scholarly journals Role of Plasmapheresis and Extracorporeal Membrane Oxygenation in the Treatment of Leptospirosis Complicated with Pulmonary Hemorrhages

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
C. L. Fonseka ◽  
S. Lekamwasam
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Extracorporeal Membrane Oxygenation ◽  
Study Design ◽  
Case Reports ◽  
Pulmonary Hemorrhage ◽  
Treatment Modalities ◽  
Current Evidence ◽  
Membrane Oxygenation ◽  
Severe Leptospirosis

Introduction. Leptospirosis is an emerging infectious disease associated with multiorgan involvement and significant morbidity and mortality. Although pulmonary hemorrhage due to leptospirosis has a high fatality, specific treatment options are limited and their efficacy is not adequately proven. We opted to find out the current evidence on plasmapheresis and extracorporeal membrane oxygenation (ECMO) in pulmonary hemorrhages due to leptospirosis. Methods. The first search was conducted in PubMed, OVID, Google Scholar, and Cochrane clinical trial registry using keywords “leptospirosis” OR “Leptospira” OR “Weil’s disease” AND “plasmapheresis” OR “plasma exchange” AND “pulmonary hemorrhage” OR “alveolar hemorrhage” OR “lung hemorrhage” and the second search was done using keyword “leptospirosis” OR “Leptospira” OR “Weil’s disease” AND “ECMO” OR “Extracorporeal membrane oxygenation.” The searches were not limited by study design or the date of publication. Only articles written in English were reviewed. Although we intended to include only clinical trials, it was decided later to include other information such as case reports and case series which addressed these treatment modalities. Two authors selected articles independently in a blinded manner using a set of inclusion and exclusion criteria and discrepancies were solved after discussions. Results. The information found was very limited. This included one clinical trial which showed a significant survival benefit with plasmapheresis but the study design had many limitations. Two case reports described the benefit of plasmapheresis in severe leptospirosis with pulmonary hemorrhages. There were eight case reports where ECMO was performed and out of all only one patient has died. One retrospective study on patients with severe leptospirosis mentioned that four out of five patients with pulmonary hemorrhages survived after being treated with ECMO. Conclusions. Current evidence is insufficient to recommend the routine use of plasmapheresis or ECMO for patients presenting with pulmonary hemorrhages due to leptospirosis. ECMO may be a promising mode of treatment in acute respiratory failure in leptospirosis related pulmonary hemorrhages. These treatment modalities, however, can be applied based on the availability of resources and expertise at the discretion of the clinician in charge, considering patient related factors such as cardiovascular stability and derangement of coagulation profile. Clinical trials conducted adhering to standard procedures are urgently required to establish the efficacy of these treatment modalities.

Extracorporeal Membrane Oxygenation and the Play the Winner Rule

PEDIATRICS ◽  
1985 ◽  
Vol 76 (4) ◽  
pp. 622-623
Author(s):  
NIGEL PANETH ◽  
SYLVAN WALLENSTEIN
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Extracorporeal Membrane Oxygenation ◽  
Randomized Clinical Trial ◽  
Conventional Treatment ◽  
Randomized Clinical Trials ◽  
Ethical Problem ◽  
Therapeutic Trial ◽  
Membrane Oxygenation ◽  
Treatment Comparisons

The therapeutic trial comparing extracorporeal membrane oxygenation with conventional treatment in neonatal respiratory failure reported by Bartlett et al (Pediatrics 1985;76:479-487) uses a method of comparing treatments unlikely to be familiar to most pediatricians. Known as the "randomized play the winner" method, it has thus far been little used in clinical research. Most clinical investigators consider the conventional randomized clinical trial to be the last word in treatment comparisons. But randomized clinical trials are costly, cumbersome, and to some observers less than ideal ethically. The ethical problem arises from the fact that during a "successful" randomized clinical trial (ie, one that demonstrates a significant advantage to one treatment) about half of the trial subjects will receive a treatment which, at the end of the trial, will be known to be inferior.

Continuous and Extended Infusions of β-Lactam Antibiotics in the Pediatric Population

2012 ◽  
Vol 46 (11) ◽  
pp. 1537-1546 ◽  
Author(s):  
Mary Covington Walker ◽  
Weng Man Lam ◽  
Kalen B Manasco
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Continuous Infusion ◽  
Pediatric Patients ◽  
Case Reports ◽  
Pediatric Population ◽  
Case Series ◽  
Current Evidence ◽  
Pharmacokinetic Studies ◽  
Randomized Controlled

OBJECTIVE: To conduct a systematic review of available data on the use of extended or continuous infusion of β-lactam and monobactam therapy in the pediatric population (aged 0–18 years). DATA SOURCES: A literature search was performed using PubMed (1975-May 2012), International Pharmaceutical Abstracts (1970-May 2012), and Web of Science (1977-May 2012) to identify studies for inclusion. In addition, reference citations from identified publications were reviewed. The following search terms were used: pediatric, children, neonate, infant, adolescent, β-lactam, cephalosporin, carbapenem, penicillin, monobactam, continuous infusion, extended infusion, and/or prolonged infusion. Individual names of drugs in each class of antibiotics were also included in the search. STUDY SELECTION AND DATA EXTRACTION: Randomized controlled clinical trials, pharmacokinetic/pharmacodynamic studies, observational studies, and case reports involving pediatric patients who received extended or continuous infusion of β-lactam or monobactam antibiotics were reviewed. Only English-language publications were included. DATA SYNTHESIS: One randomized controlled clinical trial, 5 pharmacokinetic studies, 2 pharmacodynamic studies using Monte Carlo simulation, 1 case series, and 7 case reports were included in the analysis. The cephalosporin class has been studied the most and currently represents the only clinical trial using a continuous infusion dosing strategy in pediatric patients. There is limited clinical evidence available to support the use of extended or continuous infusion of β-lactam antibiotics in the pediatric population. Pharmacodynamic studies conducted in this population mirror the current evidence in adults for cefepime and meropenem. The single prospective clinical trial using continuous infusion of ceftazidime failed to demonstrate any clinical benefit over traditional dosing; however, there was equal efficacy. CONCLUSIONS: More well-designed prospective clinical trials are required to determine the role of extended or continuous infusion of β-lactam antibiotics in treatment of pediatric patients.

scholarly journals Vitamin C in the Treatment of COVID-19

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1172
Author(s):  
Gregorio Paolo Milani ◽  
Marina Macchi ◽  
Anat Guz-Mark
Keyword(s):  
Clinical Trials ◽  
Vitamin C ◽  
Respiratory Infections ◽  
Medical Condition ◽  
Case Reports ◽  
Case Series ◽  
Theoretical Background ◽  
Current Evidence ◽  
Vitamin C Supplementation ◽  
Essential Nutrient

Vitamin C is an essential nutrient that serves as antioxidant and plays a major role as co-factor and modulator of various pathways of the immune system. Its therapeutic effect during infections has been a matter of debate, with conflicting results in studies of respiratory infections and in critically ill patients. This comprehensive review aimed to summarize the current evidence regarding the use of vitamin C in the prevention or treatment of patients with SARS-CoV2 infection, based on available publications between January 2020 and February 2021. Overall, 21 publications were included in this review, consisting of case-reports and case-series, observational studies, and some clinical trials. In many of the publications, data were incomplete, and in most clinical trials the results are still pending. No studies regarding prevention of COVID-19 with vitamin C supplementation were found. Although some clinical observations reported improved medical condition of patients with COVID-19 treated with vitamin C, available data from controlled studies are scarce and inconclusive. Based on the theoretical background presented in this article, and some preliminary encouraging studies, the role of vitamin C in the treatment of patients with SARS-CoV-2 infection should be further investigated.

Reducing Broad Spectrum Antimicrobial Use in Extracorporeal Membrane Oxygenation (ECMO): Reduce AMMO Study

2021 ◽  
Author(s):  
Aditya Shah ◽  
Priya Sampathkumar ◽  
Ryan W Stevens ◽  
John K Bohman ◽  
Brian D Lahr ◽  
...  
Keyword(s):  
Time Series ◽  
Extracorporeal Membrane Oxygenation ◽  
Broad Spectrum ◽  
Antimicrobial Prophylaxis ◽  
Current Evidence ◽  
Antimicrobial Use ◽  
Infection Rates ◽  
Interrupted Time Series Analysis ◽  
Membrane Oxygenation ◽  
The Impact

Abstract Background The use of extracorporeal membrane oxygenation (ECMO) in critically ill adults is increasing. There are currently no guidelines for antimicrobial prophylaxis. We analyzed 7 years of prophylactic antimicrobial use across three time series for patients on ECMO at our institution in the development, improvement, and streamlining of our ECMO antimicrobial prophylaxis protocol. Study design and Methods In this quasi-experimental interrupted time series analysis, we evaluated the impact of an initial ECMO antimicrobial prophylaxis protocol, implemented in 2014, on antimicrobial use and NHSN reportable infection rates. Then, following a revision and streamlining of the protocol in November 2018, we re-evaluated the same metrics. Results Our study population included 338 ICU patients who received ECMO between July 2011 and November 2019. After implementation of the first version of the protocol we did not observe significant changes in antimicrobial use or infection rates in these patients; however, following revision and streamlining of the protocol, we demonstrated a significant reduction in broad spectrum antimicrobial use for prophylaxis in patients on ECMO without any evidence of a compensatory increase in infection rates. Conclusion Our final protocol significantly reduces broad spectrum antimicrobial use for prophylaxis in patients on ECMO. We propose a standard antimicrobial prophylaxis regimen for patients on ECMO based on current evidence and our experience.

scholarly journals Canadian Recommendations for Clinical Trials of Pharmacologic Interventions in Rheumatoid Arthritis: Inclusion Criteria and Study Design: Table 1.

2011 ◽  
Vol 38 (10) ◽  
pp. 2095-2104 ◽  
Author(s):  
JACOB KARSH ◽  
EDWARD C. KEYSTONE ◽  
BOULOS HARAOUI ◽  
J. CARTER THORNE ◽  
JANET E. POPE ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Disease Activity ◽  
Study Design ◽  
New Drugs ◽  
Nominal Group ◽  
Consensus Method ◽  
Inclusion Criteria ◽  
Design Features

Objective.Current clinical trial designs for pharmacologic interventions in rheumatoid arthritis (RA) do not reflect the innovations in RA diagnosis, treatment, and care in countries where new drugs are most often used. The objective of this project was to recommend revised entry criteria and other study design features for RA clinical trials.Methods.Recommendations were developed using a modified nominal group consensus method. Canadian Rheumatology Research Consortium (CRRC) members were polled to rank the greatest challenges to clinical trial recruitment in their practices. Initial recommendations were developed by an expert panel of rheumatology trialists and other experts. A scoping study methodology was then used to examine the evidence available to support or refute each initial recommendation. The potential influence of CRRC recommendations on primary outcomes in future trials was examined. Recommendations were finalized using a consensus process.Results.Recommendations for clinical trial inclusion criteria addressed measures of disease activity [Disease Activity Score 28 using erythrocyte sedimentation rate (DAS28-ESR) > 3.2 PLUS ≥ 3 tender joints using 28-joint count (TJC28) PLUS ≥ 3 swollen joint (SJC28) OR C-reactive protein (CRP) or ESR > upper limit of normal PLUS ≥ 3 TJC28 PLUS ≥ 3 SJC28], functional classification, disease classification and duration, and concomitant RA treatments. Additional recommendations regarding study design addressed rescue strategies and longterm extension.Conclusion.There is an urgent need to modify clinical trial inclusion criteria and other study design features to better reflect the current characteristics of people living with RA in the countries where the new drugs will be used.

Inhaled Nitric Oxide Trials: "Vive la différence!"

PEDIATRICS ◽  
1996 ◽  
Vol 97 (3) ◽  
pp. 438-438
Author(s):  
DENNIS DAVIDSON
Keyword(s):  
Nitric Oxide ◽  
Clinical Trials ◽  
Pulmonary Hypertension ◽  
Optimal Design ◽  
Extracorporeal Membrane Oxygenation ◽  
Rescue Therapy ◽  
Underlying Disease ◽  
Inhaled Nitric Oxide ◽  
Persistent Pulmonary Hypertension ◽  
Membrane Oxygenation

The commentary by Drs Abman and Kinsella entitled "Inhaled Nitric Oxide for Persistent Pulmonary Hypertension of the Newborn: The Physiology Matters!" provides one important and valid viewpoint concerning the optimal design of clinical trials in this area of neonatology. The approach that they advocate involves individualized and meticulous care of persistent pulmonary hypertension of the newborn (PPHN) patients depending on their underlying disease, using whatever conventional or rescue therapy (before extracorporeal membrane oxygenation [ECMO] is needed to support the patient, while testing the efficacy of inhaled nitric oxide (I-NO).

scholarly journals Veno-venous extracorporeal membrane oxygenation successfully treated a case of severe pulmonary hemorrhage caused by leptospirosis

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
H. J. Wang ◽  
G. Z. Chen ◽  
C. J. Zhou ◽  
Y. FU ◽  
L. N. YAO
Keyword(s):  
Extracorporeal Membrane Oxygenation ◽  
Mainland China ◽  
Pulmonary Hemorrhage ◽  
Lavage Fluid ◽  
Case Presentation ◽  
Membrane Oxygenation ◽  
Second Generation Sequencing ◽  
Very High ◽  
Generation Sequencing ◽  
Secondary Condition

Abstract Background Pulmonary hemorrhage is an important complication of leptospirosis. Once acute respiratory distress syndrome (ARDS) occurs as a secondary condition, treatment is extremely difficult and the mortality rate is very high. Case presentation The patient was a 49-year-old. He was admitted to the hospital because he had experienced a fever and cough for 4 days. Hemorrhage, respiratory failure, ARDS and other symptoms appeared soon after admission. Due to severe pulmonary hemorrhage secondary to ARDS, mechanical ventilation was performed through tracheal intubation. During intubation, the patient suffered cardiac arrest, and the patient’s condition worsened. He was confirmed to have leptospirosis through second-generation sequencing of the alveolar lavage fluid. Finally, we successfully treated the patient with penicillin as an anti-infective medication and venous-venous extracorporeal membrane oxygenation (v-vECMO). To the best of our knowledge, this report is the first to describe the successful application of ECMO in mainland China. Conclusions Leptospirosis can induce serious but transient ARDS with a better prognosis than other causes of ARDS. Our patient was successfully treated with V-vECMO.

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