Acute on Chronic Liver Failure Clinical Trial
Official title:
Lactate Kinetics as a Predictor of Survival in ACLF With Septic Shock: A Prospective Observational Study
Shock is a clinical state of tissue hypoxia. This hypoxia may be brought about by either decreased perfusion or the inability of the cell to extract oxygen in the presence of adequate perfusion. This causes cellular dysfunction. The most encountered form of shock seen in cirrhotics is septic shock. Septic shock has underlying cellular and metabolic abnormalities in addition to circulatory dysfunction. The circulatory dysfunction in sepsis is in the form of severe vasodilatation with high cardiac index. Cirrhosis is a state of hyperdynamic circulation. The mortality of septic shock in these group of patients is still higher. Sepsis-3 definition of septic shock describes it as a dysregulated immune response to an infection, leading to systemic inflammation, vasodilation, and organ impairment (3). Practically, to define septic shock it requires the lactate to be more than 2 mmol/L and there should be requirement of vasopressors after adequate fluid resuscitation. Increased lactate levels can indicate tissue hypoxia, excessively rapid aerobic glycolysis, or reduced clearance. As lactate is a normal product of glucose and pyruvate metabolism, any increase in glucose metabolism and / or decrease in pyruvate metabolism will increase lactate generation. This was observed even in the presence of adequate tissue oxygenation. In sepsis, the inflammatory response appears to be associated with an increase in glycolysis and impaired pyruvate dehydrogenase activity. Thus, cytoplasmic pyruvate increases with greater lactate formation. The glycolytic enzyme complex lactate dehydrogenase (LDH) regenerates nicotinamide adenine dinucleotide (NAD) when pyruvate is reduced to lactate via a redox-coupled process in anaerobic glycolysis (Embden-Meyerhof pathway). Since lactate is overproduced and underutilised in tissue hypoxia due to poor mitochondrial oxidation, lactate has traditionally been used as a diagnostic marker for tissue hypoxia. However, up to 70% of the body's lactate elimination occurs in the liver
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | August 30, 2024 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Patients of Acute on chronic liver failure with septic shock (APASL, Sepsis -3 definitions) 2. Age 18-70yrs 3. Informed Consent Exclusion Criteria: 1. Acute coronary syndrome, hemodynamically unstable arrhythmias 2. CKD stage 5 3. COPD with acute exacerbation 4. Acute CVA or Seizures 5. Extremely moribund patients 6. Hepato-cellular carcinoma (HCC), intrahepatic or extrahepatic malignancy 7. Pregnancy 8. Diabetic ketoacidosis |
Country | Name | City | State |
---|---|---|---|
India | Institute of Liver & Biliary Sciences (ILBS) | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Institute of Liver and Biliary Sciences, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants survived at day 7 | 7 days | ||
Secondary | lactate clearance and delta lactate will be measured --> lactate clearance = (Initial lactate - current lactate) Initial lactate * 100, Delta lactate = Initial lactate - current lactate | 0 hours | ||
Secondary | lactate clearance and delta lactate will be measured --> lactate clearance = (Initial lactate - current lactate) Initial lactate * 100, Delta lactate = Initial lactate - current lactate | 6 hours | ||
Secondary | lactate clearance and delta lactate will be measured --> lactate clearance = (Initial lactate - current lactate) Initial lactate * 100, Delta lactate = Initial lactate - current lactate | 12 hours | ||
Secondary | lactate clearance and delta lactate will be measured --> lactate clearance = (Initial lactate - current lactate) Initial lactate * 100, Delta lactate = Initial lactate - current lactate | 24 hours | ||
Secondary | lactate clearance and delta lactate will be measured --> lactate clearance = (Initial lactate - current lactate) Initial lactate * 100, Delta lactate = Initial lactate - current lactate | 48 hours | ||
Secondary | lactate clearance and delta lactate will be measured --> lactate clearance = (Initial lactate - current lactate) Initial lactate * 100, Delta lactate = Initial lactate - current lactate | 72 hours | ||
Secondary | Impact of delta arterial lactate at 6 hours on length of hospital stay (measured in days). | 28 days | ||
Secondary | Impact of delta arterial lactate at 6 hours on need of invasive ventillation (Yes/no) | 7 days | ||
Secondary | Impact of delta arterial lactate at 6 hours on number of days of invasive ventillation (Measured in days) | 7 days | ||
Secondary | Impact of lactate clearance at 6 hours on length of hospital stay (measured in days). | 28 days | ||
Secondary | impact of lactate clearance at 6 hrs on need of invasive ventillation (Yes/no), | 7 days | ||
Secondary | impact of lactate clearance at 6 hrs on number of days of invasive ventillation (Measured in days) | 7 days | ||
Secondary | Length of hospital stay (measured in days). | 28 days | ||
Secondary | Need of ventilation | 28 days | ||
Secondary | Days of ventilation | 28 days | ||
Secondary | impact of oxygenation measured by PF ratio at 0H on delta lactate at 6 hours | 6 hours | ||
Secondary | Correlation between presence or absence of metabolic acidosis with delta lactate at 6 hours | 6 hours | ||
Secondary | Number of patients with effect of anion gap at 0H if metabolic acidosis is present on the delta lactate at 6 hours | 6 hours | ||
Secondary | Number of patients with effect of ejection fraction / cardiac outout on delta arterial lactate at 6 hours | 6 hours | ||
Secondary | To study the impact of presence or absence of multi drug resistant organism (in culture or PCR anallysis) on delta lactate at 6 hours | 7 days | ||
Secondary | The effect of need of renal replacement therapy (till day 7) on delta lactate at 6 hours | 7 days | ||
Secondary | The effect of number of days of continuous renal replacement therapy (till day7) on delta lactate at 6 hours | 7 days | ||
Secondary | The amount of fluid resuscitated and its effect on delta lactate at 6 hours | 7 days | ||
Secondary | Number of patients with number of patients with Noradrenaline requirement and effect on delta lactate at 6 hours | 7 days | ||
Secondary | To study the effect of lactate kinetics on 28 day mortality and to study the other factors affecting 28 day mortality | 28 days | ||
Secondary | Coerrelation between presence or absence of respiratory acidosis on the delta lactate at 6 hours | 6 hours |
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