rome and Critical-Illness

Clinical application of an antibiotic's pharmacokinetic/pharmacodynamic (PK/PD) properties may improve the outcome of severe infections. No data are available on the use of linezolid (LNZ) continuous infusion in critically ill obese patients affected by ventilator-associated pneumonia (VAP).. We conducted a prospective randomized controlled trial to compare LNZ concentrations in plasma and epithelial lining fluid (ELF), when administered by intermittent and continuous infusion (II, CI), in obese critically ill patients affected by VAP.. Twenty-two critically ill obese patients were enrolled. At the steady state, in the II group, mean ± SD total and unbound maximum-minimum concentrations (C max/C max,u - C min/Cmin,u) were 10 ± 3.7/6.8 ± 2.6 mg/L and 1.7 ± 1.1/1.2 ± 0.8 mg/L, respectively. In the CI group, the mean ± SD total and unbound plasma concentrations (C ss and C ss,u) were 6.2 ± 2.3 and 4.3 ± 1.6 mg/L, respectively. Within a minimum inhibitory concentration (MIC) range of 1-4 mg/L, the median (IQR) time LNZ plasma concentration persisted above MIC (% T > MIC) was significantly higher in the CI than the II group [100 (100-100) vs 100 (89-100), p = 0.05; 100 (100-100) vs 82 (54.8-98.8), p = 0.009; 100 (74.2-100) vs 33 (30.2-78.5), p = 0.005; respectively]. Pulmonary penetration (%) was higher in the CI group, as confirmed by a Monte Carlo simulation [98.8 (IQR 93.8-104.3) vs 87.1 (IQR 78.7-95.4); p < 0.001].. In critically ill obese patients affected by VAP, LNZ CI may overcome the limits of standard administration but these advantages are less evident with difficult to treat pathogens (MIC = 4 mg/L). These data support the usefulness of LNZ continuous infusion, combined with therapeutic drug monitoring (TDM), in selected critically ill populations.

Topics: Acetamides; Aged; Anti-Bacterial Agents; Critical Illness; Drug Monitoring; Female; Humans; Infusions, Intravenous; Linezolid; Male; Microbial Sensitivity Tests; Middle Aged; Obesity; Organ Dysfunction Scores; Oxazolidinones; Pneumonia, Ventilator-Associated; Prospective Studies; Risk Assessment; Rome

The aim of the present paper was to make a report of the 12-month clinical outcomes of the DEBELLUM (Drug-Eluting-Balloon-Evaluation-for-Lower-Limb- mUltilevel-treatMent) randomized trial.. From September 2010 to March 2011, 50 patients were randomized between drug eluting balloon (DEB, N.=25) and conventional angioplasty balloon (PTA, N.=25). Patients were symptomatic for claudication and critical limb ischemia, with de novo stenosis or occlusion in the femoropopliteal (SFA) and infrapopliteal (BTK) region. Only in the SFA primary stenting was allowed and postdilatation performed with DEB or PTA depending on the assigned group.. One hundred and twenty-two lesions were treated: 92 (75.4%) SFA, 30 (24.6%) BTK. Twenty (40%) patients presented multilevel concomitant femoropopliteal and infra-popliteal lesions. Late lumen loss (LLL) was 0.64±0.9 mm in DEB group vs. 1.81±0.1 mm in the control group (P=0.01). In non-stented segment LLL was 0.63±0.9 mm (DEB) vs. 1.70±0.6 mm (PTA), P<0.01. In the stent subgroup was LLL 0.65±0.2 mm (DEB) vs. 1.91±0.3 mm (PTA), P<0.01. In the femoropopliteal region the overall LLL was 0.61±0.8 mm for DEB vs. 1.84±0.3 mm for PTA (P=0.02). BTK the overall LLL was 0.66±0.9 mm (DEB) vs. 1.69±0.5 mm (PTA) (P=0.03). The overall TLR was 12.2% for DEB and 35.3% for PTA (P<0.05). Amputation rate was 4% (DEB) vs. 12% (PTA), P=0.36. Thrombosis was 4% (DEB) vs. 8% (PTA), P≥0.05. Major adverse events 24% (DEB) vs. 60% (PTA), P<0.05. ABI improved more in the DEB group: 0.81±0.3 vs. 0.68±0.13 (P=0.02). Fontaine stage increased (from II b to I) 80% DEB vs. 56% PTA (P<0.05).. Results confirm and reinforce initial 6-month outcomes. In.Pact DEB balloons can be considered efficient to reduce restenosis rate.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Critical Illness; Drug Carriers; Equipment Design; Female; Femoral Artery; Hemodynamics; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Risk Factors; Rome; Thrombosis; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To compare the safety and efficacy of laser debulking (LD) and drug-eluting balloon (DEB) angioplasty to treatment with DEB angioplasty alone in patients affected by critical limb ischemia (CLI) and superficial femoral artery (SFA) chronic stent occlusion in a prospective, randomized study.. Among 448 CLI patients treated from December 2009 to March 2011, 48 patients (39 men; mean age 72.7±7.8 years) with chronic SFA in-stent occlusion were randomly assigned to treatment using LD+DEB (n=24) or DEB angioplasty alone (n=24). Patency at 12 months was the primary outcome measure; secondary outcomes were target lesion revascularization (TLR) and clinical success at 12 months.. In the LD+DEB group, the patency rates at 6 and 12 months (91.7% and 66.7%, respectively) were significantly higher (p=0.01) than in the DEB only patients (58.3% and 37.5%, respectively). TLR at 12 months was 16.7% in the LD+DEB group and 50% in the DEB only group (p=0.01). Two (8%) patients needed major amputations in the LD+DEB group vs. 11 (46%) in the DEB only group at 12 months (p=0.003).. In this small initial experience, combined treatment with LD and DEB angioplasty is correlated with better outcomes in CLI patients with occluded SFA stents.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Atherectomy; Chronic Disease; Coated Materials, Biocompatible; Constriction, Pathologic; Critical Illness; Equipment Design; Female; Femoral Artery; Humans; Ischemia; Kaplan-Meier Estimate; Lasers; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Radiography; Recurrence; Retreatment; Risk Factors; Rome; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Topics: Anti-Inflammatory Agents; Critical Illness; Humans; Machine Learning; Phenotype; Rome; Sepsis

To evaluate the safety and efficacy of low-frequency, high-intensity ultrasound energy delivered via a new dedicated ultrasound catheter followed by conventional balloon angioplasty to treat calcified infrapopliteal lesions.. A prospective, nonrandomized, single-center pilot study enrolled 12 patients (mean age 72.2±5.3 years; 8 men) with critical limb ischemia (9 Rutherford category 5 and 3 category 6) between January and November 2017. Of the 19 target lesions, 11 had severe calcification. Patients were treated with the Kapani ultrasound system before conventional balloon dilation. Primary safety endpoints included 30-day death, major target limb amputation, and target vessel acute occlusion. The main efficacy outcome was primary patency at 6 months, defined as freedom from both clinically-driven target lesion revascularization (TLR) and angiographically-defined restenosis (>50% lumen reduction).. Technical success (<30% residual stenosis) was achieved in all lesions without complications or stent implantation. Ultrasound energy was delivered over a mean 185.2±67.3 seconds followed by low-pressure dilation (mean 6.1±1.9 atm). Angiography confirmed primary patency at 6 months in 18 (95%) of 19 lesions. No death, TLR, or amputation was reported in follow-up. Complete ulcer healing was observed in all 12 patients at 6 months.. This pilot trial with a small number of patients suggests that low-frequency, high-intensity ultrasound energy delivery followed by plain balloon angioplasty is a safe approach to treat infrapopliteal atherosclerotic lesions. Angiographically-documented results at 6 months indicate a potential for this combined therapy in the treatment of CLI patients with calcified BTK lesions. Further studies on a larger randomized cohort are needed to confirm these positive clinical outcomes.

Topics: Aged; Amputation, Surgical; Angiography; Angioplasty, Balloon; Critical Illness; Female; Humans; Ischemia; Leg; Limb Salvage; Male; Peripheral Arterial Disease; Pilot Projects; Popliteal Artery; Predictive Value of Tests; Prospective Studies; Recurrence; Rome; Time Factors; Treatment Outcome; Ultrasonic Therapy; Vascular Access Devices; Vascular Patency

The aim of this study is to analyze the effects of peripheral blood mononuclear cells (PBMNCs) therapy in diabetic patients with critical limb ischemia (CLI), with particular regard to its application, as adjuvant therapy in patients underwent endovascular revascularization.. Fifty diabetic patients affected by CLI were enrolled. All patients underwent PBMNCs therapy. Thirty-two patients underwent PBMNCs therapy associated with endovascular revascularization (adjuvant therapy group). In 18 patients, who were considered nonrevascularizable or underwent unsuccessful revascularization, regenerative therapy with PBMNCs was performed as the therapeutic choice (PBMNCs therapy group).. The role of cellular therapy with PBMNCs is decisive in the patients that are not susceptible to revascularization. In diabetic patients with CLI and healing resistant ulcers, the adjuvant PBMNCs therapy could represent a valid therapeutic option.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Critical Illness; Disease Progression; Endovascular Procedures; Female; Foot Ulcer; Humans; Ischemia; Leukocytes, Mononuclear; Limb Salvage; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Recovery of Function; Risk Factors; Rome; Time Factors; Treatment Outcome; Wound Healing

Mortality among critically ill children requiring continuous renal replacement therapy (CRRT) is high. Several factors have been identified as outcome predictors. Many studies have specifically reported a positive association between the fluid overload at CRRT initiation and the mortality of critically ill pediatric patients.. This study is a retrospective single-center analysis including all patients admitted to the pediatric intensive care unit (PICU) of our hospital who received CRRT between 2000 and 2012. One hundred thirty-one patients were identified and subsequently classified according to primary disease. Survival rates, severity of illness and fluid balance differed among subgroups. The primary outcome was patient survival to PICU discharge.. Overall survival to PICU discharge was 45.8 %. Based on multiple regression analysis, mortality was independently associated with onco-hematological disease [odds ratio (OR) 11.7, 95 % confidence interval (CI) 1.3-104.7; p = 0.028], severe multiple organ dysfunction syndrome (MODS) (OR 5.1, 95 % CI 1.7-15; p = 0.003) and hypotension (OR 11.6, 95 % CI 1.4-93.2; p = 0.021). In the subgroup analysis, a fluid overload (FO) of more than 10 % (FO>10 %) at the beginning of CRRT seems to be a negative predictor of mortality (OR 10.9, 95 % CI 0.78-152.62; p = 0.07) only in children with milder disease (renal patients). Due to lack of statistical power, the independent effect of fluid overload on mortality could not be analyzed in all subgroups of patients.. In children treated with CRRT the underlying diagnosis and severity of illness are independent risk factors for mortality. The degree of FO is a negative predictor only in patients with milder disease.

Topics: Acute Kidney Injury; Adolescent; Chi-Square Distribution; Child; Child Mortality; Child, Preschool; Critical Illness; Female; Hemodynamics; Hospital Mortality; Humans; Infant; Infant, Newborn; Intensive Care Units, Pediatric; Kaplan-Meier Estimate; Logistic Models; Male; Multiple Organ Failure; Multivariate Analysis; Odds Ratio; Proportional Hazards Models; Renal Replacement Therapy; Retrospective Studies; Risk Assessment; Risk Factors; Rome; Severity of Illness Index; Time Factors; Treatment Outcome; Water-Electrolyte Balance; Water-Electrolyte Imbalance