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Procalcitonin in Diagnosis of Sepsis in Critically Ill Patient

26 septembre 2019 mis à jour par: Mohamed Abdelnasser Mahmoud Ali, Assiut University

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

Aperçu de l'étude

Statut

Inconnue

Les conditions

Description détaillée

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 .

Type d'étude

Observationnel

Inscription (Anticipé)

80

Contacts et emplacements

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Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
role of procalcitonin in early diagnosis of sepsis
Délai: 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
Baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

1 novembre 2019

Achèvement primaire (Anticipé)

1 novembre 2021

Achèvement de l'étude (Anticipé)

1 décembre 2021

Dates d'inscription aux études

Première soumission

25 septembre 2019

Première soumission répondant aux critères de contrôle qualité

25 septembre 2019

Première publication (Réel)

26 septembre 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 septembre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 septembre 2019

Dernière vérification

1 septembre 2019

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • PCT value in sepsis

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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