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Background Transjugular intrahepatic portosystemic shunt (TIPS) has recently been reported to be effective in the treatment of cirrhotic patients with refractory ascites. However, the clinical utility of TIPS in the subset of refractory ascitic patients with good hepatic and renal function is uncertain. The aim of this study was to compare the efficacy of TIPS to that of large-volume paracentesis in cirrhotic patients with refractory ascites who have good hepatic and renal function. Methods Sixty cirrhotic patients with refractory ascites who presented with a Child-Pugh score of <11, serum bilirubin of <3 mg/dl and creatinine of <1.9 mg/dl were assigned randomly to TIPS (n = 30) or large-volume paracentesis plus albumin (n = 30). The primary endpoint was survival. The secondary endpoints were response to treatment and development of hepatic encephalopathy. Results The baseline characteristics were similar in the two groups. Seventeen patients treated with TIPS and 21 treated with paracentesis died during the study period. The cumulative probabilities of survival at 1 and 2 years were 80 and 64% in the TIPS group and 49 and 35% in the paracentesis group (p < 0.005). TIPS was significantly superior to paracentesis in the control of ascites (p < 0.005). Treatment failure was more frequent in the paracentesis group, whereas the frequency of hepatic encephalopathy was greater in the TIPS group. Conclusions In cirrhotic patients with refractory ascites who have good hepatic and renal function, TIPS improves survival and provides better control of ascites than large-volume paracentesis.

BackgroundThe role of nonselective beta-blockers in cirrhotic patients with ascites has been recently questioned; however, definitive evidence in this regard is still lacking.AimsTo analyze published data on the influence of nonselective beta-blockers as compared to control group on survival of cirrhotic patients with ascites.MethodsComputerized bibliographic search on the main databases was performed. Hazard ratios from Kaplan–Meier curves were extracted in order to perform an unbiased comparison of survival estimates. Secondary outcomes were mortality in patients with refractory ascites, pooled rate of nonselective beta-blockers interruption, spontaneous bacterial peritonitis and hepato-renal syndrome incidence.ResultsThree randomized controlled trials and 13 observational studies with 8279 patients were included. Overall survival was comparable between the two groups (hazard ratio = 0.86, 0.71–1.03, p = 0.11). Study design resulted as the main source of heterogeneity in sensitivity analysis and meta-regression. Mortality in refractory ascites patients was similar in the two groups (odds ratio = 0.90, 0.45–1.79; p = 0.76). No difference in spontaneous bacterial peritonitis (odds ratio = 0.78, 0.47–1.29, p = 0.33) and hepato-renal syndrome incidence (odds ratio = 1.22, 0.48–3.09; p = 0.67) was observed. Pooled rate of nonselective beta-blockers interruption was 18.6% (5.2–32.1%).ConclusionsBased on our findings, nonselective beta-blockers should not be routinely withheld in patients with cirrhosis and ascites, even if refractory.

This study compared three methods of assessing malnutrition in cirrhotics and correlated nutritional status with clinical outcome. This cross-sectional study evaluated nutritional status by subjective global assessment (SGA), prognostic nutritional index (PNI), and handgrip strength (HG) in outpatients with cirrhosis (n = 50) and two control groups with hypertension (n = 46) and functional gastrointestinal disorders (n = 49). Patients with cirrhosis were followed for 1 y to verify the incidence of major complications, the need for transplantation, and death. Among patients with cirrhosis, 88% were Child-Pugh A and only 12% were Child-Pugh B. Among these, prevalences of malnutrition were 28% by SGA, 18.7% by PNI, and 63% by HG ( P < 0.05). HG, but not SGA or PNI, predicted a poorer clinical outcome in patients with cirrhosis because major complications such as uncontrolled ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, and hepatorenal syndrome developed in 65.5% of malnourished patients versus 11.8% of well-nourished ones ( P < 0.05). No significant differences by any method were seen between the two groups regarding liver transplantation or death. There was a high prevalence of malnutrition in cirrhotic outpatients, especially when assessed by HG, which was superior to SGA and PNI in this study. HG was the only technique that predicted a significant incidence of major complications in 1 y in undernourished cirrhotic patients.

Refractory or recurrent ascites is a clinical challenge frequently encountered in patients with cirrhosis. 1 – 3 The treatment options are repeated large-volume paracentesis, creation of a peritoneovenous shunt, creation of a portosystemic shunt, and liver transplantation. Elevated portal-vein pressure is a main factor in the pathogenesis of ascites. A reduction in pressure by means of the surgical creation of a portosystemic shunt 4 – 6 or transjugular intrahepatic portosystemic shunt 7 – 15 has been shown to be followed by decreased formation of ascites. With the exception of a small, randomized study 16 that found an increased rate of death among patients with ascites who were . . .

This two-arm, randomised, multicentre, open-label, phase IIIb study investigated the safety and efficacy of a 3-h catumaxomab infusion with/without prednisolone premedication to reduce catumaxomab-related adverse events. Patients with malignant ascites due to epithelial cancer received four 3-h intraperitoneal catumaxomab infusions with/without intravenous prednisolone (25 mg) premedication before each infusion. The primary safety endpoint was a composite safety score calculated from the incidence and intensity of the most frequent catumaxomab-related adverse events (pyrexia, nausea, vomiting and abdominal pain). Puncture-free survival (PuFS) was a co-primary endpoint. Time to next puncture (TTPu) and overall survival (OS) were secondary endpoints. Prednisolone premedication did not result in a significant reduction in the main catumaxomab-related adverse events. The mean composite safety score was comparable in both arms (catumaxomab plus prednisolone, 4.1; catumaxomab, 3.8; p  = 0.383). Median PuFS (30 vs. 37 days) and TTPu (78 vs. 102 days) were shorter in the catumaxomab plus prednisolone arm than in the catumaxomab arm, but the differences were not statistically significant ( p  = 0.402 and 0.599, respectively). Median OS was longer in the catumaxomab plus prednisolone arm than in the catumaxomab arm (124 vs. 86 days), but the difference was not statistically significant ( p  = 0.186). The superiority of catumaxomab plus prednisolone versus catumaxomab alone could not be proven for the primary endpoint. Prednisolone did not result in a significant reduction in the main catumaxomab-related adverse events. The study confirms the safety and efficacy of catumaxomab administered as four 3-h intraperitoneal infusions for the treatment of malignant ascites.

Background Patients with liver cirrhosis have a highly elevated risk of developing bacterial infections that significantly decrease survival rates. One of the most relevant infections is spontaneous bacterial peritonitis (SBP). Recently, NOD2 germline variants were found to be potential predictors of the development of infectious complications and mortality in patients with cirrhosis. The aim of the I N CA (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites) trial is to investigate whether survival of this genetically defined high-risk group of patients with cirrhosis defined by the presence of NOD2 variants is improved by primary antibiotic prophylaxis of SBP. Methods/Design The I N CA trial is a double-blind, placebo-controlled clinical trial with two parallel treatment arms (arm 1: norfloxacin 400 mg once daily; arm 2: placebo once daily; 12-month treatment and observational period). Balanced randomization of 186 eligible patients with stratification for the protein content of the ascites (<15 versus ≥15 g/L) and the study site is planned. In this multicenter national study, patients are recruited in at least 13 centers throughout Germany. The key inclusion criterion is the presence of a NOD2 risk variant in patients with decompensated liver cirrhosis. The most important exclusion criteria are current SBP or previous history of SBP and any long-term antibiotic prophylaxis. The primary endpoint is overall survival after 12 months of treatment. Secondary objectives are to evaluate whether the frequencies of SBP and other clinically relevant infections necessitating antibiotic treatment, as well as the total duration of unplanned hospitalization due to cirrhosis, differ in both study arms. Recruitment started in February 2014. Discussion Preventive strategies are required to avoid life-threatening infections in patients with liver cirrhosis, but unselected use of antibiotics can trigger resistant bacteria and worsen outcome. Thus, individualized approaches that direct intervention only to patients with the highest risk are urgently needed. This trial meets this need by suggesting stratified prevention based on genetic risk assessment. To our knowledge, the I N CA trial is first in the field of hepatology aimed at rapidly transferring and validating information on individual genetic risk into clinical decision algorithms. Trial registrations German Clinical Trials Register DRKS00005616 . Registered 22 January 2014. EU Clinical Trials Register EudraCT 2013-001626-26 . Registered 26 January 2015.

INTRODUCTION:Diagnostic paracentesis is recommended for patients with cirrhosis admitted to the hospital, but adherence is suboptimal with unclear impact on clinical outcomes. The aim of this meta-analysis was to assess the outcomes of early vs delayed diagnostic paracentesis among hospitalized patients with cirrhosis and ascites.METHODS:We searched multiple databases for studies comparing early vs delayed diagnostic paracentesis among hospitalized patients with cirrhosis and ascites. The pooled odds ratio (OR) and mean difference with confidence intervals (CIs) for proportional and continuous variables were calculated using the random-effects model. Early diagnostic paracentesis was defined as receiving diagnostic paracentesis within 12-24 hours of admission. The primary outcome was in-hospital mortality. Secondary outcomes were length of hospital stay, acute kidney injury, and 30-day readmission.RESULTS:Seven studies (n = 78,744) (n = 45,533 early vs n = 33,211 delayed diagnostic paracentesis) were included. Early diagnostic paracentesis was associated with lower in-hospital mortality (OR 0.61, 95% CI 0.46-0.82, P = 0.001), length of hospital stay (mean difference −4.85 days; 95% CI −6.45 to −3.20; P < 0.001), and acute kidney injury (OR 0.62, 95% CI 0.42-0.92, P = 0.02) compared with delayed diagnostic paracentesis, with similar 30-day readmission (OR 1.11, 95% CI 0.52-2.39, P = 0.79). Subgroup analysis revealed consistent results for in-hospital mortality whether early diagnostic paracentesis performed within 12 hours (OR 0.51, 95% CI 0.32-0.79, P = 0.003, I2 = 0%) or within 24 hours of admission (OR 0.67, 95% CI 0.45-0.98, P = 0.04, I2 = 82%). Notably, the mortality OR was numerically lower when diagnostic paracentesis was performed within 12 hours, and the results were precise and homogenous (I2 = 0%).DISCUSSION:Findings from this meta-analysis suggest that early diagnostic paracentesis is associated with better patient outcomes. Early diagnostic paracentesis within 12 hours of admission may be associated with the greatest mortality benefit. Data from large-scale randomized trials are needed to validate our findings, especially if there is a greater mortality benefit for early diagnostic paracentesis within 12 hours.

The clinical course of cirrhosis has been typically described by a compensated and a decompensated state based on the absence or, respectively, the presence of any of bleeding, ascites, encephalopathy or jaundice. More recently, it has been recognized that increasing portal hypertension and several major clinical events are followed by a marked worsening in prognosis, and disease states have been proposed accordingly in a multistate model. The development of multistate models implies the assessment of the probabilities of more than one possible outcome from each disease state. This requires the use of competing risks analysis which investigates the risk of several competing outcomes. In such a situation, the Kaplan–Meier risk estimates and the Cox regression may be not appropriate. Clinical states of cirrhosis presently considered as suitable for a comprehensive multistate model include: in compensated cirrhosis, early (mild) portal hypertension with hepatic venous pressure gradient (HVPG) >5 and <10 mmHg, clinically significant portal hypertension (HVPG ≥ 10 mmHg) without gastro-esophageal varices (GEV), and GEV; in decompensated cirrhosis, a first variceal bleeding without other decompensating events, any first non-bleeding decompensation and any second decompensating event; and in a late decompensation state, refractory ascites, sepsis, renal failure, recurrent encephalopathy, profound jaundice, acute on chronic liver failure, all predicting a very short survival. In this review, we illustrate how competing risks analysis and multistate models may be applied to cirrhosis.

Purpose This study aimed to evaluate the utility of peritoneovenous shunt (PVS) placement for refractory ascites (RA) based on preoperative biomarkers. Methods This retrospective cohort study included patients with malignant and cirrhotic RA undergoing PVS placement treated at Sumoto Itsuki Hospital between January 2001 and March 2024. The efficacy of PVSs was defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). The usefulness of the prognostic nutritional index, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio, lymphocyte-to-monocyte ratio, and C-reactive protein-to-albumin ratio as prognostic indicators for the efficiency of PVS was evaluated. Results In total, 149 consecutive patients (malignant RA, n  = 100; cirrhotic RA, n  = 49) were included in this study. PVS placement satisfied the efficacy criteria for ascites in 102 (68%) patients in the entire cohort. The estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m 2 was an independent predictor for the inefficacy of PVSs (odds ratio: 2.82, 95% CI: 1.04–7.73, P  = 0.042). Based on receiver operating characteristic curve and multivariate analysis of the entire cohort, NLR ≥ 5.8 was an independent risk factor for death within 1 week after PVS placement (odds ratio: 18.2, 95% CI: 2.07–29.7, P  = 0.016). Conclusion PVS placement for RA may be a treatment option when preoperative eGFR is > 30 mL/min/1.73 m 2 and NLR is < 5.8.

Cirrhosis complicated by ascites is associated with high mortality in ICU settings, yet reliable prognostic biomarkers remain limited. While the blood urea nitrogen-to-albumin ratio (BAR) has been identified as a prognostic marker in various critical illnesses, its role in cirrhotic patients with ascites remains underexplored. This study aimed to investigate the association between BAR and all-cause mortality (ACM) in cirrhotic patients with ascites admitted to the ICU. This retrospective cohort study analyzed data from 1516 cirrhotic patients with ascites, sourced from the Medical Information Mart for Intensive Care IV (MIMIC-IV) database (Version 3.1). The blood urea nitrogen-to-albumin ratio (BAR) was calculated using blood urea nitrogen (BUN) and serum albumin (ALB) levels, both measured within 24 h of ICU admission. Patients were stratified into tertiles based on the distribution of BAR. The primary outcome was 30-day mortality, and the secondary outcome was 90-day mortality. Kaplan-Meier survival analysis and Cox proportional hazards regression models were used to evaluate the association between BAR and mortality, adjusting for demographics, comorbidities, laboratory parameters, vital signs, and disease severity scores. Restricted cubic spline (RCS) analysis was employed to examine potential non-linear relationships. The predictive performance of BAR was compared to established clinical scoring systems, including the Child-Turcotte-Pugh (CTP) score, the Model for End-Stage Liver Disease (MELD), the Sequential Organ Failure Assessment (SOFA) score, and the Simplified Acute Physiology Score II (SAPS-II). Among the 1516 cirrhotic patients with ascites (median age: 59 years; 63.72% male), the 30-day and 90-day mortality rates were 32% and 39%, respectively. BAR levels were significantly higher in non-survivors compared to survivors [13.01 (IQR 13.74) vs. 9.61 (IQR 9.88), p  < 0.001]. Kaplan–Meier analysis demonstrated progressively worse survival across BAR quartiles (log-rank p  < 0.001 for both 30-day and 90-day outcomes). In fully adjusted Cox regression models, higher BAR (as a continuous variable) was independently associated with increased 30-day (HR 1.03, 95% CI 1.02–1.03, p  < 0.001) and 90-day mortality (HR  1.02, 95% CI 1.02–1.03, p  < 0.001). RCS analysis revealed a U-shaped association, with threshold values identified at BAR = 6.06 for 30-day mortality and BAR = 5.81 for 90-day mortality. The C-index for BAR in predicting 30-day mortality was 0.595, which was comparable to the CTP (0.585) and SIRS (0.583) scores, but lower than SOFA (0.662), SAPS-II (0.681), and MELD (0.669). Importantly, the inclusion of BAR into existing scoring systems consistently enhanced predictive accuracy. Subgroup analyses demonstrated that these associations remained robust across different age, gender, and comorbidity groups (all p-values for interaction > 0.05). An elevated BAR at ICU admission is independently and consistently associated with higher short-term and intermediate-term mortality in cirrhotic patients with ascites. BAR serves as a simple, cost-effective, and easily accessible prognostic tool that improves risk stratification when combined with established clinical scores. Early assessment of BAR may enable timely clinical interventions, potentially enhancing outcomes in critically ill cirrhotic patients with ascites.