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- Essai clinique NCT01708772
Serum TNF-a in Comparison to Sequential Organ Failure Assessment (SOFA) Score Monitoring in Critically Ill Patients
6 juin 2013 mis à jour par: Ayman Abd Al-maksoud Yousef, Tanta University
The Predictive Prognostic Values of Serum TNF-a in Comparison to SOFA Score Monitoring in Critically Ill Patients
A total of ninety patients (52men and 38women) were included in the study.
Forty five patients developed septic complication during ICU stay (sepsis group).
Forty five patients were critically ill without evidence of infectious organism (SIRS group).
At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis were measured.
Routine cultures were obtained.
The attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.
A serum level of TNF-a and SOFA score was monitored.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
The patients staying in ICU for more than 24 hours were enrolled in the study.
Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation were excluded from the study.
At admission, patient's age, sex, weight and height were recorded.
Patients data that include the clinical status; sequential organ failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure; central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis were measured.
Routine cultures of suspected sites, blood and urine were obtained to determine the presence of infection.
We attempted to maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o.
When needed, intravascular fluid replacement, blood products and inotropic or vasopressor agents were administered.
Each day the attending physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.
Type d'étude
Observationnel
Inscription (Réel)
90
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Algharbiya
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Tanta, Algharbiya, Egypte, 35217
- Tanta University
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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 60 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
A total of ninety patients (52men and 38women) were included in the study.
Forty five patients developed septic complication during ICU stay (sepsis group).
Forty five patients were critically ill without evidence of infectious organism (SIRS group).
Patients were classified into their groups at the time of the first blood analysis for these biomarkers at ICU admission.
La description
Inclusion Criteria:
- The patients staying in ICU for more than 24 hours were enrolled in the study.
Exclusion Criteria:
- The Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure;
- Patients received massive blood transfusion;
- Patients with radiation therapy and patients with previous organ transplantation were excluded from the study.
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
Cohortes et interventions
Groupe / Cohorte |
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Sepsis
Forty five patients developed septic complication during ICU stay (sepsis group).
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SIRS group
Forty five patients were critically ill without evidence of infectious organism (SIRS group).
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
TNF-a determination using ELISA.
Délai: Participants will be followed for the duration of ICU stay, At admission, 3rd, 5th and 7th day of ICU stay.Patients will be followed for at least 2 weeks.
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A serum level of TNF-a was determined by quantitative sandwich enzyme immunoassay (R&D Systems, Inc., Minneapolis, MN, USA) guided by to the manufacturer's instructions.
The intensity of the color was measured at 490 nm.
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Participants will be followed for the duration of ICU stay, At admission, 3rd, 5th and 7th day of ICU stay.Patients will be followed for at least 2 weeks.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Evaluation of SOFA score:
Délai: Participants will be followed for the duration of ICU stay, at admission, 3rd, 5th, and 7th day of ICU stay.Patients will be followed for at least 2 weeks.
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SOFA score is composed of scores of six organ systems (respiratory [R], cardiovascular [C], hepatic [H], coagulation [Co], renal [Re], and neurological [N]) graded from 0 to 4 according to the degree of dysfunction/ failure.
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Participants will be followed for the duration of ICU stay, at admission, 3rd, 5th, and 7th day of ICU stay.Patients will be followed for at least 2 weeks.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Ayman A Yousef, MD, Assistant professor os Anesthesia and ICU, Faculty of Medicine, Tanta university
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.
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
1 novembre 2012
Achèvement primaire (Réel)
1 décembre 2012
Achèvement de l'étude (Réel)
1 janvier 2013
Dates d'inscription aux études
Première soumission
10 octobre 2012
Première soumission répondant aux critères de contrôle qualité
16 octobre 2012
Première publication (Estimation)
17 octobre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
7 juin 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juin 2013
Dernière vérification
1 juin 2013
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1381/09/12
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 .