Microcirculatory Alteration and Biomarkers: New Approach for Early Assessment of Septic Multi-organ Dysfunction
The aim of this study is to investigate associations between early structural cellular injury and microvascular alteration with progression of septic organ dysfunction according to total SOFA-Score (an ICU-scoring system - the Sequential Organ Failure Assessment Score). Patients will be monitored for renal (TIMP-2, IGFBP7), and intestinal biomarkers (plasma i-FABP) in conjunction with kidney and muscle vascular bed microvascular perfusion analysis assessed by contrast-enhanced ultrasonography (CEUS). In parallel, a comprehensive analysis of patients' immunological status will be conducted using an established, on-site immune monitoring panel.
The ultimate goal of this study is an early identification of septic patients developing multiorgan dysfunction which may facilitate a timely novel intervention in the future to improve outcome.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Bavaria
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Regensburg, Bavaria, Allemagne, 93053
- Department of Surgery, University Hospital Regensburg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Patients ≥18 years of age with severe sepsis and fulfill the following criteria at the admission to ICU:
- Peritonitis (abdominal infection) and performed source control (either surgically or interventionally)
- 2 or more criteria for systemic inflammatory response syndrome (temperature >38° or<36°; heart rate >90 beats per minute; respiratory rate >20 breaths per minute or paCO2 <32 mmHg; white blood cell count >12,000/mm3, <4000mm3 or >10% immature forms) and serum lactate level of 4mmol/l and more or refractory hypotension - mean arterial pressure <65mmHg or systolic blood pressure <90mmHg after fluid challenge of 1000ml or more /30min
- Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Written informed consent prior to any study procedures
Exclusion Criteria:
- Pre-existing renal-replacement therapy in the pre-operative course
- Pre-existing shock
- Acute coronary syndrome
- Active hemorrhage
- Trauma
- Known allergy to ultrasound contrast media
- Anemia with hemoglobin concentration < 7g/dl
- Patients not able to give written informed consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Assessment of early post-operative course of novel cellular injury biomarkers as well as microvascular perfusion in critically ill patients with severe sepsis and to collection any first evidence of the association of these markers with the SOFA-Score
Délai: 60 weeks
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60 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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28 day mortality
Délai: 60 weeks
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60 weeks
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90 day mortality
Délai: 60 weeks
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60 weeks
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Length of ICU stay
Délai: 60 weeks
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60 weeks
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Length of hospital stay
Délai: 60 weeks
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60 weeks
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Early post-operative course of microvascular perfusion of the kidney and muscle vasculature bed using CEUS
Délai: 60 weeks
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60 weeks
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|
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Incidence of acute kidney injury (AKI) within the first 48 hours as based on current Kidney Disease: Improving Global Outcomes (KDIGO) recommendation
Délai: 60 weeks
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60 weeks
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Incidence of acute kidney injury (AKI) within the first 7 days as based on current Kidney Disease: Improving Global Outcomes (KDIGO) recommendation
Délai: 60 weeks
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60 weeks
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Need for renal replacement therapy (RRT) after admission to ICU
Délai: 60 weeks
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60 weeks
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Identification of an "immunological fingerprint" indicating multi-organ dysfunction
Délai: 60 weeks
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Flow cytometry
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60 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marc H Dahlke, Prof. Dr., University Hospital Regensburg
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Mibisep
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