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Purpose To test whether the polymyxin B hemoperfusion (PMX HP) fiber column reduces mortality and organ failure in peritonitis-induced septic shock (SS) from abdominal infections. Method Prospective, multicenter, randomized controlled trial in 18 French intensive care units from October 2010 to March 2013, enrolling 243 patients with SS within 12 h after emergency surgery for peritonitis related to organ perforation. The PMX HP group received conventional therapy plus two sessions of PMX HP. Primary outcome was mortality on day 28; secondary outcomes were mortality on day 90 and a reduction in the severity of organ failures based on Sequential Organ Failure Assessment (SOFA) scores. Results Primary outcome: day 28 mortality in the PMX HP group ( n  = 119) was 27.7 versus 19.5 % in the conventional group ( n  = 113), p  = 0.14 (OR 1.5872, 95 % CI 0.8583–2.935). Secondary endpoints: mortality rate at day 90 was 33.6 % in PMX-HP versus 24 % in conventional groups, p  = 0.10 (OR 1.6128, 95 % CI 0.9067–2.8685); reduction in SOFA score from day 0 to day 7 was −5 (−11 to 6) in PMX-HP versus −5 (−11 to 9), p  = 0.78. Comparable results were observed in the predefined subgroups (presence of comorbidity; adequacy of surgery, <2 sessions of hemoperfusion) and for SOFA reduction from day 0 to day 3. Conclusion This multicenter randomized controlled study demonstrated a non-significant increase in mortality and no improvement in organ failure with PMX HP treatment compared to conventional treatment of peritonitis-induced SS.

We report on the effect of hemoadsorption therapy to reduce cytokines in septic patients with respiratory failure. This was a randomized, controlled, open-label, multicenter trial. Mechanically ventilated patients with severe sepsis or septic shock and acute lung injury or acute respiratory distress syndrome were eligible for study inclusion. Patients were randomly assigned to either therapy with CytoSorb hemoperfusion for 6 hours per day for up to 7 consecutive days (treatment), or no hemoperfusion (control). Primary outcome was change in normalized IL-6-serum concentrations during study day 1 and 7. 97 of the 100 randomized patients were analyzed. We were not able to detect differences in systemic plasma IL-6 levels between the two groups (n = 75; p = 0.15). Significant IL-6 elimination, averaging between 5 and 18% per blood pass throughout the entire treatment period was recorded. In the unadjusted analysis, 60-day-mortality was significantly higher in the treatment group (44.7%) compared to the control group (26.0%; p = 0.039). The proportion of patients receiving renal replacement therapy at the time of enrollment was higher in the treatment group (31.9%) when compared to the control group (16.3%). After adjustment for patient morbidity and baseline imbalances, no association of hemoperfusion with mortality was found (p = 0.19). In this patient population with predominantly septic shock and multiple organ failure, hemoadsorption removed IL-6 but this did not lead to lower plasma IL-6-levels. We did not detect statistically significant differences in the secondary outcomes multiple organ dysfunction score, ventilation time and time course of oxygenation.

The aim of this proof of concept, prospective, randomized pilot trial was to investigate the effects of extracorporeal cytokine removal (CytoSorb®) applied as a standalone treatment in patients with septic shock. 20 patients with early (<24 h) onset of septic shock of medical origin, on mechanical ventilation, norepinephrine>10 μg/min, procalcitonin (PCT) > 3 ng/mL without the need for renal replacement therapy were randomized into CytoSorb (n = 10) and Control groups (n = 10). CytoSorb therapy lasted for 24 h. Clinical and laboratory data were recorded at baseline (T0), T12, T24, and T48 hours. Overall SOFA scores did not differ between the groups. In the CytoSorb-group norepinephrine requirements and PCT concentration decreased significantly (norepinephrine: CytoSorb: T0 = 0.54[IQR:0.20–1.22], T48 = 0.16[IQR:0.07–0.48], p = .016; Controls: T0 = 0.43[IQR:0.19–0.64], T48 = 0.25[IQR:0.08–0.65] μg/kg/min; PCT: CytoSorb: T0 median = 20.6[IQR: 6.5–144.5], T48 = 5.6[1.9–54.4], p = .004; Control: T0 = 13.2[7.6–47.8], T48 = 9.2[3.8–44.2]ng/mL). Big-endothelin-1 concentrations were also significantly lower in the CytoSorb group (CytoSorb: T0 = 1.3 ± 0.6, *T24 = 1.0 ± 0.4, T48 = 1.4 ± 0.8, *p = .003; Control: T0 = 1.1 ± 0.7, T24 = 1.1 ± 0.6, T48 = 1.2 ± 0.6 pmol/L, p = .115). There were no CytoSorb therapy-related adverse events. This is the first trial to investigate the effects of early extracorporeal cytokine adsorption treatment in septic shock applied without renal replacement therapy. It was found to be safe with significant effects on norepinephrine requirements, PCT and Big-endothelin-1 concentrations compared to controls. Trial registration: The study has been registered on ClinicalTrials.gov, under the registration number of NCT02288975, registered 13 November 2014. •First randomized trial on one single 24-hour period of standalone CytoSorb treatment•Medical patients with septic shock were randomized (CytoSorb treated or control)•Patients were treated for 24 h with CytoSorb in addition to standard treatment•Significant reduction (70%) in norepinephrine requirement, PCT and Big Endothelin-1

Background Recent randomized trials have not found that polymyxin B hemoperfusion (PMX-HP) improves outcomes for patients with sepsis. However, it remains unclear whether the therapy could provide benefit for highly selected patients. Monocyte human leukocyte antigen (mHLA-DR) expression, a critical step in the immune response, is decreased during sepsis and leads to worsening sepsis outcomes. One recent study found that PMX-HP increased mHLA-DR expression while another found that the treatment removed HLA-DR-positive cells. Methods We conducted a randomized controlled trial in patients with blood endotoxin activity assay (EAA) level ≥ 0.6. Patients in the PMX-HP group received a 2-h PMX-HP treatment plus standard treatment for 2 consecutive days. Patients in the non-PMX-HP group received only standard treatment. The primary outcome compared the groups on median change in mHLA-DR expression between day 3 and baseline. Secondary outcomes compared the groups on the mean or median change in CD11b expression, neutrophil chemotaxis, presepsin, cardiovascular Sequential Organ Failure Assessment (CVS SOFA) score, vasopressor dose, and EAA level between day 3 and baseline. We further compared the groups on mortality, ICU-free days, ventilator-free days, dialysis dependence status, renal recovery, serum creatinine, vasopressor-free days, and major adverse kidney events (MAKE 28), measured on day 28. Results Fifty-nine patients were randomized to PMX-HP ( n  = 29) and non-PMX-HP ( n  = 30) groups. At baseline, mHLA-DR expression, CD11b, neutrophil chemotaxis, and clinical parameters were comparable between groups. The median change in mHLA-DR expression between day 3 and baseline was higher in PMX-HP patients than in patients receiving standard therapy alone ( P  = 0.027). The mean change in CD11b between day 3 and baseline was significantly lower in the PMX-HP group than in the non-PMX-HP group ( P  = 0.002). There were no significant changes from baseline in neutrophil chemotaxis, presepsin, CVS SOFA scores, vasopressor doses, or EAA level between groups. On day 28 after enrollment, mortality, ICU-free days, ventilator-free days, dialysis dependence status, renal recovery, serum creatinine, vasopressor-free days, and MAKE 28 were comparable between groups. Conclusion PMX-HP improved mHLA-DR expression in severe sepsis patients. Future studies should examine the potential benefit of PMX-HP in patients with low mHLA-DR expression. Trial registration ClinicalTrials.gov, NCT02413541 . Registered on 3 March 2015. 

The evidence supporting additional hemoperfusion (HP) with cytokine adsorbents for improving clinical outcomes in severe to critical coronavirus disease 2019 (COVID-19) patients remains limited. We compared severe to critical COVID-19 patients who received additional HP with a cytokine adsorbent to matched cases receiving standard medical treatment (SMT). The primary outcome was hospital mortality. In our study, we matched 45 patients who received additional HP 1:1 with the SMT group based on key clinical parameters. The hospital mortality rates did not differ between the groups (33% vs 38%, p  = 0.83). The HP group had a significantly shorter ICU stay (22 vs 32 days; p = 0.017) and reduced mechanical ventilation duration (15 vs 35 days; p  < 0.001). Additionally, the incidence of pulmonary complications (20% vs 42%; p = 0.04), sepsis (38% vs 64%; p  = 0.02), and disseminated intravascular coagulopathy (DIC) (13% vs 33%; p  = 0.046) were significantly lower in the HP group. In conclusion, among severe to critical COVID-19 patients, additional HP with a cytokine adsorbent did not improve hospital mortality. However, it reduced ICU length of stay, mechanical ventilator days, and incidences of lung complications, sepsis, and DIC. Trial registration : TCTR20231002006. Registered 02 October 2023 (retrospectively registered).

IntroductionMyoglobin (Mb) exerts both direct and indirect nephrotoxic effects, contributing to the progression of kidney injury. For patients with rhabdomyolysis (RM) and acute kidney injury (AKI) requiring renal replacement therapy (RRT), Mb clearance is a critical therapeutic goal. Recent studies have indicated that haemoadsorption (HA) combined with continuous renal replacement therapy (CRRT) is an effective strategy for removing circulating Mb. However, clinical data regarding the efficiency of Mb clearance and long-term patient outcomes with this approach remain limited. This study aims to evaluate the efficacy and safety of HA combined with CRRT in treating severe RM and AKI.Methods and analysisThis single-center, open-label, randomised controlled trial will be conducted at West China Hospital of Sichuan University. A total of 60 patients with severe RM and AKI will be enrolled and randomly assigned in a 1:1 ratio to either the CRRT group or the CRRT+HA group. Randomisation will be conducted by drawing lots, performed by the patient’s legal representative (with ‘0’ indicating the CRRT group and ‘1’ indicating the CRRT+HA group).The primary outcome of the study is the plasma clearance of Mb. Secondary outcomes include the plasma clearance of creatine kinase, haemodynamic changes, changes in acute physiology and chronic health II (APACHE) II score and sequential organ failure assessment (SOFA) score, renal function recovery, length of hospital stay, all-cause mortality, and pre- and post-treatment changes in albumin, platelet and haemoglobin counts. Data will be analysed using both intention-to-treat and per-protocol analysis methods.Ethics and disseminationThe study will comply with the Declaration of Helsinki and the Chinese Clinical Trials Act. The study protocol has been approved by the Biomedical Research Ethics Committee of West China Hospital of Sichuan University (2024.1914). Written informed consent will be obtained from all participants. The study results will be presented at academic meetings and in peer-reviewed academic journals.Trial registration numberChiCTR2400092176.

Background Septic shock is common and has unacceptably high morbidity, mortality, and associated cost with numerous failed attempts at developing effective therapies. Endotoxin, one of the most potent mediators of sepsis, is found in high levels in approximately 50% of patients with septic shock. Polymyxin B (PMX) hemoperfusion has been shown in numerous studies to successfully remove endotoxin and potentially improve outcomes. EUPHRATES (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock) is a theragnostic trial (matching blood measurement to treatment capability) of PMX hemoperfusion in patients with septic shock and confirmed endotoxemia as measured by the endotoxin activity assay (EAA). Methods EUPHRATES is a pivotal regulatory trial that is multi-centered, placebo-controlled and blinded. The trial is being conducted in fifty ICUs in the United States and Canada and is powered to enroll 360 patients. Patients with persistent septic shock despite adequate fluid resuscitation on vasopressors for more than 2 and less than 30 hours are eligible for measurement of the EAA. Those with EAA ≥0.60 are eligible to be randomized to treatment with two sessions of PMX hemoperfusion 24 hours apart. The primary endpoint for the trial is 28-day all-cause mortality. Discussion Unique features of the trial include absence of systemic inflammatory response (SIRS) criteria as a requirement for inclusion, use of the EAA to confirm endotoxemia as a requisite for treatment, and use of a detailed “façade” hemoperfusion event as a blinding mechanism. The outcomes of the second interim analysis included a resizing of the trial to 650 patients and the addition of an exclusion criterion of subjects with multiple organ dysfunction score (MODS) ≤ 9. Results are anticipated in 2016. Trial registration Clinicaltrials.gov identifier: NCT01046669 . Registered: January 8, 2010.

This study aimed to investigate the effectiveness of continuous renal replacement therapy and hemoperfusion in acute severe organophosphorus pesticide poisoning patients. Fifty-eight acute severe organophosphorus pesticide poisoning patients who accepted therapy in Nangjing First Hospital, Nangjing Medical University from January 2018 to December 2022 were chosen as the study participants. They were randomly divided into a control group and a research group. Both groups received conventional treatment, while the research group received continuous renal replacement therapy combined with hemoperfusion therapy. Relative to the control group, the research group had higher total effectiveness rate, shorter coma time, cholinase recovery time, reduced stay in intensive care unit, less atropine dosage, lower levels of inflammatory factors and lower sequential organ failure assessment scores. Our study suggests that continuous renal replacement therapy combined with hemoperfusion can improve the clinical therapeutic effect in patients with acute severe organophosphorus pesticide poisoning, effectively control the inflammatory response, and shorten the clinical rescue and treatment time of patients. Cette étude visait à évaluer l'efficacité de la suppléance rénale continue et de l'hémoperfusion chez les patients atteints d'intoxication aiguë sévère aux pesticides organophosphorés. Cinquante-huit patients atteints d'intoxication aiguë sévère aux pesticides organophosphorés, admis au traitement au Nangjing First Hospital de l'Université de médecine de Nangjing entre janvier 2018 et décembre 2022, ont été sélectionnés comme participants à l'étude. Ils ont été répartis aléatoirement en un groupe témoin et un groupe de recherche. Les deux groupes ont reçu un traitement conventionnel, tandis que le groupe de recherche a reçu une suppléance rénale continue associée à une hémoperfusion. Par rapport au groupe témoin, le groupe de recherche présentait un taux d'efficacité globale plus élevé, une durée de coma plus courte, un temps de récupération de la cholinase plus court, une durée d'hospitalisation réduite en unité de soins intensifs, une dose d'atropine plus faible, des taux de facteurs inflammatoires plus faibles et des scores d'évaluation de la défaillance organique séquentielle plus faibles. Notre étude suggère que la suppléance rénale continue associée à l'hémoperfusion peut améliorer l'effet thérapeutique clinique chez les patients atteints d'intoxication aiguë sévère aux pesticides organophosphorés, contrôler efficacement la réponse inflammatoire et raccourcir la durée de la prise en charge et du traitement.

Background Multi-organ dysfunction syndrome and multi-organ failure are the leading causes of late death in patients sustaining severe blunt trauma. So far, there is no established protocol to mitigate these sequelae. This study assessed the effect of hemoperfusion using resin-hemoadsorption 330 (HA330) cartridges on mortality and complications such as acute respiratory distress syndrome (ARDS) and systemic inflammatory response syndrome (SIRS) among such patients. Methods This quasi-experimental study recruited patients ≥ 15 years of age with blunt trauma, injury severity score (ISS) ≥ 15, or initial clinical presentation consistent with SIRS. They were divided into two groups: the Control group received only conventional acute care, while the case group received adjunctive hemoperfusion. P-values less than 0.05 were statistically significant. Results Twenty-five patients were included (Control and Case groups: 13 and 12 patients). The presenting vital signs, demographic and injury-related features (except for thoracic injury severity) were similar (p > 0.05). The Case group experienced significantly more severe thoracic injuries than the Control group (Thoracic AIS, median [IQR]: 3 [2–4] vs. 2 [0–2], p = 0.01). Eleven and twelve patients in the Case group had ARDS and SIRS before the hemoperfusion, respectively, and these complications were decreased considerably after hemoperfusion. Meanwhile, the frequency of ARDS and SIRS did not decrease in the Control group. Hemoperfusion significantly reduced the mortality rate in the Case group compared to the Control group (three vs. nine patients, p = 0.027). Conclusions Adjunctive Hemoperfusion using an HA330 cartridge decreases morbidity and improves outcomes in patients suffering from severe blunt trauma.

To evaluate the effect of direct hemoperfusion with polymyxin B immobilized cartridge (DHP-PMX) on meropenem pharmacokinetics in critically ill patients with sepsis requiring continuous venovenous hemofiltration (CVVH). After intravenous infusion of 1 g meropenem over 3 h repeated every 8 h for at least 3 doses, 2 serial blood and ultrafiltration fluid samples were collected: one over a dose interval of meropenem with DHP-PMX therapy; and the other on the following day over a dose interval of meropenem with no DHP-PMX therapy. Meropenem concentrations were measured by high performance liquid chromatography. Pharmacokinetic parameters of meropenem and extraction ratio of DHP-PMX were calculated. Mean AUC0–8 of meropenem on DHP-PMX day was comparable to that of the DHP-PMX free day (285.2 ± 138.2 vs 297.8 ± 130.2 mg ∗ h/L; paired t-test, p = .618). No statistical significance of peak and trough concentrations, volume of distribution, sieving coefficient, or half-life were found. Extraction ratio of DHP-PMX on meropenem was 0 [0–0.03] and clearance by DHP-PMX was 0.04 [0–0.2] L/h which was not considered clinically significant. No significant effect of DHP-PMX on meropenem pharmacokinetics was observed among severe sepsis/septic shock patients during CVVH treatment. Clinical Trial Registry detail: NCT registry: 02413541 (First registered March 3, 2015, last update October 16, 2017). •Polymyxin B-immobilized cartridge may adsorb some antibiotics.•Appropriate antibiotics with optimal dosages are required for sepsis management.•DHP-PMX do not exhibit a significant effect on meropenem pharmacokinetics.•Dose adjustment is not required for DHP-PMX.