratory insufficiency and acute kidney injury (AKI).
Detailed description
Presepsin is the 13-kDa soluble N-terminal fragment of the 55-kDa cluster of differentiation (CD) marker protein CD14, which is the receptor for lipopolysaccharide (LPS) and LPS-binding protein complexes. CD14 is a glycoprotein expressed mostly on the membrane surface of macrophages, monocytes and granulocytes which is released and degraded during inflammation after the recognition of pathogen-associated molecular patterns (PAMP), thus probably resulting in earlier elevation of plasma presepsin (PSEP) levels than the conventional sepsis biomarkers (C-reactive protein, procalcitonin). There is a growing body of evidence indicating increasing PSEP levels as kidney function decreases (e.g. during chronic kidney disease or sepsis-related AKI). Gelsolin (GSN) is a multifunctional protein existing in three different isoforms. Secreted or plasma GSN (MW = 83 kDa) is an essential component of the so-called extracellular actin scavenger system, therefore, decreasing serum GSN levels were reported in various clinical conditions (e.g. severe sepsis, multiple organ dysfunction syndrome (MODS), extensive trauma, acute liver failure, myocardial infarction). As albumin levels also tend to decrease in severe catabolic conditions, the simultaneous measurement of PSEP and GSN could prove to be useful regarding the diagnosis and prognosis of sepsis and sepsis-related organ dysfunction. Therefore, a new potential marker was investigated: the presepsin:gelsolin (PSEP:GSN) ratio. The main focuses of this study were analyzing the time course of PSEP:GSN ratio in non-septic and septic patients, while also investigating its diagnostic and prognostic utility in various sepsis-related organ dysfunctions in contrast to the conventional sepsis markers and clinical prognostic scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-sepsis | – | Other: Supportive therapy at the ICUNon-septic patients receive supportive treatment at the ICU. |
| Sepsis | – | Other: Sepsis therapyPatients receive sepsis therapy. |
| Sepsis-related organ dysfunction | – | Other: Sepsis-related organ dysfunction therapyPatients receive sepsis therapy and advanced supportive treatment based on the occurrence of specific sepsis-related organ dysfunctions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy control individuals (n=23), non-septic ICU patients (n=38) and septic patients (n=65) were enrolled, while the septic group was also investigated based on the occurrence of sepsis-related organ dysfunction (e.g. acute kidney injury, hemodynamic instability, acute respiratory distress syndrome)
Key inclusion criteria (3 listed)
- Non-septic patients needing ICU supportive treatment after major surgical interventions
- Sepsis
- Sepsis-related organ dysfunction (e.g. acute kidney injury, hemodynamic instability, acute respiratory distress syndrome)
Key exclusion criteria (5 listed)
- under 18 years of age
- unobtainable consent
- end-stage renal disease
- kidney transplantation
- malignancies needing palliative care
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 |
|---|---|---|
| Supportive therapy at the ICUNon-septic ICU patients received adequate supportive treatment (fluid resuscitation, respiratory, anticoagulation, antimicrobial and vasopressor therapy along with sedation, ulcer prophylaxis and nutrition. Blood sampling for non-septic patients were the first (T1) and third (T3) postoperative morning at the ICU. Besides, 23 healthy outpatients were documented without sepsis or sepsis-related organ dysfuntion as a control group. | Other | Non-sepsis |
| Sepsis therapyPatients receiving sepsis therapy followed the international guidelines of the 2016 Surviving Sepsis Campaign (SSC) regarding respiratory, antimicrobial, anticoagulation, vasopressor and hydrocortisone therapy, along with adequate fluid resuscitation, sedation, ulcer prophylaxis and nutrition. Blood samples were collected at the ICU from this patient group at three time points (T1-3): T1: within 12 hours after admission; T2: second day morning; T3: third day morning of follow-up. | Other | Sepsis |
| Sepsis-related organ dysfunction therapyPatient management of sepsis and sepsis-related organ dysfunction followed the international guidelines of the 2016 Surviving Sepsis Campaign (SSC) regarding respiratory, antimicrobial, anticoagulation, vasopressor and hydrocortisone therapy, along with adequate fluid resuscitation, sedation, ulcer prophylaxis, nutrition and renal replacement therapy (if needed). In this patient group, blood sampling was performed at three time points (T1-3): T1: within 12 hours after admission; T2: second day morning; T3: third day morning of follow-up. | Other | Sepsis-related organ dysfunction |
Primary outcome
Plasma Presepsin concentrations
Time frame: 3 days
Plasma samples were centrifuged (10 min, 1500 g), then sample aliquots were stored without preservatives at -70 °C until analysis. Plasma presepsin levels were measured using an automated Point of Care instrument (PATHFAST; LSI Medience Corporation, Tokyo, Japan) based on a chemiluminescent enzyme immunoassay.
Serum gelsolin concentrations
Time frame: 3 days
Clotted blood samples were centrifuged (10 min, 1500 g), then sample aliquots were stored without preservatives at -70 °C until analysis. Serum gelsolin levels were determined with an automated immune turbidimetric assay (Cobas 8000/c502 module (Roche Diagnostics GmbH, Mannheim, Germany)).
1 secondary outcome
Presepsin:gelsolin ratios
Time frame: 5 days
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 Apr 2022.
- Derived from this study: PubMed 37215727Ragan D, Kustan P, Horvath-Szalai Z, Szirmay B, Miseta A, Woth G, Koszegi T, Muhl D. Presepsin: gelsolin ratio, as a promising marker of sepsis-related organ dysfunction: a prospective observational study. Front Med (Lausanne). 2023 May 5;10:1126982. doi: 10.3389/fmed.2023.1126982. eCollection 2023.
- 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.
Dániel Ragán, MD principal investigator
Department of Laboratory Medicine, Medical School, University of Pécs
Péter Kustán, MD, PhD principal investigator
Department of Laboratory Medicine, Medical School, University of Pécs
Zoltán Horváth-Szalai, MD, PhD principal investigator
Department of Laboratory Medicine, Medical School, University of Pécs
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 Acute Kidney Injury Due to Sepsis, run by University of Pecs at 1 site in Hungary.
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 3 inclusion and 5 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 Apr 2022. 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 Hungary. 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?
Plasma Presepsin concentrations (time frame: 3 days). The study lists 2 primary outcomes in all. 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 NCT05060679, which also lists 1 linked publication.
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 Apr 2022.