Evaluation of the Clinical Impact of Adjunctive L-carnitine Therapy in Critically Ill Hepatic Patients Admitted to Intensive Care Unit

This study aims to evaluate the possible efficacy of l-carnitine in critically ill hepatic patients admitted to intensive care unit.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatic
• Intervention / Treatment: Drug: Standard medical treatment; Drug: L Carnitine

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 Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• fulminant hepatitis
• Hepatorenal syndrome
• Ascites
• Etc

Exclusion Criteria:

• Age of less than 18 years old
• Pregnancy or Lactation
• patients have seizure
• patient on warfarin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Drug: Standard medical treatment; Standard medical treatment for hepatic patient admitted to icu
Active Comparator: test group; l carnitine	Drug: Standard medical treatment; Standard medical treatment for hepatic patient admitted to icu; Drug: L Carnitine; L-Carnitine, a natural substance present in the body, is essential for energy metabolism in mammals. l-carnitine presents as a drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
laboratory value: serum creatinine(SCr)	At ICU admission and at ICU discharge, an average of 7 days
laboratory value: international normalized ratio	At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Blood urea nitrogen(BUN)	At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Albumin	At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Alanine aminotransferase(ALT)	At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Aspartate aminotransferase(AST)	At ICU admission and at ICU discharge, an average of 7 days

Other Outcome Measures

Outcome Measure	Time Frame
• hospitalization stay in ICU	At ICU admission and at ICU discharge, an average of 7 days

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Amines; Quaternary Ammonium Compounds; Trimethyl Ammonium Compounds; Carnitine
• Other Study ID Numbers: 00859/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No