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- Registre américain des essais cliniques
- Essai clinique NCT07812051
Ionized Calcium as a Severity Marker in Septic Shock Patients
Evaluation of the Prognostic Value of Changes in Ionized Calcium as a Severity Marker in Septic Shock Patients in the Intensive Care Unit
Sepsis is a serious condition where the body has an extreme, dysregulated response to an infection, often leading to life-threatening organ dysfunction. Low levels of ionized calcium (the active, free form of calcium in the blood) are common in critically ill patients admitted to intensive care units (ICUs). While established clinical scoring systems like the Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) help assess illness severity, there is a continuous need for rapid, cost-effective biological markers that can be measured immediately at the bedside using routine blood gas analyzers.
The primary purpose of this observational study is to evaluate whether ionized calcium levels measured upon admission to the ICU can serve as an early marker of disease severity and outcome in adult patients diagnosed with sepsis or septic shock.
Adult participants diagnosed with sepsis or septic shock who are admitted to the ICU will receive standard medical care. Routine arterial or venous blood samples will be analyzed at admission to measure ionized calcium and other standard laboratory markers. Researchers will correlate these calcium levels with baseline illness severity scores (SOFA and APACHE II) and evaluate patient outcomes, including 28-day mortality, length of ICU stay, and the need for mechanical ventilation or vasopressor medications.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Adult patients aged 18 years or older
- Diagnosed with sepsis or septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)
- Admission to the intensive care unit (ICU) within 24 hours of presentation
Exclusion Criteria:
- Known pre-existing disorders of calcium or parathyroid metabolism (e.g., chronic hypoparathyroidism, hyperparathyroidism)
- Severe chronic kidney disease (CKD stage 4 or 5) or end-stage renal disease on dialysis
- Patients receiving active intravenous calcium, bisphosphonates, or vitamin D supplementation within 48 hours prior to admission
- Massive blood transfusion (more than 4 units of packed red blood cells) within 6 hours of admission (due to citrate-induced hypocalcemia)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Sepsis and Septic Shock Cohort
Adult patients (aged 18 years or older) diagnosed with sepsis or septic shock according to the Sepsis-3 definitions and admitted to the intensive care unit (ICU) within 24 hours of presentation.
Patients receive standard, evidence-based supportive care.
Ionized calcium levels along with arterial blood gases, organ failure scores (SOFA and APACHE II), and baseline laboratory parameters are assessed upon admission and monitored at 24 and 48 hours to evaluate prognostic outcomes.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Correlation Between Admission Ionized Calcium Levels and SOFA Score
Délai: Baseline
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Correlation between baseline ionized calcium levels and disease severity assessed by the Sequential Organ Failure Assessment (SOFA) score.
Scores range from 0 to 24, where higher scores indicate greater organ failure.
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Baseline
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Attributs de la maladie
- Maladies métaboliques
- Infections
- Syndrome de réponse inflammatoire systémique
- Inflammation
- Déséquilibre eau-électrolyte
- Choc
- Troubles du métabolisme calcique
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Maladie critique
- État septique
- Choc, Septique
- Hypocalcémie
Autres numéros d'identification d'étude
- Ionized Calcium in Sepsis ICU
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