Clinical trials on Acute-on-Chronic Liver Failure

Understanding Acute-on-Chronic Liver Failure

Acute-on-Chronic Liver Failure (ACLF) is a complex medical condition characterized by the sudden worsening of chronic liver disease, accompanied by one or more extrahepatic organ failures. This condition is a significant challenge in the field of hepatology, given its high mortality rate and the complexity of its management. ACLF can be triggered by various factors, including bacterial infections, alcohol misuse, reactivation of viral hepatitis, or the use of certain drugs that are toxic to the liver.

The pathophysiology of ACLF involves an exaggerated inflammatory response, leading to a cascade of events that result in organ failures. The clinical presentation of ACLF can vary significantly, but it generally includes jaundice, coagulopathy, ascites, encephalopathy, and renal failure. The management of ACLF requires a multidisciplinary approach, focusing on the treatment of the precipitating event, support of failing organs, and consideration for liver transplantation in eligible patients.

  • Diagnosis: The diagnosis of ACLF is based on clinical criteria, including evidence of chronic liver disease, the acute deterioration of liver function, and the involvement of other organ systems.
  • Treatment: Treatment strategies for ACLF are tailored to the individual patient, depending on the severity of the liver failure and the presence of other organ failures. Supportive care, infection control, and liver transplantation are key components of the management strategy.
  • Prognosis: The prognosis of ACLF is generally poor, with high short-term mortality rates. However, early recognition and aggressive management can improve outcomes for some patients.

In conclusion, ACLF represents a severe and life-threatening condition that demands prompt diagnosis and comprehensive care. The complexity of ACLF necessitates a thorough understanding of its pathophysiology, an aggressive approach to treatment, and a coordinated effort among healthcare professionals to optimize patient outcomes.


Understanding Acute-on-Chronic Liver Failure (ACLF)

Acute-on-Chronic Liver Failure (ACLF) is a severe condition where chronic liver disease worsens suddenly, leading to significant organ failure. The prognosis varies, depending on liver dysfunction severity, other organ failures, and overall health. Generally associated with high short-term mortality, long-term outcomes depend on liver damage extent and treatment response. Some may improve, while others progress to chronic states needing ongoing management. Survival rates are lower than for chronic liver disease alone, underscoring this condition’s critical nature. Each case’s prognosis can significantly differ.

Complications of ACLF

  • Hepatic encephalopathy: Toxin buildup in the blood can cause confusion, sleep disturbances, and coma.
  • Ascites: Fluid accumulation in the abdomen leads to discomfort, breathing difficulty, and infection risk.
  • Bleeding disorders: The liver’s inability to produce clotting factors causes easy bruising or severe bleeding.
  • Hepatorenal syndrome: Compromised kidney function results in fluid retention and electrolyte imbalances.

Managing Acute-on-Chronic Liver Failure

Acute-on-Chronic Liver Failure management benefits from a holistic approach.

  • Dietary adjustments: Eating fruits, vegetables, lean proteins, and whole grains supports liver health. Reducing salt intake and avoiding alcohol and processed foods are crucial.
  • Regular physical activity: Tailored exercises promote well-being and maintain healthy weight. Walking or yoga can be beneficial.
  • Pharmacotherapy options: Healthcare providers may suggest medications to support liver function and reduce symptoms.
  • Modern technology: Mobile apps for diet and medication tracking, along with wearable devices for monitoring vital signs, help stay informed about health status.

Adopting these methods plays a significant role in managing the condition, under professional guidance.

  • CT-EU-00053670

    Comparison of the effectiveness of two drugs in organ transplantation

    This study is looking at a solution called Custodiol-N that is used to keep organs safe while they are being moved for a transplant operation. It will be compared to the usual solution called Custodiol. The study is checking if this new solution is as good, or better, at protecting the organs. The organs that are being studied are the kidney, liver, and pancreas. It’ll take about 3 months to complete the study with each person. Doctors would check on patients for 90 days after the operation to see how they’re recovering. The study will be run in several centers and should finish after roughly 30 months.

    • Custodiol-N Solution
    • Custodiol HTK Solution
  • Testing new medicine for liver cirrhosis with high blood pressure

    This research project focuses on examining a new drug – BI 685509 alone or alongside another drug called empagliflozin. The study wants to find out if these drugs can assist people suffering from cirrhosis of the liver. Cirrhosis is a disease where for liver it gets hard to function properly. It can be caused by viruses like hepatitis B and C or by a condition known as non-alcoholic steatohepatitis (NASH), which is related to fat build-up in the liver. These patients also have high blood pressure in the portal vein, a large vessel that carries blood to the liver. During the study, which lasts for about three months, the patient will have to take BI 685509 tablets two times daily for eight weeks. If the patient has diabetes as well, they will also have to consume empagliflozin once a day. The patient will be required to visit the study site around 10 times, with the occasional use of a slender tube, known as a catheter, to assess the pressure in the liver vein.

    • BI 685509- new potential medication for chronic kidney disease (CKD), portal hypertension, cirrhosis, and diabetic nephropathy
    • Empagliflozin
  • Assessing new treatment effectiveness for adults with liver failure and ascites

    This is a Phase II clinical trial evaluating the efficacy, safety, and tolerability of VS-01 in adult patients with acute or chronic liver failure (ACLF) and ascites. The study is planned to include 60 participants aged 18 to 64. It was designed as a multicenter, randomized, controlled, open-label trial, which means both patients and researchers know who will receive the treatment. Patients are divided into two groups: one receives VS-01 in addition to standard care, and the other receives only standard care. The main aim of the study is to assess the effect of VS-01 on the severity of liver failure and ascites. Key measures include changes in the Chronic Liver Failure Consortium ACLF (CLIF-C) score, survival rates, and the occurrence and severity of any side effects. This test excludes patients with serious complications or other serious health problems.

    • VS-01- new potential medication for acute-on-chronic liver failure and ascites