Health Condition 1: K703- Alcoholic cirrhosis of liver
Conditions
Interventions
Intervention1: sustained low-efficiency dialysis (SLED) with standard medical therapy (SMT):
In the intervention group (SLED plus SMT), participants will have repeated SLED sessions every 48 hours, a
Sponsors
MMCBSY Scheme Govt of Rajasthan
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome is to evaluate the change in serum ammonia levels in each group after the intervention.Timepoint: baseline, 48 hours, 96 hours, 3months, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Baseline and after each dialysis treatment and up to fifth day after hospitalisation | — |
Countries
India
Contacts
Public ContactDr Ashok Jhajharia
SMS Medical College & Hospital
Outcome results
None listed