Clinical trial NCT02357433: Mortality Reduction in Septic Shock by Plasma Adsorption
Official title: Reduccion de la Mortalidad Mediante Plasma-Adsorción en Shock séptico (ROMPA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Septic Shock
Lead sponsor: Hospital Universitario San Juan de Alicante
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study objective is to clarify whether the application of high doses CPFA (Coupled Plasma-Filtration Adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (ICU).


Eligibility criteria: Inclusion Criteria:

* all patients admitted to the ICU in septic shock
* all patients that develop septic shock while in the ICU

Exclusion Criteria:

* Age less than 18 years
* Pregnancy
* Estimated life expectancy (due to comorbidities) less than 90 days
* Presence of relative or absolute contraindications to CPFA
* Absence of informed consen

Primary outcomes:
measure: Hospital mortality
timeFrame: 28 days
Secondary outcomes:
measure: time resolution of septic shock
timeFrame: within the first 28 days
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital de Vinalopó
state: Alicante
city: Orihuela
country: Spain
facility: Hospital de la Vega Baja
state: Alicante
city: Sant Joan d'Alacant
country: Spain
facility: Hospital Universitario de San Juan de Alicante
state: Alicante
city: Torrevieja
country: Spain
facility: Hospital de Torrevieja
state: Alicante
city: Villajoyosa
country: Spain
facility: Hospital Marina Baixa
state: Alicante
city: Villarreal
country: Spain
facility: Hospital de la Plana
state: Castellon
city: Cartagena
country: Spain
facility: Hospital General Universitario de Santa Lucia
state: Murcia
city: Gandia
country: Spain
facility: Hospital Frances De Borja de Gandia
state: Valencia
city: Xátiva
country: Spain
facility: Hospital Lluis Alcanyis
state: Valencia
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
Study officials:
affiliation: Hospital Universitario de San Juan de Alicante
name: Francisco Colomina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gimenez-Esparza C, Portillo-Requena C, Colomina-Climent F, Allegue-Gallego JM, Galindo-Martinez M, Molla-Jimenez C, Anton-Pascual JL, Marmol-Peis E, Dolera-Moreno C, Rodriguez-Serra M, Martin-Ruiz JL, Fernandez-Arroyo PJ, Blasco-Ciscar EM, Canovas-Robles J, Gonzalez-Hernandez E, Sanchez-Moran F, Solera-Suarez M, Torres-Tortajada J, Palazon-Bru A, Gil-Guillen VF. The premature closure of ROMPA clinical trial: mortality reduction in septic shock by plasma adsorption. BMJ Open. 2019 Dec 3;9(12):e030139. doi: 10.1136/bmjopen-2019-030139.
citation: Colomina-Climent F, Gimenez-Esparza C, Portillo-Requena C, Allegue-Gallego JM, Galindo-Martinez M, Molla-Jimenez C, Anton-Pascual JL, Rodriguez-Serra M, Martin-Ruiz JL, Fernandez-Arroyo PJ, Blasco-Ciscar EM, Canovas-Robles J, Herrera-Murillo M, Gonzalez-Hernandez E, Sanchez-Moran F, Solera-Suarez M, Torres-Tortajada J, Nunez-Martinez JM, Martin-Langerwerf D, Herrero-Gutierrez E, Sebastian-Munoz I, Palazon-Bru A, Gil-Guillen VF. Mortality Reduction in Septic Shock by Plasma Adsorption (ROMPA): a protocol for a randomised clinical trial. BMJ Open. 2016 Jul 12;6(7):e011856. doi: 10.1136/bmjopen-2016-011856.