An observational study in Hepatic Encephalopathy and Acute-On-Chronic Liver Failure, sponsored by Medica Sur Clinic & Foundation. Status unknown at 1 site in Mexico. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-07.
Sponsored by Medica Sur Clinic & Foundation · Observational
Among 10 studies in Hepatic Encephalopathy with a site in Mexico — none open to participants now, none under way, none of them phase 3. Hepatic Encephalopathy · Mexico.
Among the 10 studies in Hepatic Encephalopathy with a site in Mexico, this one is the only one that started in 2022, is one of 4 observational ones, and was the 10th registered.
225 studies on the registry are indexed under Hepatic Encephalopathy; 53 are open to participants now.
Browse Hepatic Encephalopathy studies →None of the 10 studies in Hepatic Encephalopathy with a site in Mexico is open now. The open studies under Hepatic Encephalopathy, anywhere →
Of the 30 Hepatic Encephalopathy studies recruiting now, 12 (40%) set no upper age limit and 13 (43%) stop at 75 or younger; 1 takes children under 18; 3 take healthy volunteers.
This study: 20 Years to 70 Years · all sexes · healthy volunteers too.
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10 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2022.
This study's planned enrollment of 50 is below the median of 100 across 58 observational studies indexed under Hepatic Encephalopathy.
Median enrollment 35 across the 6 interventional studies, 70 across the 4 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
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None of the 10 has an industry lead sponsor. The 6 most frequent:
Medica Sur Clinic & Foundation is the lead sponsor of 2 studies on the registry; none are open to participants now.
Medica Sur Clinic & Foundation has 1 study filed under Hepatic Encephalopathy — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Hepatic Encephalopathy with a site in Mexico, from their registry updates:
Nothing recorded among them since 2026-09-25.
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It has been identified that impaired liver function, as occurs in patients with liver cirrhosis, prevents proper conjugation of glucuronic acid with bilirubin; as a result, unconjugated bilirubin accumulates in the blood, and conjugated bilirubin is markedly altered to form diglucuronides or monoglucuronides. However, in the development and progress of acute-on-chronic liver failure (ACLF) there is not enough information about these processes and the possible concentration levels that they can take.
Also Hepatic encephalopathy (HE) is a reversible complication, but with a high mortality rate in patients with acute or chronic liver failure, as well as a consequence of the formation of portosystemic shunts.
Liver cirrhosis is a pathological diagnosis characterized by diffuse fibrosis, severe alteration of intrahepatic arterial and venous flow, portal hypertension, and, ultimately, liver failure. The prevalence of liver cirrhosis in the Mexican population depends on various factors, including gender, ethnic groups, and geographic regions, in addition to the nature, frequency, and time of acquisition of the main risk factors for cirrhosis, such as the hepatitis B virus, hepatitis C virus (HCV) in addition to non-alcoholic steatohepatitis, non-alcoholic fatty liver or alcoholic liver disease. Liver cirrhosis has been classified as decompensated or compensated. Decompensated liver cirrhosis occurs when there is gradual progression over months causing liver and extrahepatic organ failure. On the other hand, if it appears suddenly, in a short-term deterioration for days or several weeks after the defined triggering disease, it is known as Acute-on-chronic liver failure (ACLF). ACLF is a syndrome characterized by acute and severe liver abnormalities as a result of different types of lesions present in patients with underlying chronic liver disease or cirrhosis, but unlike decompensated cirrhosis, it has a high short-term mortality.
It is important to determine the prognosis of patients with ACLF, in a short period of time, in order to act appropriately and reduce the use of temporary liver support or liver transplantation, an important variable that is included in various scores that assess liver function in different scenarios such as the Child-Pugh score and Model for End-stage Liver Disease (MELD) systems.
Among liver cirrhosis complications, there is the Hepatic encephalopathy (HE) involves a wide range of neurocognitive and psychiatric abnormalities that can range from subclinical neurological deficits and disturbances in attention to coma. Diagnosis of hepatic encephalopathy can be made using the West Haven (WH) criteria, which are clinical criteria that evaluate the degree of neurological deterioration and divide hepatic encephalopathy into 5 grades (from grade 0 to grade 4), with grades 3 and 4 having a worse prognosis. In addition to these criteria, it can be diagnose based on psychometric tests such as the Portosystemic- Encephalopathy- Syndrome test (PSE) and psychophysiological tests, such as the Critical flicker frequency (CFF). Despite the existence of this evidence and the WH criteria, there is no quantitative parameter that can be used to diagnose the hepatic encephalopathy. In addition, although the quantification of ammonia levels is carried out in multiple centers as part of the protocol for diagnosing HE, there are numerous studies showing that ammonia levels cannot be used to diagnose or rule out the presence of HE.
Patients admitted in emergency room or hospitalized for liver cirrhosis with development of ACLF and hepatic encephalopathy. Also patients with liver cirrhosis compensated and healthy people.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will include patients with diagnosed liver cirrhosis regardless of the cause hospitalized and/or presenting to the emergency department for possible ACLF. With any etiology of liver cirrhosis including alcoholic liver disease (ALD), chronic hepatitis C virus (HCV), metabolism associated fatty liver disease (MAFLD) and autoimmune liver diseases.
Diagnostic Test: Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular species
This group will include patients with diagnosed liver cirrhosis, any etiology of liver cirrhosis including alcoholic liver disease (ALD), chronic hepatitis C virus (HCV), metabolism associated fatty liver disease (MAFLD) and autoimmune liver diseases. No previous episodes of ACLF and at the time of admission.
Diagnostic Test: Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular species
People who do not have any acute or chronic degenerative disease. Participation on a voluntary basis.
Diagnostic Test: Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular species
This group will include patients with diagnosed liver cirrhosis who develop hepatic encephalopathy graded according to West Haven.
Diagnostic Test: Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular species
It will determine the concentration of the different molecular species of bilirubin and examine the pattern of increase present in patients with liver cirrhosis who develop hepatic encephalopathy and acute-on-chronic liver failure (ACLF) compared to other groups like patients with liver cirrhosis and healthy people.
Identify levels of Conjugated Bilirubin as Bilirubin monoglucuronide (BMG), bilirubin diglucuronide (BDG) and unconjugated bilirubin (UCB) in patients with acute-on-chronic liver failure
Identification and measured concentration of bilirubin molecular species through liquid chromatography-mass spectrometry (LC-MS)
Time frame: The serum sample will be taken at the moment of the first patient physician contact (admission, medical visit). The bilirubin measure will be done 24 hours after
Comparison of the bilirubin levels of the different groups
The results of the groups will be compared among them to evaluate whether or not there is a change in the concentration.
Time frame: It will be analyzed when all the results from the LC-MS are done. Approximately 5 months.
Plan to share: Undecided
Started Aug 2022 (actual). Primary completion is estimated for Jul 2023, 11 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Medica Sur Clinic & Foundation