E Prognostic Value of the AST/ALT Ratio Vs. APACHE II Score in Patients with Sepsis and Septic ShockNCT06683794
Predicts Mortality by AST/ALT Ration in Patients with Sepsis and Septic Shock During ICU Admissin
An observational study of E Prognostic Value of the AST/ALT Ratio Vs. APACHE II Score in Patients with Sepsis and Septic Shock, run by Nermeen Gamil Ahmed.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- E Prognostic Value of the AST/ALT Ratio Vs. APACHE II Score in Patients with Sepsis and Septic Shock
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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)
Who may be able to join
- 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.
- 2. 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.
- 4. Patients with missed data or who couldnt be followed up
- -
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Prognostic Value of the AST/ALT Ratio Vs. APACHE II Score in Patients with Sepsis and Septic Shock
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.
Read the detailed description
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.
- Conditions
- E Prognostic Value of the AST/ALT Ratio Vs. APACHE II Score in Patients with Sepsis and Septic Shock
- Keywords
- AST/ALT ratio
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of the AST/ALT ratio as prognostic factors in patients with sepsis and septic shock
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.
Measured: During duration of ICU admission and for 1 month after discharge
Secondary outcomes (1)
sensitivity of AST/ALT ratio compare to APACHE II
Compare between APACHE II and AST/ALT ratio sensitivity as prognostic factors in patients with sepsis and septic shock.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E Prognostic Value of the AST/ALT Ratio Vs. APACHE II Score in Patients with Sepsis and Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nermeen Gamil Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nermeen Gamil Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683794
- Sponsor's protocol ID
- AST/ALT VS APACHE II in Predic
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of the AST/ALT Ratio Vs. APACHE II Score in Patients with Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT06683794
- Acronym / sponsor ID
- AST/ALT VS APACHE II in Predic
- Conditions
- E Prognostic Value of the AST/ALT Ratio Vs. APACHE II Score in Patients with Sepsis and Septic Shock
- Keywords
- AST/ALT ratio
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Nermeen Gamil AhmedUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (6 listed)
- 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.
- 2. 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.
- 4. Patients with missed data or who couldnt be followed up
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
sensitivity of AST/ALT ratio compare to APACHE II
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of E Prognostic Value of the AST/ALT Ratio Vs. APACHE II Score in Patients with Sepsis and Septic Shock, run by Nermeen Gamil Ahmed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nermeen Gamel Ahmed (01225773059, nermeengamel514@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.