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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04105400
Other study ID # PCT value in sepsis
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 1, 2021

Study information

Verified date September 2019
Source Assiut University
Contact mohamed abdelnaser mahmoud Ali, MD
Phone 0882481257
Email doctor4egypt2011@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 1, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Patients above 70 years of age

- Patients who received antibiotic therapy within three days prior to sample collection

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (8)

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. — View Citation

Karlsson S, Heikkinen M, Pettilä V, Alila S, Väisänen 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. — View Citation

Kim 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. — View Citation

Lee 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. — View Citation

Novotny 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. — View Citation

Peters 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. — View Citation

Ruiz-Alvarez MJ, García-Valdecasas S, De Pablo R, Sanchez García 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. — View Citation

Vincent JL, Marshall JC, Namendys-Silva SA, François 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline
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