scholarly journals Effects of endotoxin adsorber hemoperfusion on sublingual microcirculation in patients with septic shock: a randomized controlled trial

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Shih-Hong Chen ◽  
Wing-Sum Chan ◽  
Chih-Min Liu ◽  
Ching-Tang Chiu ◽  
Anne Chao ◽  
...  
Keyword(s):  
Septic Shock ◽  
Controlled Trial ◽  
Polymyxin B ◽  
Vessel Density ◽  
Control Group ◽  
Sublingual Microcirculation ◽  
Norepinephrine Infusion ◽  
Risk Of Mortality ◽  
Protocol Registration ◽  
Sepsis And Septic Shock

Abstract Background Endotoxins can induce an excessive inflammatory response and result in microcirculatory dysfunction. Polymyxin-B hemoperfusion (PMX-HP) has been recognized to effectively remove endotoxins in patients with sepsis and septic shock, and a rat sepsis model revealed that PMX-HP treatment can maintain a better microcirculation. The primary aim of this study was to investigate the effect of PMX-HP on microcirculation in patients with septic shock. Methods Patients with septic shock were enrolled and randomized to control and PMX-HP groups. In the PMX-HP group, patients received the first session of PMX-HP in addition to conventional septic shock management within 24 h after the onset of septic shock; the second session of PMX-HP was provided after another 24 h as needed. Results Overall, 28 patients finished the trial and were analyzed. The mean arterial pressure and norepinephrine infusion dose did not differ significantly between the control and PMX-HP groups after PMX-HP treatment. At 48 h after enrollment, total vessel density (TVD) and perfused vessel density (PVD) were higher in the PMX-HP group than in the control group [TVD 24.2 (22.1–24.9) vs. 21.1 (19.9–22.9) mm/mm2; p = 0.007; PVD 22.9 (20.9–24.9) vs. 20.0 (18.9–21.6) mm/mm2, p = 0.008]. Conclusions This preliminary study observed that PMX-HP treatment improved microcirculation but not clinical outcomes in patients with septic shock at a low risk of mortality. Nevertheless, larger multicenter trials are needed to confirm the effect of PMX-HP treatment on microcirculation in patients with septic shock at intermediate- and high-risk of mortality. Trial registration ClinicalTrials.gov protocol registration ID: NCT01756755. Date of registration: December 27, 2012. First enrollment: October 6, 2013. https://clinicaltrials.gov/ct2/show/NCT01756755

scholarly journals Therapeutic Rationale for Endotoxin Removal with Polymyxin B Immobilized Fiber Column (PMX) for Septic Shock

2021 ◽  
Vol 22 (4) ◽  
pp. 2228
Author(s):  
Hisataka Shoji ◽  
Steven M. Opal
Keyword(s):  
Septic Shock ◽  
Organ Dysfunction ◽  
Survival Benefit ◽  
Controlled Trial ◽  
Antigen Expression ◽  
Polymyxin B ◽  
Term Survival ◽  
Surface Antigen Expression ◽  
Sepsis And Septic Shock

Endotoxin removal therapy with polymyxin B immobilized fiber column (PMX) has been clinically applied for sepsis and septic shock patients since 1994. The effectiveness and usefulness of this therapy have been demonstrated for more than a quarter of a century. However, a documented survival benefit has not yet been demonstrable in a large, multicenter, randomized and controlled trial. Following the findings derived from a large sepsis clinical trial with PMX in North America, a new trial is ongoing to determine if PMX has a long-term survival benefit when administered to septic patients. Another approach to support a survival benefit from intervention with PMX is to utilize a detailed analysis available from a large clinical data base. The endotoxin adsorption capacity of PMX columns in vitro and the effectiveness of PMX columns can be further demonstrable in animal models. The capability of PMX and details of its mechanism of action to intervene in the sepsis cascade and impede organ dysfunction in septic patients is not fully understood. The surface antigen expression in monocytes and neutrophils are improved after PMX therapy. Immunomodulatory effects as a result of endotoxin removal and/or other mechanisms of action have been suggested. These effects and other potential immune effects may explain some of the improved effects upon organ dysfunction of sepsis and septic shock patients. Endotoxemia may be involved in the pathophysiology of other diseases than sepsis. A rapid diagnostic method to detect and target endotoxemia could allow us to practice precision medicine and expand the clinical indications of endotoxin removal therapy.

scholarly journals Metabolic resuscitation therapy in critically Ill patients with sepsis and septic shock: A Prospective Randomized Controlled Trial

2021 ◽  
Author(s):  
Fang Feng ◽  
Huyong Yang ◽  
Weiwei Yang ◽  
Min Li ◽  
Yu Chen
Keyword(s):  
Septic Shock ◽  
Randomized Controlled Trial ◽  
Mortality Rate ◽  
Controlled Trial ◽  
Control Group ◽  
Icu Mortality ◽  
Randomized Controlled ◽  
Sepsis And Septic Shock ◽  
And Control ◽  
Experimental Group

Abstract ObjectiveTo further clarify the effectiveness and potential pathophysiological principles of metabolic resuscitation therapy in critically ill patients with sepsis and septic shock.MethodsProspective randomized controlled trial. Patients with sepsis and septic shock who were admitted to the ICU from Sep. 2019 to Mar. 2020 were prospectively enrolled. According to the computerized random sequence table, patients were randomly divided into the experimental group and the control group. All patients with sepsis were included in the research of cluster of initial therapy. The experimental group received metabolic resuscitation: vitamin C (1.5 g in an intravenous infusion q6h for 3 days), vitamin B1 (200 mg in an intramuscular injection q12h for 3 days), and hydrocortisone (50 mg in an intravenous infusion q6h for 7 days).ResultsOne hundred thirty-six patients with sepsis and septic shock were included in our study. Pneumonia was the main cause of sepsis and septic shock, including 33 (49%) and 41 (60%) patients in the experimental group and control group, respectively, and gram-negative bacilli were the main pathogenic bacteria (112/136, 82.4%). The ICU length of stay for the experimental group and the control group was 9 (7–12) and 11 (9–14) days, respectively, P = 0.002. The duration of vasoactive drugs (hours) was 20.8 ± 9.9 and 46.7 ± 12.8, respectively, P༜0.001. The 6-hour lactate clearance rate was 66.2% (55.5, 76.7) and 30.1% (15.6, 50) in the experimental group and control group, respectively, P = 0.000. The 72-hour PCT clearance rate was 70% (57.5, 80.3) and 40.7% (24.8, 52.2), respectively, P = 0.001. The ICU mortality rate was 8.8% (6/68) and 15% (15/68), respectively, P = 0.033.ConclusionsMetabolic resuscitation therapy is beneficial for patients with sepsis and septic shock, shortening the length of ICU stay, reducing the duration of vasopressor use, and reducing the ICU mortality rate of patients with sepsis and septic shock. However, large, multi-center, prospective randomized controlled trials are needed to further verify these results.Trial registrationChiCTR, ChiCTR1900026084. Registered 20 September 2019 - prospective registered, http://www.chictr.org.cn/edit.aspx?pid=40910&htm=4

scholarly journals Targeting skeletal muscle tissue oxygenation (StO2) in adults with severe sepsis and septic shock: a randomised controlled trial (OTO-StS Study)

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e017581 ◽  
Author(s):  
Olivier Nardi ◽  
Elizabeth Zavala ◽  
Claude Martin ◽  
Serafim Nanas ◽  
Thomas Scheeren ◽  
...  
Keyword(s):  
Skeletal Muscle ◽  
Septic Shock ◽  
Mechanical Ventilation ◽  
Severe Sepsis ◽  
Randomised Controlled Trial ◽  
Near Infrared ◽  
Controlled Trial ◽  
Control Group ◽  
Randomised Controlled ◽  
Sepsis And Septic Shock

ObjectiveEvaluation of the ratio of oxyhaemoglobin to total haemoglobin in skeletal muscle (StO2) using near-infrared spectroscopy may aid in the monitoring of patients with sepsis. This study assessed the benefits and risks of targeting StO2in adults with severe sepsis or septic shock.DesignA European randomised controlled trial was performed on two parallel groups.SettingFive intensive care units (ICU) in France, Greece, Spain and Germany were used for the study.ParticipantsA total of 103 adults with severe sepsis or septic shock on ICU admission were randomised (54 subjects in the experimental arm and 49 subjects in the control arm).InterventionsHaemodynamic management using an algorithm that was adapted from the 2004 Surviving Sepsis Campaign guidelines with (experimental arm) or without (control arm) targeting an StO2value greater than 80% at a minimum of two different sites.OutcomesThe primary outcome was a composite: 7-day all-cause mortality or worsening of organ function, defined as a positive difference in Sepsis-related Organ Failure Assessment (SOFA) score between day 7 and randomisation (ie, delta SOFA >0). Secondary endpoints: 30-day mortality, duration of mechanical ventilation and vasopressor therapy up to 30 days from randomisation.ResultsThe study ended prematurely due to lack of funding after enrolment of 103/190 patients. Eighteen patients (33.3%) in the experimental arm and 14 (28.6%, P=0.67) in the control arm died or exhibited delta SOFA >0 on day 7. The mean number of days on mechanical ventilation was 12.2±10.6 in the experimental group and 7.6±7.9 in the control group (P=0.03). Thirty-one (57%) patients in the experimental arm and 14 (29%) patients in the control arm received red cells by day 7 (P=0.01).ConclusionDespite the limitation related to premature termination, this study provides no data to support the routine implementation of resuscitation protocols incorporating StO2>80% at two or more muscle sites as a target. StO2-guided therapy may be associated with prolonged use of mechanical ventilation and an increased number of red blood cell transfusions.Trial registration numberNCT00167596; Results.

scholarly journals Effects of Polymyxin B Hemoperfusion on Septic Shock Patients Requiring Noradrenaline: Analysis of a Nationwide Administrative Database in Japan

2021 ◽  
pp. 1-6
Author(s):  
Kenji Fujimori ◽  
Kunio Tarasawa ◽  
Kiyohide Fushimi
Keyword(s):  
Septic Shock ◽  
Propensity Score ◽  
Propensity Score Matching ◽  
Polymyxin B ◽  
Administrative Database ◽  
Control Group ◽  
Continuous Hemodiafiltration ◽  
Significant Survival ◽  
Maximum Daily Dose ◽  
Polymyxin B Hemoperfusion

<b><i>Introduction:</i></b> Polymyxin B hemoperfusion (PMX) reduces endotoxin in septic shock patients’ blood and can improve hemodynamics and organ functions. However, its effects on the reduction of septic shock mortality are controversial. <b><i>Methods:</i></b> Using the Japanese diagnosis procedure combination database from April 2016 to March 2019, we identified adult septic shock patients treated with noradrenaline. This study used propensity score matching to compare the outcome between PMX-treated and non-treated patients. The primary endpoint was 28-day mortality, counting from the day of noradrenaline initiation. The secondary endpoints were noradrenaline-, ventilator-, and continuous hemodiafiltration (CHDF)-free days at day 28. <b><i>Results:</i></b> Of 30,731 eligible patients, 4,766 received PMX. Propensity score matching produced a matched cohort of 4,141 pairs with well-balanced patient backgrounds. The 28-day survival rate was 77.9% in the PMX group and 71.1% in the control group (<i>p</i> &#x3c; 0.0001). Median days of noradrenalin-, CHDF-, and ventilator-free days were 2 days (<i>p</i> &#x3c; 0.0001), 2 days (<i>p</i> &#x3c; 0.0001), and 6 days (<i>p</i> &#x3c; 0.0001) longer in the PMX group than in the control group, respectively. When stratified with the maximum daily dose of noradrenaline, the PMX group showed a statistically significant survival benefit in the groups with noradrenaline dose &#x3c;20 mg/day but not in the noradrenaline group dose ≥20 mg/day. <b><i>Conclusion:</i></b> Analysis of large Japanese databases showed that septic shock patients who received noradrenaline might benefit from PMX treatment.

scholarly journals Fluids in Sepsis and Septic Shock (FISSH): protocol for a pilot randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (7) ◽  
pp. e017602 ◽  
Author(s):  
Bram Rochwerg ◽  
Tina Millen ◽  
Peggy Austin ◽  
Michelle Zeller ◽  
Frédérick D’Aragon ◽  
...  
Keyword(s):  
Septic Shock ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled ◽  
Sepsis And Septic Shock

scholarly journals Is Presepsin a Reliable Marker of Sepsis Diagnosis in Pediatric Intensive Care Unit?

2020 ◽  
Vol 8 (B) ◽  
pp. 66-70
Author(s):  
Hebat-Allah Algebaly ◽  
Hala M. Fouad ◽  
Maha M. Elkholy ◽  
Sally K. Ibrahim ◽  
Nermin M. Riad
Keyword(s):  
Septic Shock ◽  
Severe Sepsis ◽  
Intensive Care ◽  
Consensus Conference ◽  
University Teaching ◽  
Control Group ◽  
Healthy Children ◽  
International Consensus ◽  
Critical Patients ◽  
Sepsis And Septic Shock

BACKGROUND: Sepsis is a major challenge in emergency departments and intensive care units (ICUs). Sepsis also mimics or interacts with many other disorders causing high mortality and morbidity. There is no accurate biomarker or test to diagnose or predict sepsis. The treatment of sepsis is often based on the clinician’s experience. AIM: We conducted this study to analyze the serum level of presepsin in pediatric critical patients with SIRS, sepsis, severe sepsis, and septic shock. METHODS: The study included 58 children, 32 septic pediatric patients admitted to the Pediatric ICU (PICU) of Cairo University Teaching Hospital and 26 healthy children who served as a control group. The aim was to estimate the diagnostic accuracy of presepsin in predicting sepsis in PICU. We classified the patients into systemic inflammatory response syndrome, sepsis, severe sepsis, and septic shock according to the international consensus conference criteria. RESULTS: In our study, we detected a positive correlation between C-reactive protein and presepsin levels at day 1 and day 3 of admission and a negative correlation between hemoglobin and presepsin levels at day 1. However, we found no difference in the serum presepsin between the children who had sepsis and the healthy ones (at day 1 [p = 0.430) and at day 3 [p = 0.845]). We also found that serum levels of presepsin were not significantly increased with the increasing severity of sepsis despite the higher median values with increasing sepsis severity. CONCLUSIONS: It was noted that presepsin levels increased in anemic critical patients, whereas presepsin had no role in differentiating the septic critical patients from healthy children. However, its level increased with increasing severity of sepsis grade.

Evaluation of red cell distribution width (RDW) as a septic marker in comparison with clinical scores and C-reactive protein

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Ali Ahmed Naga ◽  
Mohammed Ismaeil Abdel Fattah ◽  
Walid Hamed Nofal ◽  
Mohammed Abd-elsalam AlMenshawe
Keyword(s):  
Septic Shock ◽  
Severe Sepsis ◽  
Controlled Study ◽  
Control Group ◽  
Study Group ◽  
Distribution Width ◽  
Clinical Scores ◽  
Group I ◽  
Significant Difference ◽  
Sepsis And Septic Shock

Abstract Background Challenges of diagnosing and treating sepsis only seem more difficult as incidence increases, patients become older and sicker, and pathogenic organisms evolve. New understanding of inflammatory mediators and pathways, immunity, and genetic variability in this disease state suggests that the current definitions of SIRS, sepsis, severe sepsis, and septic shock are oversimplified. Objective The aim of our study is to evaluate the level of RDW, CRP and clinical scores "SOFA and APACHI" as markers in patients with sepsis and their levels on the outcome and resolution of sepsis in ICU. Methodology We conducted a prospective observational controlled study on 90 adult persons of both sex, 45 of them are adult patients and served as the study group (Group I), and the other 45 are healthy adult volunteers and served as the control group (Group II). The study group represented patients admitted to the ICU of Intensive Care Unit at Damanhour Medical National Institute who fulfilled the diagnostic criteria for sepsis, severe sepsis and septic shock on arrival to ICU according to the SCCM/ ESICM/ ACCP/ ATS/SIS International Sepsis Definitions Conference. Results. In the present study we found that CRP measured on admission was not a predictor of mortality, while that measured at day 5 and day 10 predicted mortality, where there was no statistically significant difference in CRP levels between survivors and non-survivors at the day of admission while there were statistically significant differences between survivors and non survivors according to CRP levels at day 5 (p = 0.001*) and at day 10 (p = 0.001*). It was found also that there were statistically significant differences between survivors and non-survivors according to RDW at day 1(p = 0.011*) and at day 5(p = 0.009*), at day 10 was found there was no statistically significant difference between survivors and non-survivors (p = 0.338). Conclusion RDW is a new promising cheap and readily available biomarker that can be able to diagnose patients with sepsis with accuracy comparable to CRP. Also, RDW at admission is able to predict mortality.

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