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

Abstract

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-β=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.

DOI: 10.1136/bmjopen-2016-011856

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@inproceedings{ColominaCliment2016MortalityRI, title={Mortality Reduction in Septic Shock by Plasma Adsorption (ROMPA): a protocol for a randomised clinical trial}, author={Francisco Colomina-Climent and Carola Gim{\'e}nez-Esparza and Cristina Portillo-Requena and Jos{\'e} Manuel Allegue-Gallego and Mar{\'i}a Galindo-Mart{\'i}nez and Cristina Moll{\`a}-Jim{\'e}nez and Jos{\'e} Luis Ant{\'o}n-Pascual and Manuel Rodr{\'i}guez-Serra and Jos{\'e} Luis Mart{\'i}n-Ru{\'i}z and Pablo Juan Fern{\'a}ndez-Arroyo and Eugenia Mar{\'i}a Blasco-C{\'i}scar and Jos{\'e} C{\'a}novas-Robles and Miguel Herrera-Murillo and Enrique Gonz{\'a}lez-Hern{\'a}ndez and Fernando S{\'a}nchez-Mor{\'a}n and Manuel Solera-Su{\'a}rez and Jes{\'u}s Torres-Tortajada and Jos{\'e} N{\'u}{\~n}ez-Mart{\'i}nez and David Mart{\'i}n-Langerwerf and Eugenio Herrero-Guti{\'e}rrez and Isabel Sebasti{\'a}n-Mu{\~n}oz and Antonio Palaz{\'o}n-Bru and Vicente F. Gil-Guillen}, booktitle={BMJ open}, year={2016} }