Mortality Reduction in Septic Shock by Plasma Adsorption (ROMPA): a protocol for a randomised clinical trial.

INTRODUCTION: There is a lack of evidence in the efficacy of the coupled plasma filtration adsorption (CPFA) to reduce the mortality rate in septic shock. To fill this gap, we have designed the ROMPA study (Mortality Reduction in Septic Shock by Plasma Adsorption) to confirm whether treatment with an adequate dose of treated plasma by CPFA could confer a clinical benefit. METHODS AND ANALYSIS: Our study is a multicentric randomised clinical trial with a 28-day and 90-day follow-up and allocation ratio 1:1. Its aim is to clarify whether the application of high doses of CPFA (treated plasma ≥0.20 L/kg/day) in the first 3 days after randomisation, in addition to the current clinical practice, is able to reduce hospital mortality in patients with septic shock in intensive care units (ICUs) at 28 and 90 days after initiation of the therapy. The study will be performed in 10 ICUs in the Southeast of Spain which follow the same protocol in this disease (based on the Surviving Sepsis Campaign). Our trial is designed to be able to demonstrate an absolute mortality reduction of 20% (α=0.05; 1-ß=0.8; n=190(95×2)). The severity of the process, ensuring the recruitment of patients with a high probability of death (50% in the control group), will be achieved through an adequate stratification by using both severity scores and classical definitions of severe sepsis/septic shock and dynamic parameters. Our centres are fully aware of the many pitfalls associated with previous medical device trials. Trying to reduce these problems, we have developed a training programme to improve the CPFA use (especially clotting problems). ETHICS AND DISSEMINATION: The protocol was approved by the Ethics Committees of all the participant centres. The findings of the trial will be disseminated through peer-reviewed journals, as well as national and international conference presentations. TRIAL REGISTRATION NUMBER: NCT02357433; Pre-results.

Miocarditis de células gigantes. Presentación de un caso autópsico / Giant cell myocarditis. Report of an autopsy case

La Miocarditis de Células Gigantes (MCG) es una miocardiopatíapoco frecuente, de posible causa inmunológica,con evolución fatal por fallo cardíaco congestivo, cuya principalterapia es el tratamiento inmunosupresor o el trasplante.El diagnóstico definitivo es histopatológico. El caso quese describe corresponde a una mujer de 59 años, que mostróun cuadro clínico de infarto agudo de miocardio, conimágenes de coronariografía normales, realizándose el diagnóstico«post-mortem» en la autopsia

Giant Cell Myocarditis is a rare myocardiopathy, withuncertain immunology basis, fatal evolution and congestiveheart failure. Its main treatment is immunosuppressive therapyor cardiac transplantation. The diagnosis is definitivelyhistopathological. The reported case corresponds to a 59years old woman, showing clinical findings of acute myocardiuminfarct but normal coronariography. The definitivediagnosis was made in the autopsy