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NCT Number: NCT06683794

Predicts Mortality by AST/ALT Ration in Patients with Sepsis and Septic Shock During ICU Admissin

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults patients admitted to the ICU with a diagnosis of sepsis or septic shock according to the Surviving Sepsis Campaign criteria. Diagnostic Criteria for Sepsis and Septic Shock (Sepsis-3) Sepsis: Life-threatening organ dysfunction caused by a dysregulated host response to infection. Organ dysfunction is identified as an acute change in total SOFA (Sequential organ failure assessment) score ≥2 points due to infection.

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.

  • Patients with a history of alcohol abuse. 3. Patients on high dose statin therapy. 4. patients with other causes that could raise AST and ALT e,g, rhabdomyolysis, myocardial infarction.
  • Patients with missed data or who couldnt be followed up

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Treatment and study plan

Primary outcomes

  1. The accuracy of the AST/ALT ratio as prognostic factors in patients with sepsis and septic shock

    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.

Secondary outcomes

  1. sensitivity of AST/ALT ratio compare to APACHE II

    Time frame: baseline

    Compare between APACHE II and AST/ALT ratio sensitivity as prognostic factors in patients with sepsis and septic shock.

Study contacts

Contact information is provided by the study sponsor or research team.

Nermeen Gamel Ahmed

CONTACT

[email protected]

01225773059

Sponsors and collaborators

Lead sponsor

Nermeen Gamil Ahmed

Other

Registry information

Official study title

The Prognostic Value of the AST/ALT Ratio Vs. APACHE II Score in Patients with Sepsis and Septic Shock

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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