Immune Dysregulation During Sepsis: A Natural History Cohort
NCT07735741
Infections, Inflammation
Falls Church, Virginia, United States
View Trial DetailsNCT Number: NCT06683794
1_The study predicts mortality by using Asparate aminotransferase (AST) to Alanine aminotransferase (ALT) ratio in patients with sepsis and septic shock during the duration of ICU admission and for one month after discharge.
2- Compare between APACHE II and AST/ALT ratio as prognostic factors in patients with sepsis and septic shock.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Sepsis is characterized by dysregulated host responses to an infection and may lead to life-threatening organ dysfunctions. Despite recent improvements in the therapy of sepsis including early-goal-directed therapy and improved adherence to treatment guidelines, sepsis is still associated with significant morbidity and mortality. Clinical evidence has shown that hepatic dysfunction is an early event in sepsis, and is an independent risk factor for poor outcome. Clinical manifestations of sepsis-associated liver dysfunction include hypoxic hepatitis, sepsis-induced cholestasis and dysfunction of protein synthesis manifesting with, e.g., coagulopathies . Aspartate aminotransferase (AST) is present in both the cytoplasm and mitochondria of tissue cells, such as the liver, skeletal muscle, heart, brain, and even the kidney, whereas alanine transaminase (ALT) is predominantly located in the cytoplasm of liver tissue. It is thought that ALT primarily reflects liver-specific malfunction, whereas AST may indicate mitochondrial dysfunction resulting from oxidative stress in other tissues to a certain degree. Increases in the AST/ALT ratio indicates systemic derangements such as increased oxidative stress, inflammatory response, and ischemic-reperfusion injury , but might also play a role in more systemic derangements such as increased oxidative stress, inflammatory response, and ischemic-reperfusion injury Limited data regarding the prognostic value of the AST/ALT ratio in patients suffering from sepsis or septic shock is available . The APACHE II (Acute Physiology and Chronic Health Evaluation II) score is a severity-of-disease classification system used to assess the prognosis of critically ill patients. It was developed to predict the risk of hospital mortality and is commonly used in intensive care units (ICUs) to evaluate the severity of illness in adult patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Septic Shock: A subset of sepsis where underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality. Patients with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial pressure (MAP) of 65 mm Hg or greater and a serum lactate level >2 mmol/L in the absence of hypovolemia.
Exclusion criteria
Patients with pre-existing liver disease e.g. chronic hepatitis or cirrhosis.
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Time frame: During duration of ICU admission and for 1 month after discharge
The accuracy of using Asparate aminotransferase (AST) to Alanine aminotransferase (ALT) ratio in patients with sepsis and septic shock to predict mortality during the duration of ICU admission and for one month after discharge.
Time frame: baseline
Compare between APACHE II and AST/ALT ratio sensitivity as prognostic factors in patients with sepsis and septic shock.
Contact information is provided by the study sponsor or research team.
Nermeen Gamil Ahmed
Other
The Prognostic Value of the AST/ALT Ratio Vs. APACHE II Score in Patients with Sepsis and Septic Shock
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