Impact of Sustained Low Efficiency Dialysis with Standard Medical Therapy versus Standard Medical Therapy alone in the Management of Patients with Chronic Liver Disease, Hyperammonemia and Hepatic Encephalopathy: A Randomized Comparative Study
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- MMCBSY Scheme Govt of Rajasthan
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The main outcome is to evaluate the change in serum ammonia levels in each group after the intervention.
Overview
Brief Summary
Chronic liver disease primarily affects liver cells, leading to impaired ammonia metabolism and resulting in hyperammonemia, which can cause hepatic encephalopathy, cerebral edema, and intracranial hypertension. The exact mechanisms of hepatic encephalopathy are not fully understood, but factors in the blood, such as inflammation, oxidative stress, lactate, and bile acids, play significant roles. Current treatments for hepatic encephalopathy include ammonia-reducing agents like lactulose and rifaximin, and sometimes L-ornithine-L-aspartate for refractory cases. Extracorporeal devices may also help reduce ammonia and other inflammatory markers. Renal replacement therapy (RRT) is used in cirrhotic patients with acute kidney injury or hepatorenal syndrome to manage fluid balance, electrolytes, and solute clearance. However, there are no comparative studies on different RRT modalities for hyperammonemia or hepatic encephalopathy in chronic liver disease patients. This study aims to compare the effectiveness and feasibility of adding sustained low-efficiency dialysis to standard medical therapy versus standard medical therapy alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients who are between 18 and 60 years old and have decompensated chronic liver disease, diagnosed through biochemical, radiological, and endoscopic tests, can participate.
- •They must also have overt hepatic encephalopathy, classified by the West Haven system and HESA, and a serum ammonia level higher than 100 micromoles per liter.
- •Additionally, they need to be able to understand and agree to sign a written informed consent form, either by themselves or through their caregivers.
Exclusion Criteria
- •This study will not include pregnant or breastfeeding women, patients younger than 18 years or older than 60 years, and those who cannot secure adequate vascular access for dialysis.
- •Patients with unstable blood pressure that cannot be managed with medication, those with uncontrolled bleeding disorders or coagulopathy even after treatment, those with active infections or sepsis, and those who refuse or cannot tolerate the procedure will also be excluded.
Outcomes
Primary Outcomes
The main outcome is to evaluate the change in serum ammonia levels in each group after the intervention.
Time Frame: baseline, 48 hours, 96 hours, 3months, 6 months
Secondary Outcomes
- The secondary outcomes of the study are to evaluate the effects of sustained low-efficiency dialysis combined with standard medical therapy on several parameters during the hospital stay. These parameters include changes in hepatic encephalopathy grading according to West Haven and HESA, the number of dialysis sessions, serum lactate and sodium levels, the duration of organ support needs such as ventilation and vasopressors, and changes in serum profiles including INR, bilirubin, albumin, creatinine, potassium, phosphate, and pH. Additionally, the study will assess the feasibility of this treatment approach by monitoring the number of blood transfusions needed, the occurrence of adverse events like coagulopathy, hypotension, and mortality, the need for upgrading antibiotics, study retention and compliance rates, and the average survival time up to three months after hospitalization.(Baseline and after each dialysis treatment and up to fifth day after hospitalisation)
Investigators
Dr Ashok Jhajharia
SMS Medical College & Hospital