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Circumstances beyond the course of the trial have produced a change in the conditions of recruitment unacceptable to the ROMPA researchers
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High doses CPFA | Experimental | High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization |
|
| Control Group | No Intervention | Standard practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Doses CPFA | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital mortality | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| time resolution of septic shock | normalization of lactate, and the decrease in vasoactive drugs | within the first 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Colomina, MD | Hospital Universitario de San Juan de Alicante | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Vinalopó | Elche | Alicante | 03293 | Spain | ||
| Hospital de la Vega Baja |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31796477 | Derived | 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. | |
| 27406647 |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| Orihuela |
| Alicante |
| 03300 |
| Spain |
| Hospital Universitario de San Juan de Alicante | Sant Joan d'Alacant | Alicante | 03550 | Spain |
| Hospital de Torrevieja | Torrevieja | Alicante | 03186 | Spain |
| Hospital Marina Baixa | Villajoyosa | Alicante | Spain |
| Hospital de la Plana | Villarreal | Castellon | 12540 | Spain |
| Hospital General Universitario de Santa Lucia | Cartagena | Murcia | 30202 | Spain |
| Hospital Frances De Borja de Gandia | Gandia | Valencia | Spain |
| Hospital Lluis Alcanyis | Xátiva | Valencia | 46800 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Derived |
| 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. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |