SepsisNCT05605275
CRP and PCT as Predictors of Sepsis Cause
An observational study of Sepsis and Gram-Positive Bacteremia, run by Osijek University Hospital at 1 site in Croatia.
Trial summary
The aim of this retrospective study is to determine the predictive role of serum level of procalcitonin (PCT) and c-reactive protein (CRP) in determining the causative agent of sepsis in surgical intensive care unit (ICU) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Gram-Positive Bacteremia, Gram-negative Bacteremia
- What is being tested?
- PCT levels, CRP levels and White blood cell count
- How many people
- 81 participants
- Where
- 1 siteCroatia
- Study dates
- 5 Jan 2022to 10 Jul 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years who were hospitalized in the surgical ICU between January 2019 and May 2022 and who had at least one positive blood culture during treatment will be included in the research.
Who may be able to join
- hospitalisation in surgical ICU
- diagnosis of sepsis
- gram+ blood culture isolate
- gram- blood culture isolate
Who cannot join
- younger of 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CRP and PCT as Predictors of Bloodstream Infections in Surgical Patients With Isolation of G+ and G- Bacteria in 3 Year Period
The aim of this retrospective study is to determine the predictive role of serum level of procalcitonin (PCT) and c-reactive protein (CRP) in determining the causative agent of sepsis in surgical intensive care unit (ICU) patients. The main question it aims to answer is: what serum level of PCT and CRP is predictive of gram+ and gram- sepsis in patients with positive blood cultures in the surgical ICU. The study will be retrospective and will include all patients with positive blood cultures who were hospitalized in the surgical ICU of University Hospital Osijek in the period from January 2019 to May 2022.
Read the detailed description
PCT is a good biochemical marker of severe bacterial infection. Numerous studies have confirmed its role in the diagnosis of sepsis, especially sepsis with positive blood cultures. This retrospective study will include septic patients who were hospitalised in the surgical ICU between January 2019 and May 2022, and who had at least one positive blood culture. The values of PCT, CRP, white blood cells count and platelets count, as well as the overall outcome of the treatment, will be recorded for the patients included in the research. The aim of the research is to examine the differences in the level of PCT, CRP, white blood cells count and platelets count between patients with gram+ and gram- blood cultures. Also, the predictive value of PCT and CRP in differentiating gram+ from gram- hem will be examined.
- Conditions
- Sepsis, Gram-Positive Bacteremia, Gram-negative Bacteremia
- Being tested
- PCT levels, CRP levels, White blood cell count, Platelet count
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCT levelsDiagnostic test
All patients will have their serum PCT level recorded on the day of the positive blood culture and in the next three days.
CRP levelsDiagnostic test
All patients will have their serum CRP level recorded on the day of the positive blood culture and in the next three days.
White blood cell countDiagnostic test
All patients will have their white blood cell (WBC) count recorded on the day of the positive blood culture and in the next three days.
Platelet countDiagnostic test
All patients will have their platelets count recorded on the day of the positive blood culture and in the next three days.
| Study group | Role | What they receive |
|---|---|---|
| Gram negative | Patients who had at least one blood culture with a gram- isolate during hospitalisation in the surgical ICU Receives: Diagnostic Test: PCT levels; Diagnostic Test: CRP levels; Diagnostic Test: White blood cell count; Diagnostic Test: Platelet count | |
| Gram positive | Patients who had at least one blood culture with a gram+ isolate during hospitalisation in the surgical ICU Receives: Diagnostic Test: PCT levels; Diagnostic Test: CRP levels; Diagnostic Test: White blood cell count; Diagnostic Test: Platelet count |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive level of PCT
Predictive serum level of PCT in differentiating gram+ from gram- blood culture
Measured: 4 days
Predictive level of CRP
Predictive serum level of CRP in differentiating gram+ from gram- blood culture
Measured: 4 days
Secondary outcomes (4)
White blood cells count
Test for differences in WBC count between patients with gram+ and gram- blood cultures
Measured: 4 days
Platelets count
Test for differences in platelets count between patients with gram+ and gram- blood cultures
Measured: 4 days
PCT levels and outcome
To examine differences in serum PCT levels between patients who survived and those who died
Measured: 4 days
CRP levels and outcome
To examine differences in serum CRP levels between patients who survived and those who died
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start5 Jan 2022
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Other
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nenad Neskovic, PhD, Study chair, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605275
- Sponsor's protocol ID
- PCT retrospective
- Status last verified
- Oct 2022
- First submitted
- 30 Oct 2022
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morgenthaler NG, Struck J, Fischer-Schulz C, Seidel-Mueller E, Beier W, Bergmann A. Detection of procalcitonin (PCT) in healthy controls and patients with local infection by a sensitive ILMA. Clin Lab. 2002;48(5-6):263-70.
PubMed 12071576Assicot M, Gendrel D, Carsin H, Raymond J, Guilbaud J, Bohuon C. High serum procalcitonin concentrations in patients with sepsis and infection. Lancet. 1993 Feb 27;341(8844):515-8. doi: 10.1016/0140-6736(93)90277-n.
PubMed 8094770Sinha M, Desai S, Mantri S, Kulkarni A. Procalcitonin as an adjunctive biomarker in sepsis. Indian J Anaesth. 2011 May;55(3):266-70. doi: 10.4103/0019-5049.82676.
PubMed 21808399Hoeboer SH, van der Geest PJ, Nieboer D, Groeneveld AB. The diagnostic accuracy of procalcitonin for bacteraemia: a systematic review and meta-analysis. Clin Microbiol Infect. 2015 May;21(5):474-81. doi: 10.1016/j.cmi.2014.12.026. Epub 2015 Jan 14.
PubMed 25726038Gupta S, Jaswani P, Sharma RK, Agrawal S, Prasad N, Sahu C, Gupta A, Prasad KN. Procalcitonin as a diagnostic biomarker of sepsis: A tertiary care centre experience. J Infect Public Health. 2019 May-Jun;12(3):323-329. doi: 10.1016/j.jiph.2018.11.004. Epub 2018 Nov 26.
PubMed 30497960Yang L, Lin Y, Wang J, Song J, Wei B, Zhang X, Yang J, Liu B. Comparison of Clinical Characteristics and Outcomes Between Positive and Negative Blood Culture Septic Patients: A Retrospective Cohort Study. Infect Drug Resist. 2021 Oct 12;14:4191-4205. doi: 10.2147/IDR.S334161. eCollection 2021.
PubMed 34675564
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRP and PCT as Predictors of Bloodstream Infections in Surgical Patients With Isolation of G+ and G- Bacteria in 3 Year Period
- ClinicalTrials.gov ID
- NCT05605275
- Acronym / sponsor ID
- PCT retrospective
- Conditions
- Sepsis, Gram-Positive Bacteremia, Gram-negative Bacteremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 4 Nov 2022 (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.
The aim of this retrospective study is to determine the predictive role of serum level of procalcitonin (PCT) and c-reactive protein (CRP) in determining the causative agent of sepsis in surgical intensive care unit (ICU) patients. The main question it aims to answer is: what serum level of PCT and CRP is predictive of gram+ and gram- sepsis in patients with positive blood cultures in the surgical ICU. The study will be retrospective and will include all patients with positive blood cultures who were hospitalized in the surgical ICU of University Hospital Osijek in the period from January 2019 to May 2022.
Detailed description
PCT is a good biochemical marker of severe bacterial infection. Numerous studies have confirmed its role in the diagnosis of sepsis, especially sepsis with positive blood cultures. This retrospective study will include septic patients who were hospitalised in the surgical ICU between January 2019 and May 2022, and who had at least one positive blood culture. The values of PCT, CRP, white blood cells count and platelets count, as well as the overall outcome of the treatment, will be recorded for the patients included in the research. The aim of the research is to examine the differences in the level of PCT, CRP, white blood cells count and platelets count between patients with gram+ and gram- blood cultures. Also, the predictive value of PCT and CRP in differentiating gram+ from gram- hem will be examined.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gram negative | – | Diagnostic Test: PCT levels, Diagnostic Test: CRP levels, Diagnostic Test: White blood cell count, Diagnostic Test: Platelet countPatients who had at least one blood culture with a gram- isolate during hospitalisation in the surgical ICU |
| Gram positive | – | Diagnostic Test: PCT levels, Diagnostic Test: CRP levels, Diagnostic Test: White blood cell count, Diagnostic Test: Platelet countPatients who had at least one blood culture with a gram+ isolate during hospitalisation in the surgical ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years who were hospitalized in the surgical ICU between January 2019 and May 2022 and who had at least one positive blood culture during treatment will be included in the research.
Key inclusion criteria (4 listed)
- hospitalisation in surgical ICU
- diagnosis of sepsis
- gram+ blood culture isolate
- gram- blood culture isolate
Key exclusion criteria (1 listed)
- younger of 18 years old
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 |
|---|---|---|
| PCT levelsAll patients will have their serum PCT level recorded on the day of the positive blood culture and in the next three days. | Diagnostic test | Gram negative, Gram positive |
| CRP levelsAll patients will have their serum CRP level recorded on the day of the positive blood culture and in the next three days. | Diagnostic test | Gram negative, Gram positive |
| White blood cell countAll patients will have their white blood cell (WBC) count recorded on the day of the positive blood culture and in the next three days. | Diagnostic test | Gram negative, Gram positive |
| Platelet countAll patients will have their platelets count recorded on the day of the positive blood culture and in the next three days. | Diagnostic test | Gram negative, Gram positive |
Primary outcome
Predictive level of PCT
Time frame: 4 days
Predictive serum level of PCT in differentiating gram+ from gram- blood culture
Predictive level of CRP
Time frame: 4 days
Predictive serum level of CRP in differentiating gram+ from gram- blood culture
4 secondary outcomes
White blood cells count
Time frame: 4 days
Platelets count
Time frame: 4 days
PCT levels and outcome
Time frame: 4 days
CRP levels and outcome
Time frame: 4 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 18 Jul 2023.
- Background: PubMed 12071576Morgenthaler NG, Struck J, Fischer-Schulz C, Seidel-Mueller E, Beier W, Bergmann A. Detection of procalcitonin (PCT) in healthy controls and patients with local infection by a sensitive ILMA. Clin Lab. 2002;48(5-6):263-70.
- Background: PubMed 8094770Assicot M, Gendrel D, Carsin H, Raymond J, Guilbaud J, Bohuon C. High serum procalcitonin concentrations in patients with sepsis and infection. Lancet. 1993 Feb 27;341(8844):515-8. doi: 10.1016/0140-6736(93)90277-n.
- Background: PubMed 21808399Sinha M, Desai S, Mantri S, Kulkarni A. Procalcitonin as an adjunctive biomarker in sepsis. Indian J Anaesth. 2011 May;55(3):266-70. doi: 10.4103/0019-5049.82676.
- Background: PubMed 25726038Hoeboer SH, van der Geest PJ, Nieboer D, Groeneveld AB. The diagnostic accuracy of procalcitonin for bacteraemia: a systematic review and meta-analysis. Clin Microbiol Infect. 2015 May;21(5):474-81. doi: 10.1016/j.cmi.2014.12.026. Epub 2015 Jan 14.
- Background: PubMed 30497960Gupta S, Jaswani P, Sharma RK, Agrawal S, Prasad N, Sahu C, Gupta A, Prasad KN. Procalcitonin as a diagnostic biomarker of sepsis: A tertiary care centre experience. J Infect Public Health. 2019 May-Jun;12(3):323-329. doi: 10.1016/j.jiph.2018.11.004. Epub 2018 Nov 26.
- Background: PubMed 34675564Yang L, Lin Y, Wang J, Song J, Wei B, Zhang X, Yang J, Liu B. Comparison of Clinical Characteristics and Outcomes Between Positive and Negative Blood Culture Septic Patients: A Retrospective Cohort Study. Infect Drug Resist. 2021 Oct 12;14:4191-4205. doi: 10.2147/IDR.S334161. eCollection 2021.
- 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.
Nenad Neskovic, PhD study chair
Principal Investigator
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 Gram-Positive Bacteremia, run by Osijek University Hospital at 1 site in Croatia.
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 4 inclusion and 1 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 18 Jul 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 Croatia. 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?
Predictive level of PCT (time frame: 4 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 NCT05605275, which also lists 6 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 18 Jul 2023.