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Showing 1-20 of 128 trials
NCT07465471
Acute variceal bleeding (AVB) in cirrhosis occurs as a result of portal hypertension and carries a 6-week mortality rate of approximately 10-20%. Standard management includes a restrictive transfusion approach, vasoactive therapy, prophylactic antibiotics, and endoscopic band ligation. Despite this, early rebleeding within the first 5 days still occurs in about 10-20% of patients, and individuals at particularly high risk may benefit from pre-emptive TIPS. However, its real-world use remains limited; one study reported that only 6.7% of eligible patients actually underwent pre-emptive TIPS, primarily due to logistical challenges and limited interventional radiology availability for early, non-emergent TIPS procedures. Midodrine, an oral and fast-acting selective α1-adrenergic agonist, has been shown to enhance the effectiveness of nonselective beta-blockers like propranolol by allowing higher tolerated doses and achieving greater reductions in portal pressure (HVPG), thereby reducing the risk of initial variceal bleeding. However, no studies have evaluated the combination of midodrine with carvedilol-currently a preferred agent-versus carvedilol alone in patients at high risk of rebleeding. To address this gap, we propose a study comparing carvedilol plus midodrine with carvedilol alone for preventing early rebleeding in cirrhotic patients. Individuals with cirrhosis (Child-Pugh 8-13) presenting with hematemesis will be enrolled, stabilized according to APASL guidelines, and after 48 hours randomized to either combined midodrine-carvedilol therapy or carvedilol alone. Participants will be followed for 6 weeks to assess the incidence of early rebleeding.
NCT07459972
This prospective open-label parallel pilot clinical study evaluated the efficacy and safety of physiologically based pharmacokinetic (PBPK)-guided simvastatin dosing in Child-Pugh A and B cirrhotic patients with portal hypertension over a 3-month period. Twenty-two patients were enrolled following screening, and portal hemodynamic, laboratory, and safety parameters were assessed.
NCT07433881
Hepatitis A virus (HAV) superinfection in patients with cirrhosis can precipitate acute hepatic decompensation and significantly worsen outcomes. Although HAV exposure was historically universal in India, recent evidence shows declining natural immunity in adults, particularly in urban populations. Contemporary data on HAV seroprevalence and vaccine immunogenicity in Indian cirrhotics remain scarce. Updated evidence is necessary to inform national vaccination policy for chronic liver disease. This study aims to estimate the prevalence of anti-HAV IgG among adults with cirrhosis and identify predictors of non-immunity. A secondary objective is to evaluate early immunogenicity and durability of a single dose of inactivated HAV vaccine in baseline non-immune patients. This study will generate updated sero-epidemiological data and prospective evidence on single-dose HAV vaccine immunogenicity in Indian cirrhotics, providing essential guidance for HAV vaccination policies in cirrhosis. STUDY DESIGN: Observational cross-sectional study with a nested prospective cohort.
NCT06749340
Reasons such as sleep disorders, depression, decreased independence in daily living activities and decreased quality of life, which are seen in the majority of liver cirrhosis patients, can cause cognitive dysfunction, especially attention. It is known that physical dysfunctions are observed in patients with liver cirrhosis along with cognitive dysfunction. Sarcopenia is the most important of these dysfunctions. Sarcopenia is the progressive, widespread loss of muscle mass, function and strength. The aim of this study is to determine the effects of face-to-face and home-based progressive strengthening exercise program performed 3 times a week for 12 weeks on muscle strength, muscle mass, functionality and cognitive functions in individuals with liver cirrhosis. It is also aimed to test the feasibility and effectiveness of the home-based exercise method in individuals with liver cirrhosis. Another aim of our study is to determine the exercise dose required to improve muscle strength, muscle mass, functionality and cognitive functions in individuals with liver cirrhosis and the duration of treatment effectiveness through follow-up.
NCT07374185
the study includes patients with liver cirrhosis irrespective of the stage excluding people with active tumor or other major health issue endangering life, the protocol includes the use of autologous bone marrow derived mononuclear cells harvested from the same patient under local anesthesia ,followed by cell concentration and viability testing , then final product is combined with small volume of 2 cc of Wharton gel exosomes 20 billion per to be administered intravenously.
NCT06169592
The aim of the study is to improve the results of related transplantation of the right liver lobe by verifying the general predictors of the development of hemostatic system disorders and optimizing a comprehensive program for thrombohemorrhagic complications preventing.
NCT05253287
Globally, cirrhosis and liver cancer carries a huge burden and accounts for about 3.5% (2 million) of all deaths every year. Once decompensated, i.e. development of ascites, variceal bleed, encephalopathy, and jaundice, the life expectancy is markedly reduced to a median of two years. The definitive treatment in this stage, i.e., liver transplantation is limited by cost, lack of donors, and life-long immunosuppression. In addition to complications due to portal hypertension and hepatic insufficiency, decompensated cirrhosis is associated with malnutrition, sarcopenia, immune dysfunction, and impaired regeneration. Patients with cirrhosis are growth hormone (GH) resistant, with reduced insulin-like growth factor, which are linked to malnutrition and poor liver regeneration in cirrhosis. Diverse preclinical and clinical investigations in vitro and in vivo, have shown a benefit of GH in GH deficient, elderly and HIV positive patients. GH therapy in cirrhosis has been shown to improve nitrogen economy and to improve the GH resistance in a small pilot study by Donaghy et al. Also, GH therapy of short duration has shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis. GH therapy has also been shown to improve liver regeneration and protein synthesis after hepatectomy in patients of HCC with cirrhosis. However, there is a scarcity of data on clinical impact of long term administration of GH therapy in patients of cirrhosis. Hence, we undertook the present study to study the effect of growth hormone on clinical outcomes, malnutrition, immune cells and liver regeneration in patients with cirrhosis.
NCT07275554
This study aims to investigate the methylomic features of patients with hepatitis B-related acute-on-chronic liver failure and establish and validate a prognostic risk prediction classification model. The findings are of significant importance for guiding clinical practice and improving patient prognosis. Additionally, a methylomics-based classifier model for liver failure will be developed for disease prognosis analysis and clinical assessment, with the potential to enhance the diagnostic efficiency of liver failure.
NCT07252401
Acute gastrointestinal bleeding (AGIB) is a common complication in the decompensated stage of liver cirrhosis, of which approximately 70% is acute variceal bleeding (AVB) caused by portal hypertension. Existing evidence suggests that both terlipressin and somatostatin can be used to control AVB in cirrhotic patients, but terlipressin may be the first-line treatment for cirrhotic patients with AGIB complicated by acute kidney injury (AKI). Herein, a multicenter randomized controlled trial (RCT) has been designed to compare the efficacy of terlipressin and somatostatin in the treatment of cirrhotic patients with AGIB complicated by AKI.
NCT07183293
This study is a multicenter, randomized, prospective trial designed to evaluate the efficacy and safety of pegylated interferon α-2b (Peg-IFN-α2b) combined with nucleos(t)ide analogues (NAs) versus NAs monotherapy in patients with compensated hepatitis B cirrhosis. A total of 30 patients with compensated HBV-related cirrhosis will be enrolled and randomized in a 2:1 ratio to either Experimental Group 1 (n=20) or Experimental Group 2 (n=10). The treatment regimens consist of Peg-IFN-α2b combined with NAs (ETV/TAF/TMF/TDF) or NAs (ETV/TAF/TMF/TDF) monotherapy.
NCT07162636
Introduction: Sarcopenia, whether primary or secondary, substantially impacts the quality of life of patients post-hospital discharge. Compromised functional capacity can lead to a high prevalence of readmissions. In this context, neuromuscular electrical stimulation (NMES), when combined with voluntary contraction (NMES+), emerges as a promising strategy for optimizing muscle strength gain. Objective: To evaluate the efficacy of NMES+ in improving lower limb muscle strength and physical performance in hospitalized sarcopenic individuals with alcoholic cirrhosis. Methods: This is a double-blind, randomized clinical trial. The Intervention Group will undergo NMES+, while the Control Group will perform resistance exercises. The sample will consist of individuals aged 47 to 70 years, diagnosed with sarcopenia through functional tests: handgrip strength and the 5-repetition sit-to-stand test. The protocol will be applied six times per week. Assessments will be conducted at hospital admission and discharge. Data will be analyzed using Student's T-tests for intergroup and intragroup comparisons; Spearman's or Pearson's correlation will assess the association between hospital readmission rates and physical function at hospital discharge. A p-value of 0.05 was set as statistically significant. Expected Results: To observe a statistically significant increase in muscle strength and physical performance in the Intervention Group, and to find a negative correlation between improved physical function and hospital readmission rates. Conclusion: This study is expected to contribute to more effective rehabilitation protocols, improving functionality and reducing hospital readmission in hospitalized patients with alcoholic liver cirrhosis.
NCT07129447
The goal of this observational study is to learn about the feasibility and safety evaluation of endoscopic treatment of esophagogastric varices in cirrhosis on the day-care ward. The main question it aims to answer is: Is inpatient endoscopic treatment on day wards also feasible and safe for patients with esophagogastric variceal bleeding in cirrhosis when compared to inpatient endoscopy on a general ward? Participants undergoing inpatient endoscopic treatment for cirrhotic esophagogastric variceal bleeding on day wards and general wards will answer online survey questions about their postoperative period over a 1-year period.
NCT05516498
This is a two part Phase IIa/b multicentre, randomised, double-blind, placebo-controlled, parallel group dose-ranging study to assess the efficacy, safety, and tolerability of the combination of zibotentan and dapagliflozin, and dapagliflozin monotherapy versus placebo in participants with cirrhosis with features of portal hypertension.
NCT06855056
The study aims to test the effectiveness of new biomarkers (measurable molecules in our body) in predicting the health outcome of patients with liver cirrhosis discharged from the hospital after a serious complication of the disease
NCT07002827
Exogenous growth factor-mobilized bone marrow (BM) stem cells(G-CSF) and DARBEPOETIN use have shown a differential response in the management of decompensated cirrhosis (DC) with improved survival, CTP and MELD scores. This study was designed to evaluate potential clinical benefit of repeated cycles of granulocyte-colony stimulating factor (G-CSF) and DARBEPOETIN versus single cycle on delta change in immunometabolic profile of patients at 6 months assessed in terms of -Change in innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation .
NCT06312826
Hepatocellular carcinoma (HCC) is the third most frequent cause of cancer-related deaths worldwide. The incidence of HCC has been rapidly rising worldwide over the last two decades. In order to improve survival with curative treatment, regular surveillance to detect early-stage HCC is recommended for at-risk populations. Although ultrasonography (US) has been endorsed as the primary surveillance tool for HCC, a recent meta-analysis found that US has a sensitivity of 47% for detecting early-stage HCC, and its sensitivity for detecting early-stage HCC has been questioned. Many recent studies have explored the potential of alternative surveillance tools for HCC other than US, particularly for high-risk patients. Although complete gadoxetic acid-enhanced magnetic resonance imaging (MRI) demonstrated excellent performance, its high cost and long examination time can hamper its widespread adoption. Abbreviated MRI (AMRI) including hepatobiliary-phase imaging is a promising option to detect potential indicators of HCC, maintaining the benefits of highly sensitive imaging while reducing the examination time by omitting dynamic contrast-enhanced imaging. Because US is the current primary surveillance tool for HCC, this new surveillance tool must be compared with US in a prospective randomized comparative design. Thus, the hypothesis to be proved in this study is as follows: AMRI with gadoxetic acid will show a significantly higher detection rate compared to US for the detection of early-stage HCC in patients with cirrhosis and at high risk of developing HCC, defined as an estimated annual HCC risk of higher than 5%. We will also analyze whether the false-referral rate of AMRI with gadoxetic acid is not compromised by its high detection rate.
NCT04448028
Proton-pump inhibitors (PPI) are commonly prescribed in an uncritical manner to patients with liver cirrhosis without a clear evidence-based indication. Observational studies suggests that PPI use in cirrhotic patients may be a risk factor for the development of infections, especially spontaneous bacterial peritonitis (SBP). A possible explanation are PPI-associated microbiotic shifts leading to small intestinal bacterial overgrowth with subsequently increased bacterial translocation. Furthermore, PPI therapy in cirrhotic patients may lead to an increased risk for pneumonia and Clostridium difficile-infections. However, the evidence is ambiguous, as other published studies found no evidence for an association of PPI use with an increased risk for SBP or pneumonia. Moreover, an association between episodes of hepatic encephalopathy and PPI use has been reported. Infections and hepatic encephalopathy may often lead to a hospitalization of cirrhotic patients and PPI use at discharge has also been associated to early re-hospitalization. While some studies found an association of PPI and increased mortality in cirrhotic patients, other studies could not observe this association. Thus, some of the current evidence suggests an unfavourable risk profile of PPIs in patients with liver cirrhosis. However, this patient population is considered to be at a high risk of gastrointestinal haemorrhage from peptic ulcers. Importantly, patients with liver cirrhosis have an increased mortality after peptic ulcer bleeding as compared to patients without cirrhosis. Therefore, generous PPI use may also have a yet unproven preventive effect against upper gastrointestinal bleeding. The STOPPIT trial is the first prospective, randomized, controlled, double-blind trial investigating the effect of discontinuation of long-term PPI therapy on hospitalized patients with complicated liver cirrhosis with a pre-existing long-term PPI therapy. Importantly, patients with an evidence-based indication for PPI therapy are excluded from the trial. All study participants (n=476) stop their previous PPI treatment and are then randomized (1:1) to receive either placebo (intervention group) or esomeprazole 20mg/day (control group) for 360 days. The primary hypothesis anticipates a delay of re-hospitalisation and/or death (composite endpoint) in patients who discontinue PPI treatment as compared to patients who continue PPI therapy. Secondary objectives include the assessment of mortality, re-hospitalisation rates, infection rates, rate of acute hepatic decompensation and ACLF, as well as rates of upper and lower gastrointestinal bleeding events in both groups. Impact of prolonged or discontinued PPI therapy on the intestinal microbiota and pharmacoeconomics will be studied as a secondary assessment.
NCT05869591
The goal of this clinical trial is to investigate pharmacokinetics and pharmacodynamics of direct oral anticoagulant drugs (DOAC), specifically apixaban and edoxaban, in patients with Child A or B liver cirrhosis (LC). The primary objective of this study is to verify the ability of apixaban and edoxaban to decrease in vivo thrombin generation in LC patients. Participants will be randomly assigned to either apixaban (Eliquis®) or edoxaban (Lixiana®) at a therapeutic dosage for 7 consecutive days. The results of this investigation will contribute to designing a prospective multicentre interventional study to investigate the efficacy of DOAC to improve clinical outcomes in patients with LC
NCT06814626
The hypothesis is that in patients with cirrhosis and refractory ascites candidate to TIPS, and sarcopenia (identified by a PMA ≤16 cm² at the level of L3), who are at high-risk of 6-month mortality after TIPS placement, a post-TIPS 12 weeks nutritional intervention is associated with improved post-TIPS prognosis. The primary objective is to evaluate the effect of a post-TIPS 12 weeks nutritional intervention on liver transplant-free six-month survival in sarcopenic candidates to TIPS for refractory ascites in cirrhosis.
NCT06809088
Acute kidney injury accompanies about 20% of hospitalized patients with cirrhosis and in about 40% of those admitted to ICU.A critically ill patient with cirrhosis refers to an individual who has advanced liver disease (cirrhosis) and is experiencing severe and potentially life-threatening complications that require intensive medical care and monitoring. These complications might include hepatic encephalopathy, acute liver failure, severe bleeding due to portal hypertension, or other organ failures. Such patients often require specialized medical attention and interventions to stabilize their condition. The short-term prognosis of cirrhotic patients with acute kidney injury is poor, with a mortality rate higher than 65% in patients with RRT requirement. Patients with cirrhosis are prone to develop AKI . HRS comprises specific form of AKI\[HRS-AKI\] in patients with advanced cirrhosis and ascites, carries a high mortality risk. Role of albumin as colloid serves both as volume supplement and also as additive to vasoconstrictors. Ascites, elevated bilirubin, spontaneous bacterial peritonitis \[SBP\] and use of amino glycosides antibiotics had previously been identified as significant risk factors for renal failure in cirrhotic patients. The causes of AKI in cirrhotic patients include HRS \[most common\], others include ATN \[associated mostly with sepsis\]and hypovolemic shock. Three month survival ranged from 73% in patients with parenchymatous AKI to 15% for HRS. As per 2023 joint meeting of ICA and ADQI ,based on baseline serum creatinine\[sCr\](a lowest value obtained within the previous 3 months),AKI is defined by an absolute increases of sCr\>=0.3mg/dl within 48hr or a percentage increase of sCr\>=50% from baseline within 7 days and urine output \<= 0.5ml/kg for \>=6hrs.As per KDIGO ,three stages of AKI are defined :Stage 1\]when the previous criteria are met \[a relative increase of sCr 1.5-2.0from baseline, stage 2\]when increase in sCr is \>2folds to 3 folds from baseline and Stage 3\]when there is an increase of sCr\>3 folds from baseline or sCr is \>4.0mg/dl with an acute increase of \>0.3mg/dl or initiation of RRT. So, the study aims to analyze the role of albumin as a volume supplement and as a vasoconstrictor as well as its immunomodulatory effect in sepsis to help in resolution of AKI.Here we compare the effectiveness of personalized-dose albumin administration with fixed-dose albumin for treating acute kidney injury in patients with cirrhosis and sepsis associated AKI.