Status:
WITHDRAWN
GELSECTAN® and Covert Hepatic Encephalopathy
Lead Sponsor:
Consorci Sanitari de l'Alt Penedès i Garraf
Conditions:
Covert Hepatic Encephalopathy
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Randomized crossover pilot clinical trial in which 10 cirrhotic patients with covert hepatic encephalopathy (CHE) will be assigned to take GELSECTAN® (TID) or placebo for 30 days. After a washout peri...
Eligibility Criteria
Inclusion
- Age between 18 and 85 years.
- Liver cirrhosis defined by a previous liver biopsy or by clinical data.
- Presence of minimal hepatic encephalopathy (MHE) defined by two psychometric methods (PHES and / or S-ANT and / or Sloop-test).
- Adequately informed patients who grant their written consent to participate in the study.
Exclusion
- Alternative neurological diagnosis.
- Hepatic encephalopathy stage ≥2 using the adapted West-Haven scale.
- Terminal disease. At the discretion of the doctor, where the patient is in an irreversible situation, in which hepatic encephalopathy is a final manifestation.
- Presence of Acute-on-chronic liver failure defined by the presence of decompensated liver cirrhosis with severe organ or multi-organ failure.
- MELD score greater than 25 at the time of inclusion.
- Hospitalization for any reason.
- Neurological or psychiatric comorbidity that makes the evaluation of hepatic encephalopathy difficult. This includes patients with mental illnesses (dementia, cerebrovascular disease with sequelae, Parkinson's disease, schizophrenia).
- Active digestive bleeding. Before inclusion, there must have been a 48-hour period without signs of bleeding.
- Patients with hypersensitivity or allergy to any of the components of GELSECTAN® (grape, pea).
- Clinical situations in which the administration of oral feeding is contraindicated.
- Active oncological processes, including hepatocarcinoma.
- Active infection of any origin.
- Acute renal failure (AKI). Defined by the current diagnostic criteria of the KDIGO group (Kidney Disease Improving Global Outcomes).
- Dehydration Diagnosed by physical examination of the patient.
- Severe hyponatremia. Defined by plasma sodium \<130 mEq / dl.
- Concomitant use of sedative drugs, such as benzodiazepines, morphic or derivatives (methadone, tramadol ...)
- Active drug and/or alcohol use. In each case of clinical suspicion of drug use, an analysis of toxins in urine will be carried out, which includes cocaine, cannabis, opiates. All patients with confirmed alcohol consumption greater than 3 UBD in men or 2 UBD in women will be excluded.
- Consumption of drugs currently indicated for the treatment of HE: Lactulose, lactitol and antibiotics.
- Participation in another clinical trial
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05189834
Start Date
March 11 2022
End Date
July 30 2022
Last Update
February 28 2024
Active Locations (1)
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1
Consorci Sanitari Alt'Pènedes i Garraf
Barcelona, Catalonia, Spain, 08810