title: Mortality Reduction in Septic Shock by Plasma Adsorption (ROMPA): a protocol for a randomised clinical trial.
abstract: 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  NCT02357433; Pre-results.
authors.affiliation: Department of Clinical Medicine, Miguel Hernández University, San Juan de Alicante, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Colomina-Climent
authors.affiliation: Intensive Care Unit, Vega Baja Hospital of Orihuela, Orihuela, Spain.
authors.forename: Carola
authors.initials: C
authors.lastname: Giménez-Esparza
authors.affiliation: Intensive Care Unit, Vega Baja Hospital of Orihuela, Orihuela, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Portillo-Requena
authors.affiliation: Intensive Care Unit, General University Santa Lucía Hospital of Cartagena, Cartagena, Spain.
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Allegue-Gallego
authors.affiliation: Intensive Care Unit, General University Santa Lucía Hospital of Cartagena, Cartagena, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Galindo-Martínez
authors.affiliation: Intensive Care Unit, University Hospital of San Juan de Alicante, San Juan de Alicante, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Mollà-Jiménez
authors.affiliation: Intensive Care Unit, University Hospital of San Juan de Alicante, San Juan de Alicante, Spain.
authors.forename: José Luis
authors.initials: JL
authors.lastname: Antón-Pascual
authors.affiliation: Intensive Care Unit, Lluís Alcanyís Hospital of Xàtiva, Xàtiva, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Rodríguez-Serra
authors.affiliation: Intensive Care Unit, Lluís Alcanyís Hospital of Xàtiva, Xàtiva, Spain.
authors.forename: José Luis
authors.initials: JL
authors.lastname: Martín-Ruíz
authors.affiliation: Intensive Care Unit, Marina Baixa Hospital of Villajoyosa, Villajoyosa, Spain.
authors.forename: Pablo Juan
authors.initials: PJ
authors.lastname: Fernández-Arroyo
authors.affiliation: Intensive Care Unit, Marina Baixa Hospital of Villajoyosa, Villajoyosa, Spain.
authors.forename: Eugenia María
authors.initials: EM
authors.lastname: Blasco-Císcar
authors.affiliation: Intensive Care Unit, General University Hospital of Alicante, Alicante, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Cánovas-Robles
authors.affiliation: Intensive Care Unit, General University Hospital of Alicante, Alicante, Spain.
authors.forename: Miguel
authors.initials: M
authors.lastname: Herrera-Murillo
authors.affiliation: Intensive Care Unit, La Plana Hospital of Villarreal, Villarreal, Spain.
authors.forename: Enrique
authors.initials: E
authors.lastname: González-Hernández
authors.affiliation: Intensive Care Unit, La Plana Hospital of Villarreal, Villarreal, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Sánchez-Morán
authors.affiliation: Intensive Care Unit, Francesc de Borja Hospital of Gandía, Gandía, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Solera-Suárez
authors.affiliation: Intensive Care Unit, Francesc de Borja Hospital of Gandía, Gandía, Spain.
authors.forename: Jesús
authors.initials: J
authors.lastname: Torres-Tortajada
authors.affiliation: Intensive Care Unit, Vinalopó University Hospital of Elche, Elche, Spain.
authors.forename: José María
authors.initials: JM
authors.lastname: Nuñez-Martínez
authors.affiliation: Intensive Care Unit, Vinalopó University Hospital of Elche, Elche, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Martín-Langerwerf
authors.affiliation: Intensive Care Unit, University Hospital of Torrevieja, Torrevieja, Spain.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Herrero-Gutiérrez
authors.affiliation: Intensive Care Unit, University Hospital of Torrevieja, Torrevieja, Spain.
authors.forename: Isabel
authors.initials: I
authors.lastname: Sebastián-Muñoz
authors.affiliation: Department of Clinical Medicine, Miguel Hernández University, San Juan de Alicante, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Palazón-Bru
authors.affiliation: Department of Clinical Medicine, Miguel Hernández University, San Juan de Alicante, Spain.
authors.forename: Vicente Francisco
authors.initials: VF
authors.lastname: Gil-Guillén
mesh_terms: D000293:Adolescent; D000327:Adsorption; D000328:Adult; D016207:Cytokines; D005260:Female; D006440:Hemofiltration; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D012107:Research Design; D018805:Sepsis; D012720:Severity of Illness Index; D012772:Shock, Septic / Q000401:mortality / Q000628:therapy*; D013030:Spain
chemical_list: D016207:Cytokines
keywords: INFECTIOUS DISEASES; STATISTICS & RESEARCH METHODS