Hepatic EncephalopathyNCT05566548
Role of Bilirubin Molecular Species in Hepatic Encephalopathy and Acute-on-chronic Liver Failure
An observational study of Hepatic Encephalopathy and Acute-On-Chronic Liver Failure, run by Medica Sur Clinic & Foundation at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Encephalopathy, Acute-On-Chronic Liver Failure
- What is being tested?
- Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular species
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2022to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients with Acute-on-chronic liver failure (ACLF)
- Patients hepatic encephalopathy (HE)
- Any etiology of liver cirrhosis alcoholic liver disease (ALD), HCV, liver disease fatty liver associated with metabolism dysfunction (MAFLD) and diseases autoimmune liver
- With or without the existence of any precipitating event or medical complication: infection acute bacterial, consumption hepatitis severe alcoholic, variceal bleeding, drug-induced encephalopathy, ascites, coagulopathy, sepsis
- Any ACLF grade
- Any HE grade
Who cannot join
- Immunodeficiency virus infection human (HIV)
- Cholestatic liver disease,
- Past or current extrahepatic malignant tumor,
- Liver transplant,
- Other serious concomitant diseases heart, lung, kidney, or other organs
- Patients with metastatic hepatocellular carcinoma (HCC)
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Medica Sur Clinic & Foundation Organization
Mexico City, 14050
Nahum Mendez-Sanchez, MD, PhD, +52 5554335016, nmendez@medicasur.org.mx
Stephany M Castillo-Castañeda, Graduated, +52 2229650475, stephany_castillo@comunidad.unam.mx
About this study
Official title: The Importance of Bilirubin Molecular Species in Patients With Liver Cirrhosis Who Develop Hepatic Encephalopathy and Patients With Acute-on-chronic Liver Failure
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.
Read the detailed description
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.
- Being tested
- Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular species
- Keywords
- Bilirubin, Unconjugated bilirubin, Conjugated bilirubin, Bilirubin diglucuronide, Bilirubin monoglucuronide, ACLF, Encephalopathy
- Medical subject headings
- Hepatic Encephalopathy, Acute-On-Chronic Liver Failure, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular speciesDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group of patients with liver cirrhosis and ACLF | 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. Receives: Diagnostic Test: Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular species | |
| Group of patients with liver cirrhosis compensated | 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. Receives: Diagnostic Test: Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular species | |
| Group of healthy people | People who do not have any acute or chronic degenerative disease. Participation on a voluntary basis. Receives: Diagnostic Test: Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular species | |
| Group of patients with liver cirrhosis and hepatic encephalopathy | This group will include patients with diagnosed liver cirrhosis who develop hepatic encephalopathy graded according to West Haven. Receives: Diagnostic Test: Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular species |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Secondary outcomes (1)
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.
Measured: It will be analyzed when all the results from the LC-MS are done. Approximately 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Aug 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medica Sur Clinic & Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahum Méndez-Sánchez, Medica Sur Clinic & Foundation
- Investigators
- Nahum Mendez-Sanchez, MD, PhD, Study director, Medica Sur Clinic & Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566548
- Sponsor's protocol ID
- 2021-EXT-637
- Status last verified
- Oct 2022
- First submitted
- 30 Sep 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Karimzadeh P, Fallahi M, Kazemian M, Taslimi Taleghani N, Nouripour S, Radfar M. Bilirubin Induced Encephalopathy. Iran J Child Neurol. 2020 Winter;14(1):7-19.
PubMed 32021624Tapper EB, Rahimi RS. Low-Value Levels: Ammonia Testing Does Not Improve the Outcomes of Overt Hepatic Encephalopathy. Am J Gastroenterol. 2020 May;115(5):685-686. doi: 10.14309/ajg.0000000000000454.
PubMed 31714365Lopez-Velazquez JA, Chavez-Tapia NC, Ponciano-Rodriguez G, Sanchez-Valle V, Caldwell SH, Uribe M, Mendez-Sanchez N. Bilirubin alone as a biomarker for short-term mortality in acute-on-chronic liver failure: an important prognostic indicator. Ann Hepatol. 2013 Jan-2014 Feb;13(1):98-104.
PubMed 24378272Moreau R, Jalan R, Gines P, Pavesi M, Angeli P, Cordoba J, Durand F, Gustot T, Saliba F, Domenicali M, Gerbes A, Wendon J, Alessandria C, Laleman W, Zeuzem S, Trebicka J, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL-CLIF Consortium. Acute-on-chronic liver failure is a distinct syndrome that develops in patients with acute decompensation of cirrhosis. Gastroenterology. 2013 Jun;144(7):1426-37, 1437.e1-9. doi: 10.1053/j.gastro.2013.02.042. Epub 2013 Mar 6.
PubMed 23474284Lee HA, Jung JY, Lee YS, Jung YK, Kim JH, An H, Yim HJ, Jeen YT, Yeon JE, Byun KS, Um SH, Seo YS. Direct Bilirubin Is More Valuable than Total Bilirubin for Predicting Prognosis in Patients with Liver Cirrhosis. Gut Liver. 2021 Jul 15;15(4):599-605. doi: 10.5009/gnl20171.
PubMed 33293481Tang L, Zhang M, Li X, Zhang L. Glucuronidated bilirubin: Significantly increased in hepatic encephalopathy. Prog Mol Biol Transl Sci. 2019;162:363-376. doi: 10.1016/bs.pmbts.2018.12.009. Epub 2019 Mar 6.
PubMed 30905463Bajaj JS, O'Leary JG, Tandon P, Wong F, Garcia-Tsao G, Kamath PS, Maliakkal B, Biggins SW, Thuluvath PJ, Fallon MB, Subramanian RM, Vargas HE, Lai J, Thacker LR, Reddy KR. Hepatic Encephalopathy Is Associated With Mortality in Patients With Cirrhosis Independent of Other Extrahepatic Organ Failures. Clin Gastroenterol Hepatol. 2017 Apr;15(4):565-574.e4. doi: 10.1016/j.cgh.2016.09.157. Epub 2016 Oct 5.
PubMed 27720916
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Bilirubin Molecular Species in Patients With Liver Cirrhosis Who Develop Hepatic Encephalopathy and Patients With Acute-on-chronic Liver Failure
- ClinicalTrials.gov ID
- NCT05566548
- Acronym / sponsor ID
- 2021-EXT-637
- Keywords
- Bilirubin, Unconjugated bilirubin, Conjugated bilirubin, Bilirubin diglucuronide, Bilirubin monoglucuronide, ACLF, Encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medica Sur Clinic & FoundationUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group of patients with liver cirrhosis and ACLF | – | Diagnostic Test: Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular speciesThis 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. |
| Group of patients with liver cirrhosis compensated | – | Diagnostic Test: Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular speciesThis 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. |
| Group of healthy people | – | Diagnostic Test: Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular speciesPeople who do not have any acute or chronic degenerative disease. Participation on a voluntary basis. |
| Group of patients with liver cirrhosis and hepatic encephalopathy | – | Diagnostic Test: Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular speciesThis group will include patients with diagnosed liver cirrhosis who develop hepatic encephalopathy graded according to West Haven. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Patients with Acute-on-chronic liver failure (ACLF)
- Patients hepatic encephalopathy (HE)
- Any etiology of liver cirrhosis alcoholic liver disease (ALD), HCV, liver disease fatty liver associated with metabolism dysfunction (MAFLD) and diseases autoimmune liver
- With or without the existence of any precipitating event or medical complication: infection acute bacterial, consumption hepatitis severe alcoholic, variceal bleeding, drug-induced encephalopathy, ascites, coagulopathy, sepsis
- Any ACLF grade
Key exclusion criteria (6 listed)
- Immunodeficiency virus infection human (HIV)
- Cholestatic liver disease,
- Past or current extrahepatic malignant tumor,
- Liver transplant,
- Other serious concomitant diseases heart, lung, kidney, or other organs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid Chromatography-Mass Spectrometry Method to identify bilirubin molecular speciesIt 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. | Diagnostic test | Group of healthy people, Group of patients with liver cirrhosis and ACLF, Group of patients with liver cirrhosis and hepatic encephalopathy, Group of patients with liver cirrhosis compensated |
Primary outcome
Identify levels of Conjugated Bilirubin as Bilirubin monoglucuronide (BMG), bilirubin diglucuronide (BDG) and unconjugated bilirubin (UCB) in patients with acute-on-chronic liver failure
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
Identification and measured concentration of bilirubin molecular species through liquid chromatography-mass spectrometry (LC-MS)
1 secondary outcome
Comparison of the bilirubin levels of the different groups
Time frame: It will be analyzed when all the results from the LC-MS are done. Approximately 5 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Background: PubMed 32021624Karimzadeh P, Fallahi M, Kazemian M, Taslimi Taleghani N, Nouripour S, Radfar M. Bilirubin Induced Encephalopathy. Iran J Child Neurol. 2020 Winter;14(1):7-19.
- Background: PubMed 31714365Tapper EB, Rahimi RS. Low-Value Levels: Ammonia Testing Does Not Improve the Outcomes of Overt Hepatic Encephalopathy. Am J Gastroenterol. 2020 May;115(5):685-686. doi: 10.14309/ajg.0000000000000454.
- Results publication: PubMed 24378272Lopez-Velazquez JA, Chavez-Tapia NC, Ponciano-Rodriguez G, Sanchez-Valle V, Caldwell SH, Uribe M, Mendez-Sanchez N. Bilirubin alone as a biomarker for short-term mortality in acute-on-chronic liver failure: an important prognostic indicator. Ann Hepatol. 2013 Jan-2014 Feb;13(1):98-104.
- Results publication: PubMed 23474284Moreau R, Jalan R, Gines P, Pavesi M, Angeli P, Cordoba J, Durand F, Gustot T, Saliba F, Domenicali M, Gerbes A, Wendon J, Alessandria C, Laleman W, Zeuzem S, Trebicka J, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL-CLIF Consortium. Acute-on-chronic liver failure is a distinct syndrome that develops in patients with acute decompensation of cirrhosis. Gastroenterology. 2013 Jun;144(7):1426-37, 1437.e1-9. doi: 10.1053/j.gastro.2013.02.042. Epub 2013 Mar 6.
- Results publication: PubMed 33293481Lee HA, Jung JY, Lee YS, Jung YK, Kim JH, An H, Yim HJ, Jeen YT, Yeon JE, Byun KS, Um SH, Seo YS. Direct Bilirubin Is More Valuable than Total Bilirubin for Predicting Prognosis in Patients with Liver Cirrhosis. Gut Liver. 2021 Jul 15;15(4):599-605. doi: 10.5009/gnl20171.
- Results publication: PubMed 30905463Tang L, Zhang M, Li X, Zhang L. Glucuronidated bilirubin: Significantly increased in hepatic encephalopathy. Prog Mol Biol Transl Sci. 2019;162:363-376. doi: 10.1016/bs.pmbts.2018.12.009. Epub 2019 Mar 6.
- Results publication: PubMed 27720916Bajaj JS, O'Leary JG, Tandon P, Wong F, Garcia-Tsao G, Kamath PS, Maliakkal B, Biggins SW, Thuluvath PJ, Fallon MB, Subramanian RM, Vargas HE, Lai J, Thacker LR, Reddy KR. Hepatic Encephalopathy Is Associated With Mortality in Patients With Cirrhosis Independent of Other Extrahepatic Organ Failures. Clin Gastroenterol Hepatol. 2017 Apr;15(4):565-574.e4. doi: 10.1016/j.cgh.2016.09.157. Epub 2016 Oct 5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nahum Mendez-Sanchez, MD, PhD study director
Medica Sur Clinic & Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Encephalopathy and Acute-On-Chronic Liver Failure, run by Medica Sur Clinic & Foundation at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nahum Mendez-Sanchez, MD, PhD (+52 555 433 5016, nmendez@medicasur.org.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify levels of Conjugated Bilirubin as Bilirubin monoglucuronide (BMG), bilirubin diglucuronide (BDG) and unconjugated bilirubin (UCB) in patients with acute-on-chronic liver failure (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05566548, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.