HepaticPhase 4NCT07642076
Evaluation of the Clinical Impact of Adjunctive L-carnitine Therapy in Critically Ill Hepatic Patients Admitted to Intensive Care Unit
A Phase 4 study testing L Carnitine and Standard medical treatment in people with Hepatic, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This study aims to evaluate the possible efficacy of l-carnitine in critically ill hepatic patients admitted to intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic
- What is being tested?
- L Carnitine and Standard medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2026to Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years old
- male or female with confirmed liver disease admitted to intensive care unit, including:
- Acute-on-chronic liver failure (ACLF)
- Hepatic encephalopathy
- spontaneous bacterial peritonitis (SBP)
- variceal bleeding
Show all 10Show fewer
- fulminant hepatitis
- Hepatorenal syndrome
- Ascites
- Etc
Who cannot join
- Age of less than 18 years old
- Pregnancy or Lactation
- patients have seizure
- patient on warfarin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National liver institute
Shibīn al Kawm
Ayten A Abd El-monem, 01099850069, aytenamr2023@gmail.com
About this study
This study aims to evaluate the possible efficacy of l-carnitine in critically ill hepatic patients admitted to intensive care unit.
Read the detailed description
Decompensated cirrhosis is characterized by high hospitalization rates and costs, frequent readmissions, and poor short-term survival. Patients admitted to the hospital with acute variceal bleeding and/or hepatic encephalopathy are at serious risk for developing infection and/or sepsis; in turn, this renders them highly susceptible to the development of multi-system organ failure. The lack of standardized intensive care unit management protocols in patients with cirrhosis along with only few data reports from longitudinal clinical trials makes it difficult for hepatologists and critical care specialists to provide uniform evidence for clinical practice that could safely consolidate favorable outcomes such as lower hospitalization rates and/or mortality.
Decompensated cirrhosis is a common reason for admission to the acute medical unit, and such patients typically have complex medical needs and are at high risk of in-hospital death. It is therefore vital that these patients receive appropriate investigations and management as early as possible in their patient journey. Typical presenting clinical features include jaundice, ascites, hepatic encephalopathy, hepato-renal syndrome ,or variceal hemorrhages.
hepatic encephalopathy (HE) is defined as a brain dysfunction caused by liver insufficiency and/or portal-systemic blood shunting. It manifests as a wide spectrum of neurological or psychiatric abnormalities, ranging from subclinical alterations, detectable only by neuropsychological or neurophysiological assessment, to coma.
Hepatorenal syndrome (HRS) is a common complication of advanced cirrhosis, characterized by renal failure and major disturbances in circulatory function. Renal failure is caused by intense vasoconstriction of the renal circulation. The syndrome is probably the final consequence of extreme underfilling of the arterial circulation secondary to arterial vasodilatation in the splanchnic vascular bed. As well as the renal circulation, most extra splanchnic vascular beds are vasoconstricted.
Spontaneous bacterial peritonitis (SBP) is the most frequent and life-threatening infection in patients with liver cirrhosis requiring prompt recognition and treatment. It is defined by the presence of >250 polymorphonuclear cells (PMN)/mm3 in ascites in the absence of an intra-abdominal source of infection or malignancy.
Fulminant hepatic failure is characterized by the development of severe liver injury with impaired synthetic capacity and encephalopathy in patients with previous normal liver or at least well compensated liver disease. The etiology of fulminant hepatic failure refers to a wide variety of causes, of which toxin-induced or viral hepatitis are most common.
Acute-on-chronic liver failure combines an acute deterioration in liver function in an individual with pre-existing chronic liver disease and hepatic and extrahepatic organ failures, and is associated with substantial short-term mortality. Common precipitants include bacterial and viral infections, alcoholic hepatitis, and surgery, but in more than 40% of patients, no precipitating event is identified. Systemic inflammation and susceptibility to infection are characteristic pathophysiological features.
Advanced cirrhosis can cause significant portal hypertension (PH), which is responsible for many of the complications observed in patients with cirrhosis, such as varices. If portal pressure exceeds a certain threshold, the patient is at risk of developing life-threatening bleeding from varices.
Ascites is the pathological state in which fluid accumulates in the peritoneal cavity. Fluid accumulation may be due to infection and malignancy or due to other diseases like liver disease, heart failure, and renal disease. The prominent cause of ascites is found to be Liver Cirrhosis. The most common symptom of Ascites is recent weight gain, increased abdominal girth and dyspnea. The first line treatment of ascites includes education regarding dietary sodium restriction and oral diuretics.
L-Carnitine, a natural substance present in the body, is essential for energy metabolism in mammals. Depending on the previous studies, l-Carnitine supplementation in critically ill patients can improve several parameters including International normalized ratio (INR), Creatinine(Cr), Alanine transferase (ALT), lactate, Calcium, Albumin, and total protein. Furthermore ,l-Carnitine supplementation significantly reduced the levels of CRP and IL-6.The Sequential Organ Failure Assessment (SOFA) Score and The Acute Physiology and Chronic Health Evaluation (APACHE II) score were reduced in the l-Carnitine group. In addition to, systematic review and meta-analysis revealed that L-carnitine supplementation significantly reduced blood levels of ammonia, bilirubin, Aspartate transferase(AST), Blood urea nitrogen (BUN), and Cr in HE patients. Moreover, L-carnitine increased circulating levels of albumin.
- Conditions
- Hepatic
- Being tested
- L Carnitine, Standard medical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L CarnitineDrug
L-Carnitine, a natural substance present in the body, is essential for energy metabolism in mammals. l-carnitine presents as a drug.
Standard medical treatmentDrug
Standard medical treatment for hepatic patient admitted to icu
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Not described Receives: Drug: Standard medical treatment |
| test group | Active comparator | l carnitine Receives: Drug: L Carnitine; Drug: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
laboratory value: serum creatinine(SCr)
Measured: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: international normalized ratio
Measured: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Blood urea nitrogen(BUN)
Measured: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Albumin
Measured: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Alanine aminotransferase(ALT)
Measured: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Aspartate aminotransferase(AST)
Measured: At ICU admission and at ICU discharge, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start15 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepaticStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayten Amr Abd El-monem, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642076
- Sponsor's protocol ID
- 00859/2026
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Impact of Adjunctive L-carnitine Therapy in Critically Ill Hepatic Patients Admitted to Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07642076
- Acronym / sponsor ID
- 00859/2026
- Conditions
- Hepatic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 11 Jun 2026 (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.
This study aims to evaluate the possible efficacy of l-carnitine in critically ill hepatic patients admitted to intensive care unit.
Detailed description
Decompensated cirrhosis is characterized by high hospitalization rates and costs, frequent readmissions, and poor short-term survival. Patients admitted to the hospital with acute variceal bleeding and/or hepatic encephalopathy are at serious risk for developing infection and/or sepsis; in turn, this renders them highly susceptible to the development of multi-system organ failure. The lack of standardized intensive care unit management protocols in patients with cirrhosis along with only few data reports from longitudinal clinical trials makes it difficult for hepatologists and critical care specialists to provide uniform evidence for clinical practice that could safely consolidate favorable outcomes such as lower hospitalization rates and/or mortality.
Decompensated cirrhosis is a common reason for admission to the acute medical unit, and such patients typically have complex medical needs and are at high risk of in-hospital death. It is therefore vital that these patients receive appropriate investigations and management as early as possible in their patient journey. Typical presenting clinical features include jaundice, ascites, hepatic encephalopathy, hepato-renal syndrome ,or variceal hemorrhages.
hepatic encephalopathy (HE) is defined as a brain dysfunction caused by liver insufficiency and/or portal-systemic blood shunting. It manifests as a wide spectrum of neurological or psychiatric abnormalities, ranging from subclinical alterations, detectable only by neuropsychological or neurophysiological assessment, to coma.
Hepatorenal syndrome (HRS) is a common complication of advanced cirrhosis, characterized by renal failure and major disturbances in circulatory function. Renal failure is caused by intense vasoconstriction of the renal circulation. The syndrome is probably the final consequence of extreme underfilling of the arterial circulation secondary to arterial vasodilatation in the splanchnic vascular bed. As well as the renal circulation, most extra splanchnic vascular beds are vasoconstricted.
Spontaneous bacterial peritonitis (SBP) is the most frequent and life-threatening infection in patients with liver cirrhosis requiring prompt recognition and treatment. It is defined by the presence of >250 polymorphonuclear cells (PMN)/mm3 in ascites in the absence of an intra-abdominal source of infection or malignancy.
Fulminant hepatic failure is characterized by the development of severe liver injury with impaired synthetic capacity and encephalopathy in patients with previous normal liver or at least well compensated liver disease. The etiology of fulminant hepatic failure refers to a wide variety of causes, of which toxin-induced or viral hepatitis are most common.
Acute-on-chronic liver failure combines an acute deterioration in liver function in an individual with pre-existing chronic liver disease and hepatic and extrahepatic organ failures, and is associated with substantial short-term mortality. Common precipitants include bacterial and viral infections, alcoholic hepatitis, and surgery, but in more than 40% of patients, no precipitating event is identified. Systemic inflammation and susceptibility to infection are characteristic pathophysiological features.
Advanced cirrhosis can cause significant portal hypertension (PH), which is responsible for many of the complications observed in patients with cirrhosis, such as varices. If portal pressure exceeds a certain threshold, the patient is at risk of developing life-threatening bleeding from varices.
Ascites is the pathological state in which fluid accumulates in the peritoneal cavity. Fluid accumulation may be due to infection and malignancy or due to other diseases like liver disease, heart failure, and renal disease. The prominent cause of ascites is found to be Liver Cirrhosis. The most common symptom of Ascites is recent weight gain, increased abdominal girth and dyspnea. The first line treatment of ascites includes education regarding dietary sodium restriction and oral diuretics.
L-Carnitine, a natural substance present in the body, is essential for energy metabolism in mammals. Depending on the previous studies, l-Carnitine supplementation in critically ill patients can improve several parameters including International normalized ratio (INR), Creatinine(Cr), Alanine transferase (ALT), lactate, Calcium, Albumin, and total protein. Furthermore ,l-Carnitine supplementation significantly reduced the levels of CRP and IL-6.The Sequential Organ Failure Assessment (SOFA) Score and The Acute Physiology and Chronic Health Evaluation (APACHE II) score were reduced in the l-Carnitine group. In addition to, systematic review and meta-analysis revealed that L-carnitine supplementation significantly reduced blood levels of ammonia, bilirubin, Aspartate transferase(AST), Blood urea nitrogen (BUN), and Cr in HE patients. Moreover, L-carnitine increased circulating levels of albumin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Standard medical treatment |
| test group | Active comparator | Drug: L Carnitine, Drug: Standard medical treatmentl carnitine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age more than 18 years old
- male or female with confirmed liver disease admitted to intensive care unit, including:
- Acute-on-chronic liver failure (ACLF)
- Hepatic encephalopathy
- spontaneous bacterial peritonitis (SBP)
Key exclusion criteria (4 listed)
- Age of less than 18 years old
- Pregnancy or Lactation
- patients have seizure
- patient on warfarin
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 |
|---|---|---|
| L CarnitineL-Carnitine, a natural substance present in the body, is essential for energy metabolism in mammals. l-carnitine presents as a drug. | Drug | test group |
| Standard medical treatmentStandard medical treatment for hepatic patient admitted to icu | Drug | control group, test group |
Primary outcome
laboratory value: serum creatinine(SCr)
Time frame: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: international normalized ratio
Time frame: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Blood urea nitrogen(BUN)
Time frame: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Albumin
Time frame: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Alanine aminotransferase(ALT)
Time frame: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Aspartate aminotransferase(AST)
Time frame: At ICU admission and at ICU discharge, an average of 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing L Carnitine and Standard medical treatment in people with Hepatic, run by Beni-Suef University at 1 site in Egypt.
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 10 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
laboratory value: serum creatinine(SCr) (time frame: At ICU admission and at ICU discharge, an average of 7 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026.