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

7 giugno 2026 aggiornato da: Ayten Amr Abd El-monem, Beni-Suef University
This study aims to evaluate the possible efficacy of l-carnitine in critically ill hepatic patients admitted to intensive care unit.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

58

Fase

  • Fase 4

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: gruppo di controllo
Standard medical treatment for hepatic patient admitted to icu
Comparatore attivo: test group
l carnitine
Standard medical treatment for hepatic patient admitted to icu
L-Carnitine, a natural substance present in the body, is essential for energy metabolism in mammals. l-carnitine presents as a drug.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
laboratory value: serum creatinine(SCr)
Lasso di tempo: At ICU admission and at ICU discharge, an average of 7 days
At ICU admission and at ICU discharge, an average of 7 days
laboratory value: international normalized ratio
Lasso di tempo: At ICU admission and at ICU discharge, an average of 7 days
At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Blood urea nitrogen(BUN)
Lasso di tempo: At ICU admission and at ICU discharge, an average of 7 days
At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Albumin
Lasso di tempo: At ICU admission and at ICU discharge, an average of 7 days
At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Alanine aminotransferase(ALT)
Lasso di tempo: At ICU admission and at ICU discharge, an average of 7 days
At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Aspartate aminotransferase(AST)
Lasso di tempo: At ICU admission and at ICU discharge, an average of 7 days
At ICU admission and at ICU discharge, an average of 7 days

Altre misure di risultato

Misura del risultato
Lasso di tempo
• hospitalization stay in ICU
Lasso di tempo: At ICU admission and at ICU discharge, an average of 7 days
At ICU admission and at ICU discharge, an average of 7 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

2 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 00859/2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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