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30 result(s) for "Paracentesis - statistics "
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Feasibility of a fast-track randomized controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with refractory malignant ascites
Background Malignant ascites often causes discomfort in advanced cancer patients. Paracentesis is the most common treatment modality, but it requires frequently repeated treatment. Cell-free and concentrated ascites reinfusion therapy (CART) may prolong the paracentesis interval, but controlled trials are lacking. We assessed the feasibility of a randomized controlled trial of CART vs. paracentesis alone for patients with refractory malignant ascites. Methods This study was an open-label, fast-track, randomized controlled, feasibility trial. Patients admitted to four designated cancer hospitals who received no further anticancer treatments were eligible. Patients were randomly assigned 1:1 to a CART arm or control (simple paracentesis) arm. The feasibility endpoint was the percentage of patients who completed the study intervention. Secondary endpoints included paracentesis-free survival, patient’s request on the questionnaire for paracentesis (PRO-paracentesis)-free survival (the period until the patients first reported that they would want paracentesis if indicated), and adverse events. Results We screened 953 patients for eligibility. Of 61 patients with refractory malignant ascites, 21 patients were determined as eligible. Finally, 20 patients consented and were allocated; 18 patients (90%, 95% CI: 68.3–98.8) completed the study intervention. All patients had an ECOG performance status of 3 or 4. The median drained ascites volume was 3,200 mL in the CART arm and 2,500 mL in the control arm. In the CART arm, the median reinfused albumin volume was 12.6 g. Median paracentesis-free survivals were 5 days (95% CI: 2–6) in the CART arm, and 6 days (3–9) in the control arm. Median PRO-paracentesis-free survivals were 4 days (2–5) and 5 days (1–9), respectively. A total of 73% of patients received paracentesis within 2 days from their first request for the next paracentesis. One patient in the CART arm developed Grade 1 fever. Conclusions A fast-track randomized controlled trial of CART for patients with malignant ascites is feasible. The efficacy and safety of CART should be assessed in future trials. PRO-paracentesis-free survival may be a complementary outcome measure with paracentesis-free survival in future trials. Trial registration Registered at University Hospital Medical Information Network Clinical Trial Registry as UMIN000031029 . Registered on 28/01/2018.
Pleural procedures and patient safety: a national BTS audit of practice
The BTS pleural procedures audit collected data over a 2-month period in June and July 2011. In contrast with the 2010 audit, which focussed simply on chest drain insertions, data on all pleural aspirations and local anaesthetic thoracoscopy (LAT) was also collected. Ninety hospitals submitted data, covering a patient population of 33 million. Twenty-one per cent of centres ran a specialist pleural disease clinic, 71% had a nominated chest drain safety lead, and 20% had thoracic surgery on site. Additionally, one-third of centres had a physician-led LAT service.
Early Paracentesis in High-Risk Hospitalized Patients: Time for a New Quality Indicator
Symptomatic ascites is the most common indication for hospitalization in patients with cirrhosis. Although guidelines recommend paracentesis for all inpatients with ascites, the timing of paracentesis is likely to be crucial. Performance of an early paracentesis and its relationship to outcomes are unknown, particularly among patients at high risk of spontaneous bacterial peritonitis (SBP). We included 75,462 discharges of adult patients with cirrhosis presenting with ascites who underwent paracentesis from the State Inpatient Databases of New York, Florida, and Washington from 2009 to 2013. High-risk patients were identified as having concomitant hepatic encephalopathy or acute kidney injury present on admission. The primary outcome was performance of early paracentesis (within 1 hospital day) with secondary outcomes being inpatient mortality, SBP-related mortality, and 30-day readmission. Multivariable logistic regression models included a priori covariates known to impact outcomes. There were 43,492 (57.6%) patients who underwent early paracentesis. High-risk patients (27,496) had lower rates of early paracentesis (52.8% vs 60.5%, P < 0.001). On multivariable analysis, high-risk patients had significantly decreased odds of undergoing early paracentesis (odds ratio [OR] 0.74, 95% confidence interval [CI] 0.71-0.78, P < 0.001). Early paracentesis was associated with a reduced inpatient all-cause mortality (OR 0.68, 95% CI 0.63-0.73, P < 0.001), SBP-related mortality (OR 0.84, 95% CI 0.73-0.94, P = 0.01), and 30-day readmission (OR 0.87, 95% CI 0.82-0.92, P < 0.001). Early paracentesis is associated with reduced inpatient mortality, SBP-related mortality, and 30-day readmission. Given its impact on outcomes, early paracentesis should be a new quality metric. Further education and interventions are needed to improve both adherence and outcomes.
Racial and Ethnic Disparities in Outcomes After the Development of Ascites: A National Cohort Study
IntroductionAscites, a severe complication of cirrhosis, significantly impacts patient morbidity and mortality especially in Black patients. Access to disease optimizing care has been proposed as a potential driver of this disparity. In this study, we evaluate TIPS utilization across racial and ethnic groups.MethodsWe examined data from a 20% random sample of US Medicare enrollees with continuous Part D coverage. We required 180 days of continuous outpatient enrollment prior to cirrhosis diagnosis and all patients had ≥1 paracentesis within 180 days of their cirrhosis diagnosis. Time zero was the date of the first paracentesis. We assessed the likelihood of TIPS placement. Analyses were conducted to determine the independent associations between each outcome and race/ethnicity.Results5915 patients (average age 68.2, 64.4% male) were included in the analysis. 439 (7.4%) patients were identified as Black, 223 (3.8%) as Hispanic, and 4942 (83.6%) as white. When compared to white patients in a multivariable analysis, Black patients were less likely to receive a TIPS procedure (hazard ratio 0.4; 95% confidence interval (CI) 0.2–0.8) and had less days alive outside of the hospital (−100.5; 95% CI −189.4 – −11.6). There were no significant differences in transplant-free survival or number of paracenteses per year between ethnic and racial groups.ConclusionBlack patients are less likely to receive a TIPS procedure when controlling for common patient- and disease-specific variables. Access to optimal specialized services may be a significant driver for disparities in outcomes of patients with cirrhosis between racial and ethnic groups.
A dedicated paracentesis clinic decreases healthcare utilization for serial paracenteses in decompensated cirrhosis
PurposeThe purpose of the study is to describe the effect of a dedicated paracentesis clinic on healthcare utilization by patients with decompensated cirrhosis and refractory ascites.MethodsThis Institutional Review Board-approved retrospective study identified cirrhotic patients receiving paracenteses over a 6-month period before and after creating the paracentesis clinic. Patients were followed for 12 months to collect outcome data including characteristics of subsequent hospitalizations and paracenteses. Logistic regression was used to examine the association between the paracentesis clinic and outcomes.ResultsThere were 183 patients and 1364 paracenteses performed during the study time period. Age, gender, cirrhosis etiology, MELD, Child–Pugh, and Charlson comorbidity index were comparable between the two groups. Rates of mortality, transplant, and hospitalization were also similar during 1 year follow-up. After establishment of the paracentesis clinic, median paracenteses per patient increased from 2 (IQR 1–7) to 4 (IQR 2–11) (P = 0.01); albumin replacement after paracenteses ≥ 5 L improved from 76.3% to 91.7% (P < 0.001); and the fraction of outpatient paracenteses performed in the emergency department decreased from 13.4% to 3.8% (P < 0.001). Major complications remained negligible at 0.81% across both time periods. While fewer patients were admitted for ascites after the paracentesis clinic (39.6% vs. 20.8%, P = 0.009), more patients had acute kidney injury (AKI) during follow-up (47.2% vs. 65.9%, P = 0.02), with a trend towards more AKI admissions (22.6% vs. 35.4%, P = 0.09).ConclusionA dedicated paracentesis clinic can improve access and wait times, while also reducing admissions for ascites and paracenteses performed in the emergency department.
How spontaneous pneumothorax is managed in emergency departments: a French multicentre descriptive study
Background Management of spontaneous pneumothorax (SP) is still subject to debate. Although encouraging results of recent studies about outpatient management with chest drains fitted with a one-way valve, no data exist concerning application of this strategy in real life conditions. We assessed how SP are managed in Emergency departments (EDs), in particular the role of outpatient management, the types of interventions and the specialty of the physicians who perform these interventions. Methods From June 2009 to May 2013, all cases of spontaneous primary (PSP) and spontaneous secondary pneumothorax (SSP) from EDs of 14 hospitals in France were retrospectively included. First line treatment (observation, aspiration, thoracic drainage or surgery), type of management (admitted, discharged to home directly from the ED, outpatient management) and the specialty of the physicians were collected from the medical files of the ED. Results Among 1868 SP included, an outpatient management strategy was chosen in 179 PSP (10%) and 38 SSP (2%), mostly when no intervention was performed. Only 25 PSP (1%) were treated by aspiration and discharged to home after ED admission. Observation was the chosen strategy for 985 patients (53%). In 883 patients with an intervention (47%), it was performed by emergency physicians in 71% of cases and thoracic drainage was the most frequent choice (670 patients, 76%). Conclusions Our study showed the low level of implementation of outpatient management for PS in France. Despite encouraging results of studies concerning outpatient management, chest tube drainage and hospitalization remain preponderant in the treatment of SP.
Elderly patients are at increased risk for treatment failure in outpatient management of purulent skin infections
Current Infectious Disease Society of America (IDSA) guidelines for the management of purulent skin or soft tissue infections do not account for patient age in treatment recommendations. The study objective was to determine if age was associated with outpatient treatment failure for purulent skin infection after adjusting for IDSA treatment guidelines. We conducted a multicenter retrospective study of adult patients treated for a purulent skin infection and discharged home from four emergency departments between April and September 2014. Patients were followed for one month to assess for treatment failure (defined as need for a change in antibiotics, surgical intervention, or hospitalization). We used multivariable logistic regression to examine the role of patient age on treatment failure adjusting for demographic variables (gender, race), comorbidities and severity of infection. A total of 467 patients met inclusion criteria (mean age 37.9years [SD 14.0], 48.2% of whom were women). Overall, 12.4% failed initial therapy. Patients 65years and older (n=35) were almost 4 times more likely to fail initial ED therapy in follow-up compared with younger patients (adjusted Odds Ratio (OR) 3.87, 95% Confidence Interval (CI) 1.24–12.10). After adjustment, for every 10years of advancing age there was a 43% increased odds of failing initial treatment (OR 1.43 95% CI 1.09–1.88). Elderly patients with purulent skin infections, whose providers followed the 2014 IDSA guidelines, were more likely to fail initial treatment than younger patients. This study suggests that there is a need to re-evaluate treatment guidelines in elderly patients.
Subconjunctival reflux and need for paracentesis after intravitreal injection of 0.1 ml bevacizumab: comparison between 27-gauge and 30-gauge needle
Purpose Intravitreal injections may lead to a significant elevation of the intraocular pressure (IOP). A paracentesis may become necessary for acute reduction of the IOP in certain cases. The purpose of this study was to determine the frequency of paracentesis performed and the grade of reflux under the conjunctiva after injection of 0.1 ml bevacizumab (1.25 mg), depending on the thickness of the needles used. Methods A retrospective review was undertaken of the surgery reports of 234 consecutive intravitreal bevacizumab injections in 145 eyes of 144 patients within 14 months. In particular, the frequency of paracentesis, the thickness of the needles used (27-gauge versus 30-gauge), the lens status, and a semi-quantitative reflux grade were analysed. Results A paracentesis was performed in 78 cases (33%) for acute reduction of the IOP. In the 27-gauge group the frequency was 26% (25 of 96), and in the 30-gauge group 38% (53 of 138) ( p  = 0.05, independent estimating equation (IEE)). The medians of the semi-quantitative assessment of the reflux grade under the conjunctiva were 2.0 in the 27-gauge group (corresponding to a mild reflux) and 1.0 in the 30-gauge group (corresponding to a minimal reflux, p  < 0.001, IEE). Conclusions When using a 30-gauge needle for intravitreal injections, the reflux under the conjunctiva was less than with a 27-gauge needle. However, the use of a 30-gauge needle appeared to be associated with a higher frequency of paracentesis.
Development and validation a simple model for identify malignant ascites
The differential diagnosis of benign ascites and malignant ascites is incredibly challenging for clinicians. This research aimed to develop a user-friendly predictive model to discriminate malignant ascites from non-malignant ascites through easy-to-obtain clinical parameters. All patients with new-onset ascites fluid were recruited from January 2014 to December 2018. The medical records of 317 patients with ascites for various reasons in Renmin Hospital of Wuhan University were collected and reviewed retrospectively. Thirty-six parameters were included and selected using univariate logistic regression, multivariate logistic regression, and receiver operating characteristic (ROC) curve analyses to establish a mathematical model for differential diagnosis, and its diagnostic performance was validated in the other groups. Age, cholesterol, hypersensitivity C-reactive protein (hs-CRP) in serum, ascitic fluid adenosine deaminase (AF ADA), ascitic fluid lactate dehydrogenase (AF LDH) involvement in a 5-marker model. With a cut-off level of 0.83, the sensitivity, specificity, accuracy, and area under the ROC of the model for identifying malignant ascites in the development dataset were 84.7%, 88.8%, 87.6%, and 0.874 (95% confidence interval [CI], 0.822-0.926), respectively, and 80.9%, 82.6%, 81.5%, and 0.863 (95% CI,0.817-0.913) in the validation dataset, respectively. The diagnostic model has a similar high diagnostic performance in both the development and validation datasets. The mathematical diagnostic model based on the five markers is a user-friendly method to differentiate malignant ascites from benign ascites with high efficiency.
TIPS for Management of Refractory Ascites: Response and Survival Are Both Unpredictable
Refractory ascites is a serious complication of advanced cirrhosis with a 1-year transplant-free survival of 20-50%. The aim of our study was to investigate the short- and long-term effects of transjugular intrahepatic portosystemic shunt (TIPS) in the management of refractory ascites. In all 65 patients (39 M, 26 F; Child B 55%, Child C 45%, mean MELD score 14.8 +/- 6.6) with liver disease (alcoholic 40%, cryptogenic 20%, HCV 14%, others 26%) and refractory ascites were included in this study. Forty-eight (74%) patients had no signs of hepatic encephalopathy (HE), 16 (24%) had mild and 1 (2%) had moderate HE before TIPS; 28 (43%) had mild (> 1.2 and < 2.4 mg/dl) and 6 patients (9%) had moderate (> 2.4 mg/dl) renal dysfunction. Mean follow-up was 55.5 +/- 70.2 weeks. Treatment success, defined as complete response, partial response, and no response, and survival was determined at 3 weeks, and 3, 6, 12, 24, and 36 months after TIPS. TIPS was successful in all patients. Mean portal venous pressure gradient improved significantly after TIPS (24 +/- 8 to 10 +/- 4). During follow-up, 40 (58%) patients died and 17 (27%) patients had liver transplantation (OLT); 20 (31%) patients had 38 shunt revisions due to lack of initial response or recurrence of ascites. The response was assessed in patients who were alive, without OLT, at each time point. Complete response was seen in 10%, 23%, 17%, 11%, 22% and 33%; partial response was seen in 46%, 46%, 40%, 44%, 28%, and 8%; and no response was seen in 44%, 31%, 43%, 41 %, 39%, and 50% at 3 weeks, and 3, 6, 12, 24, and 36 months respectively. There were no pre-TIPS variables that could predict the response at 3 weeks, 3 months, or 6 months. Mild HE was seen in 8 (12%) patients and severe HE was seen in 16 (25%) immediately after TIPS. The mortality at 3 weeks, and 3, 6, 12, 24, and 36 months was 26%, 38%, 46%, 51%, 57%, and 58%, respectively. Three-week (P = 0.01) and 3-month (P = 0.04) mortality was higher in Child C patients compared to Child B. However, there were no independent predictors of survival on multivariate analysis at 3 or 6 months. Child-Pugh score 3 weeks after TIPS was a strong predictor of mortality. In conclusion, in patients with refractory ascites, TIPS was associated with a high mortality and morbidity. The response and the mortality were both unpredictable on the basis of pretransplant variables.