NAI (Nogapendekin Alfa Inbakicept) Plus Standard of Care in Critically Ill Adults With Sepsis
NCT07783789
Critical Illness, Disease Attributes
View Trial DetailsNCT Number: NCT07812051
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
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.
Assiut University
Other
Evaluation of the Prognostic Value of Changes in Ionized Calcium as a Severity Marker in Septic Shock Patients in the Intensive Care Unit
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