Sepsis, SevereNCT04105400
Procalcitonin in Diagnosis of Sepsis in Critically Ill Patient
An observational study of Sepsis, Severe, run by Assiut University.
Trial summary
correlation between procalcitonin levels and the severity of sepsis and it's possibility to be used as a prognostic marker in patients with sepsis and severe sepsis Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Severe
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Dec 2021
- How long will I take part?
- 10 Days
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients will be subjected to: * Full history \& clinical examination. * Routine laboratory investigations including: * Complete blood count (CBC), with special attention to white blood cells (number \& diff.) * Serum C-reactive protein (CRP) level * Erythrocyte sedimentation rate (ESR) Special investigations: ● Blood culture : Blood culture will be processed using the Bact/Alert continuous blood culture monitoring system. Bacteria from positive blood cultures will further identified using standard laboratory methods. Cultures that did not indicate growth within 5 days of incubation will be considered negative. ● Serum procalcitonin will be estimated by ELISA kit.
Who may be able to join
- adult patients >18 years who were admitted to intensive care unit of Assiut University Hospital with symptoms of systemic infection and with a clinical suspicion of sepsis as guided by the ICU physician
Who cannot join
- Patients above 70 years of age
- Patients who received antibiotic therapy within three days prior to sample collection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Procalcitonin as an Early Marker in Diagnosis of Sepsis in Critically Ill Patient
correlation between procalcitonin levels and the severity of sepsis and it's possibility to be used as a prognostic marker in patients with sepsis and severe sepsis
Read the detailed description
Sepsis is the systemic response to infection by microbial organisms and is considered the leading cause of mortality in patients admitted to intensive care units (ICUs). Audits of ICU worldwide showed that 29.5% patients had sepsis on admission or during the ICU stay The signs and symptoms of sepsis are highly variable and are influenced by many factors, including the virulence and bioburden of the pathogen, the portal of entry, and the host susceptibility.
Early diagnosis of sepsis is often difficult in clinical practice, whilst it can be vital for positive patient outcomes in sepsis management. Any delay in diagnosis and treatment may lead to significant organ failure and can be associated with elevated mortality rates.
Rapid effective management of sepsis not only allows for prompt antibiotic therapy and a potential reduction in mortality, it can also minimize the unnecessary use of antibiotics.
Historically, blood cultures have been the gold standard for diagnosing sepsis, however the lenthy time to generate results is a limitation. Additionally, many patients may have already been prescribed antibiotics prior to arrival to the hospital, which may mask the presentation of sepsis in the blood culture. Despite an emphasis on isolating a specific micro organism, on average, only 34% of blood cultures are found to be positive in septic patients Therefore, while it can be useful, relying on the bacteriological diagnosis can be misleading or too late. A number of the inflammatory markers, such as leukocyte cell count, C reactive protein (CRP), and cytokines (TNF-α, IL-1β, or IL-6), have been applied in the diagnosis of inflammation and infection, but their lack of specificity has generated a continued interest to develop more specific clinical laboratory tests One promising marker has been procalcitonin (PCT), whose concentration has been found to be elevated in sepsis. Owing its specificity to bacterial infections, PCT has been proposed as a pertinent marker in the rapid diagnosis of bacterial infection, especially for use in hospital emergency departments and intensive care units.
PCT has been used as marker of sepsis with sensitivity and specificity of 83% and 62% respectively with significantly high levels in the patients having sepsis and positive blood culture results than with culture negative results PCT is a glycoprotein present in C cells of thyroid gland. It belongs to the group of related peptide (C-GRP) encoded by the CALC-1 gene and is formed from the common precursor pre-calcitonin. In healthy subjects, CALC-1 genes synthesize calcitonin, but presence of microbial infection through endotoxin or proinflammatory cytokines increases calcitonin gene expression and PCT mRNA is mostly synthesized. This lead to release of PCT from all parenchymal tissue, exclusively in response to bacterial infection only and not viral or inflammatory disease Previous studies have demonstrated that procalcitonin levels are correlated with the severity of sepsis and could potentially be used as a prognostic marker in patients with sepsis and severe sepsis In this study we evaluated the usefulness of procalcitonin as a diagnostic predictive marker of bacteremia and sepsis in critically ill patients. Serum PCT levels area useful diagnostic tool available to physicians that can help as a marker of sepsis, as well as other bacterial infections. Combination of emerging new biomarkers with PCT could be used in terms of good clinical judgement based on which antimicrobial therapy may suggested, thus reducing the prescription and duration of antibiotic treatment .
- Conditions
- Sepsis, Severe
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
role of procalcitonin in early diagnosis of sepsis
Descriptive cross sectional study would be conducted on adult patients >18 years who were admitted to intensive care unit of Assiut University Hospital with symptoms of systemic infection and with a clinical suspicion of sepsis as guided by the ICU physician
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sepsis, SevereStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelnasser Mahmoud Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105400
- Sponsor's protocol ID
- PCT value in sepsis
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Granic M, Zdravkovic D, Krstajic S, Kostic S, Simic A, Sarac M, Ivanovic N, Radovanovic D, Dikic S, Kovcin V. Totally implantable central venous catheters of the port-a-cath type: complications due to its use in the treatment of cancer patients. J BUON. 2014 Jul-Sep;19(3):842-6.
PubMed 25261677Vincent JL, Marshall JC, Namendys-Silva SA, Francois B, Martin-Loeches I, Lipman J, Reinhart K, Antonelli M, Pickkers P, Njimi H, Jimenez E, Sakr Y; ICON investigators. Assessment of the worldwide burden of critical illness: the intensive care over nations (ICON) audit. Lancet Respir Med. 2014 May;2(5):380-6. doi: 10.1016/S2213-2600(14)70061-X. Epub 2014 Apr 14.
PubMed 24740011Karlsson S, Heikkinen M, Pettila V, Alila S, Vaisanen S, Pulkki K, Kolho E, Ruokonen E; Finnsepsis Study Group. Predictive value of procalcitonin decrease in patients with severe sepsis: a prospective observational study. Crit Care. 2010;14(6):R205. doi: 10.1186/cc9327. Epub 2010 Nov 15.
PubMed 21078153Ruiz-Alvarez MJ, Garcia-Valdecasas S, De Pablo R, Sanchez Garcia M, Coca C, Groeneveld TW, Roos A, Daha MR, Arribas I. Diagnostic efficacy and prognostic value of serum procalcitonin concentration in patients with suspected sepsis. J Intensive Care Med. 2009 Jan-Feb;24(1):63-71. doi: 10.1177/0885066608327095. Epub 2008 Dec 2.
PubMed 19054806Kim JH, Seo JW, Mok JH, Kim MH, Cho WH, Lee K, Kim KU, Jeon D, Park HK, Kim YS, Kim HH, Lee MK. Usefulness of plasma procalcitonin to predict severity in elderly patients with community-acquired pneumonia. Tuberc Respir Dis (Seoul). 2013 May;74(5):207-14. doi: 10.4046/trd.2013.74.5.207. Epub 2013 May 31.
PubMed 23750168Novotny A, Emmanuel K, Matevossian E, Kriner M, Ulm K, Bartels H, Holzmann B, Weighardt H, Siewert JR. Use of procalcitonin for early prediction of lethal outcome of postoperative sepsis. Am J Surg. 2007 Jul;194(1):35-9. doi: 10.1016/j.amjsurg.2006.10.026.
PubMed 17560906Lee CC, Chen SY, Tsai CL, Wu SC, Chiang WC, Wang JL, Sun HY, Chen SC, Chen WJ, Hsueh PR. Prognostic value of mortality in emergency department sepsis score, procalcitonin, and C-reactive protein in patients with sepsis at the emergency department. Shock. 2008 Mar;29(3):322-7. doi: 10.1097/shk.0b013e31815077ca.
PubMed 17724429Peters RP, Twisk JW, van Agtmael MA, Groeneveld AB. The role of procalcitonin in a decision tree for prediction of bloodstream infection in febrile patients. Clin Microbiol Infect. 2006 Dec;12(12):1207-13. doi: 10.1111/j.1469-0691.2006.01556.x.
PubMed 17121627
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Procalcitonin as an Early Marker in Diagnosis of Sepsis in Critically Ill Patient
- ClinicalTrials.gov ID
- NCT04105400
- Acronym / sponsor ID
- PCT value in sepsis
- Conditions
- Sepsis, Severe
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 26 Sep 2019 (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.
correlation between procalcitonin levels and the severity of sepsis and it's possibility to be used as a prognostic marker in patients with sepsis and severe sepsis
Detailed description
Sepsis is the systemic response to infection by microbial organisms and is considered the leading cause of mortality in patients admitted to intensive care units (ICUs). Audits of ICU worldwide showed that 29.5% patients had sepsis on admission or during the ICU stay The signs and symptoms of sepsis are highly variable and are influenced by many factors, including the virulence and bioburden of the pathogen, the portal of entry, and the host susceptibility.
Early diagnosis of sepsis is often difficult in clinical practice, whilst it can be vital for positive patient outcomes in sepsis management. Any delay in diagnosis and treatment may lead to significant organ failure and can be associated with elevated mortality rates.
Rapid effective management of sepsis not only allows for prompt antibiotic therapy and a potential reduction in mortality, it can also minimize the unnecessary use of antibiotics.
Historically, blood cultures have been the gold standard for diagnosing sepsis, however the lenthy time to generate results is a limitation. Additionally, many patients may have already been prescribed antibiotics prior to arrival to the hospital, which may mask the presentation of sepsis in the blood culture. Despite an emphasis on isolating a specific micro organism, on average, only 34% of blood cultures are found to be positive in septic patients Therefore, while it can be useful, relying on the bacteriological diagnosis can be misleading or too late. A number of the inflammatory markers, such as leukocyte cell count, C reactive protein (CRP), and cytokines (TNF-α, IL-1β, or IL-6), have been applied in the diagnosis of inflammation and infection, but their lack of specificity has generated a continued interest to develop more specific clinical laboratory tests One promising marker has been procalcitonin (PCT), whose concentration has been found to be elevated in sepsis. Owing its specificity to bacterial infections, PCT has been proposed as a pertinent marker in the rapid diagnosis of bacterial infection, especially for use in hospital emergency departments and intensive care units.
PCT has been used as marker of sepsis with sensitivity and specificity of 83% and 62% respectively with significantly high levels in the patients having sepsis and positive blood culture results than with culture negative results PCT is a glycoprotein present in C cells of thyroid gland. It belongs to the group of related peptide (C-GRP) encoded by the CALC-1 gene and is formed from the common precursor pre-calcitonin. In healthy subjects, CALC-1 genes synthesize calcitonin, but presence of microbial infection through endotoxin or proinflammatory cytokines increases calcitonin gene expression and PCT mRNA is mostly synthesized. This lead to release of PCT from all parenchymal tissue, exclusively in response to bacterial infection only and not viral or inflammatory disease Previous studies have demonstrated that procalcitonin levels are correlated with the severity of sepsis and could potentially be used as a prognostic marker in patients with sepsis and severe sepsis In this study we evaluated the usefulness of procalcitonin as a diagnostic predictive marker of bacteremia and sepsis in critically ill patients. Serum PCT levels area useful diagnostic tool available to physicians that can help as a marker of sepsis, as well as other bacterial infections. Combination of emerging new biomarkers with PCT could be used in terms of good clinical judgement based on which antimicrobial therapy may suggested, thus reducing the prescription and duration of antibiotic treatment .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will be subjected to: * Full history \& clinical examination. * Routine laboratory investigations including: * Complete blood count (CBC), with special attention to white blood cells (number \& diff.) * Serum C-reactive protein (CRP) level * Erythrocyte sedimentation rate (ESR) Special investigations: ● Blood culture : Blood culture will be processed using the Bact/Alert continuous blood culture monitoring system. Bacteria from positive blood cultures will further identified using standard laboratory methods. Cultures that did not indicate growth within 5 days of incubation will be considered negative. ● Serum procalcitonin will be estimated by ELISA kit.
Key inclusion criteria (1 listed)
- adult patients >18 years who were admitted to intensive care unit of Assiut University Hospital with symptoms of systemic infection and with a clinical suspicion of sepsis as guided by the ICU physician
Key exclusion criteria (2 listed)
- Patients above 70 years of age
- Patients who received antibiotic therapy within three days prior to sample collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
role of procalcitonin in early diagnosis of sepsis
Time frame: Baseline
Descriptive cross sectional study would be conducted on adult patients >18 years who were admitted to intensive care unit of Assiut University Hospital with symptoms of systemic infection and with a clinical suspicion of sepsis as guided by the ICU physician
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Background: PubMed 25261677Granic M, Zdravkovic D, Krstajic S, Kostic S, Simic A, Sarac M, Ivanovic N, Radovanovic D, Dikic S, Kovcin V. Totally implantable central venous catheters of the port-a-cath type: complications due to its use in the treatment of cancer patients. J BUON. 2014 Jul-Sep;19(3):842-6.
- Background: PubMed 24740011Vincent JL, Marshall JC, Namendys-Silva SA, Francois B, Martin-Loeches I, Lipman J, Reinhart K, Antonelli M, Pickkers P, Njimi H, Jimenez E, Sakr Y; ICON investigators. Assessment of the worldwide burden of critical illness: the intensive care over nations (ICON) audit. Lancet Respir Med. 2014 May;2(5):380-6. doi: 10.1016/S2213-2600(14)70061-X. Epub 2014 Apr 14.
- Background: PubMed 21078153Karlsson S, Heikkinen M, Pettila V, Alila S, Vaisanen S, Pulkki K, Kolho E, Ruokonen E; Finnsepsis Study Group. Predictive value of procalcitonin decrease in patients with severe sepsis: a prospective observational study. Crit Care. 2010;14(6):R205. doi: 10.1186/cc9327. Epub 2010 Nov 15.
- Background: PubMed 19054806Ruiz-Alvarez MJ, Garcia-Valdecasas S, De Pablo R, Sanchez Garcia M, Coca C, Groeneveld TW, Roos A, Daha MR, Arribas I. Diagnostic efficacy and prognostic value of serum procalcitonin concentration in patients with suspected sepsis. J Intensive Care Med. 2009 Jan-Feb;24(1):63-71. doi: 10.1177/0885066608327095. Epub 2008 Dec 2.
- Background: PubMed 23750168Kim JH, Seo JW, Mok JH, Kim MH, Cho WH, Lee K, Kim KU, Jeon D, Park HK, Kim YS, Kim HH, Lee MK. Usefulness of plasma procalcitonin to predict severity in elderly patients with community-acquired pneumonia. Tuberc Respir Dis (Seoul). 2013 May;74(5):207-14. doi: 10.4046/trd.2013.74.5.207. Epub 2013 May 31.
- Background: PubMed 17560906Novotny A, Emmanuel K, Matevossian E, Kriner M, Ulm K, Bartels H, Holzmann B, Weighardt H, Siewert JR. Use of procalcitonin for early prediction of lethal outcome of postoperative sepsis. Am J Surg. 2007 Jul;194(1):35-9. doi: 10.1016/j.amjsurg.2006.10.026.
- Background: PubMed 17724429Lee CC, Chen SY, Tsai CL, Wu SC, Chiang WC, Wang JL, Sun HY, Chen SC, Chen WJ, Hsueh PR. Prognostic value of mortality in emergency department sepsis score, procalcitonin, and C-reactive protein in patients with sepsis at the emergency department. Shock. 2008 Mar;29(3):322-7. doi: 10.1097/shk.0b013e31815077ca.
- Background: PubMed 17121627Peters RP, Twisk JW, van Agtmael MA, Groeneveld AB. The role of procalcitonin in a decision tree for prediction of bloodstream infection in febrile patients. Clin Microbiol Infect. 2006 Dec;12(12):1207-13. doi: 10.1111/j.1469-0691.2006.01556.x.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, Severe, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed abdelnaser mahmoud Ali, MD (0882481257 ext. 01023214638, doctor4egypt2011@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
role of procalcitonin in early diagnosis of sepsis (time frame: Baseline). 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 NCT04105400, which also lists 8 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 30 Sep 2019.