Septic ShockNCT06180265
The Diagnostic and Prognostic Value of Presepsin in Sepsis
A study testing presepsin, procalciton, endotoxin in people with Septic Shock, run by University of Foggia at 1 site in Italy.
Trial summary
Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are used to identify patients at risk of sepsis or to guide proper treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- presepsin, procalciton, endotoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2020to 19 Jul 2023
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- caucasian patients
- patients undergoing laparoscopic major abdominal surgery
Who cannot join
- pregnancy,
- organ transplantation,
- palliative care
- metastatic cancer
- head trauma and polytrauma
- coagulopathies
Show all 10Show fewer
- use of anticoagulants
- neurological disease
- autoimmune disease
- thyroid disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PRESEPSIN: Biomarker in the Early Diagnosis of Sepsis
Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are used to identify patients at risk of sepsis or to guide proper treatment.
No studies compared presepsin to procalcitonin and endotoxin in patients treated with by extracorporeal hemoperfusion with a polymyxin-B-adsorbing cartridge (PMX-HA).
Read the detailed description
Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are used to identify patients at risk of sepsis or to guide proper treatment. Particularly, endotoxin can be removed from the blood by extracorporeal hemoperfusion with a polymyxin-B-adsorbing cartridge (PMX-HA).
No studies compared presepsin to procalcitonin and endotoxin in patients treated with PMX-HA. The investigators aim to evaluate the trend and prognostic value of presepsin versus procalcitonin and endotoxin in ICU patients with septic shock from complicated major abdominal surgery, treated with PMX-HA.
- Conditions
- Septic Shock
- Being tested
- presepsin, procalciton, endotoxin
- Keywords
- septic shock
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
presepsin, procalciton, endotoxinDiagnostic test
measurement of presepsin, procalciton, endotoxin plasmatic levels
| Study group | Role | What they receive |
|---|---|---|
| septic shock patients | Other | Septic shock patients undergoing major abdominal surgery treated with polymyxin-B Receives: Diagnostic Test: presepsin, procalciton, endotoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of mortality at 30-days
incidence of mortality
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Feb 2020
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cotoia Antonella, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180265
- Sponsor's protocol ID
- 8/C.E./2020
- Status last verified
- Dec 2023
- First submitted
- 25 Jul 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRESEPSIN: Biomarker in the Early Diagnosis of Sepsis
- ClinicalTrials.gov ID
- NCT06180265
- Acronym / sponsor ID
- 8/C.E./2020
- Conditions
- Septic Shock
- Keywords
- septic shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 22 Dec 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.
Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are used to identify patients at risk of sepsis or to guide proper treatment.
No studies compared presepsin to procalcitonin and endotoxin in patients treated with by extracorporeal hemoperfusion with a polymyxin-B-adsorbing cartridge (PMX-HA).
Detailed description
Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are used to identify patients at risk of sepsis or to guide proper treatment. Particularly, endotoxin can be removed from the blood by extracorporeal hemoperfusion with a polymyxin-B-adsorbing cartridge (PMX-HA).
No studies compared presepsin to procalcitonin and endotoxin in patients treated with PMX-HA. The investigators aim to evaluate the trend and prognostic value of presepsin versus procalcitonin and endotoxin in ICU patients with septic shock from complicated major abdominal surgery, treated with PMX-HA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| septic shock patients | Other | Diagnostic Test: presepsin, procalciton, endotoxinSeptic shock patients undergoing major abdominal surgery treated with polymyxin-B |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- caucasian patients
- patients undergoing laparoscopic major abdominal surgery
Key exclusion criteria (10 listed)
- pregnancy,
- organ transplantation,
- palliative care
- metastatic cancer
- head trauma and polytrauma
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 |
|---|---|---|
| presepsin, procalciton, endotoxinmeasurement of presepsin, procalciton, endotoxin plasmatic levels | Diagnostic test | septic shock patients |
Primary outcome
incidence of mortality at 30-days
Time frame: up to 30 days
incidence of mortality
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 22 Dec 2023.
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Sepsis
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?
A study testing presepsin, procalciton, endotoxin in people with Septic Shock, run by University of Foggia at 1 site in Italy.
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 2 inclusion and 10 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 22 Dec 2023. 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 Italy. 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?
incidence of mortality at 30-days (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2023.