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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN24534559 |
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The study was prematurely interrupted for futility.
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| Name | Class |
|---|---|
| Bellco Srl Mirandola, Italy | INDUSTRY |
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The study objective is to clarify whether the application of CPFA (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce mortality and prevent organ failures in septic shock patients in intensive care unit (ICU).
Septic shock is a life-threatening clinical condition characterized by cardiovascular failure as a consequence of infection. Septic shock frequently causes multi-organ failure in the ICU. For this reason the extracorporeal therapies for the treatment of renal failure have become widespread in the ICU and, at the same time, new extracorporeal depurative techniques have been developed for the removal of inflammatory mediators. One of these techniques is CPFA (coupled plasma-filtration adsorption) that uses a sorbent once the separation between plasma and blood has been obtained with a plasma filter. The study objective is to clarify whether the application of CPFA in addition to the current clinical practice is able to reduce mortality and prevent organ failures in septic shock patients in intensive care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPFA (Coupled Plasma Filtration Adsorption) | Device | CPFA is a specific method for the treatment of sepsis. It consists of:
The kit is lodged in the Bellco "Lynda" machine (Bellco Mirandola, Italy). The treatment consists of the separation of plasma from the whole blood with adsorption of the inflammatory mediators and cytokines from the plasma, and a subsequent purification step by way of a hemofilter. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital mortality (for patients discharged to other hospital, it will be intended as mortality at the discharge from the latest hospital in which the patients stayed) | At the discharge from the latest hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality within 90 days from randomization | 90 days from randomization | |
| New organ failures (assessed through SOFA score) | Within ICU stay | |
| Days not spent in the ICU during the first 30 days from randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergio Livigni, MD | Ospedale San Giovanni Bosco, Torino, ITALY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale SS. Antonio e Biagio e C. Arrigo | Alessandria | AL | 15100 | Italy | ||
| Ospedale Regionale della Valle d'Aosta, Servizio Anestesia e Rianimazione |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24401721 | Derived | Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G; GiViTI: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Italian Group for the Evaluation of Interventions in Intensive Care Medicine) is an independent collaboration network of Italian Intensive Care units. Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: a multicenter randomised controlled clinical trial. BMJ Open. 2014 Jan 8;4(1):e003536. doi: 10.1136/bmjopen-2013-003536. |
| Label | URL |
|---|---|
| GiViTI official web site | View source |
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|
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| 30 days from randomization |
| Aosta |
| AO |
| 11100 |
| Italy |
| Ospedali Riuniti, I Servizio Anestesia e Rianimazione | Bergamo | BG | 24128 | Italy |
| Ospedale Policlinico San Pietro, Servizio Anestesia e Rianimazione | Ponte San Pietro | BG | 24036 | Italy |
| Ospedale Policlinico San Marco, Terapia Intensiva | Zingonia | BG | 24040 | Italy |
| Ospedale Spedali Civili, II Servizio di Anestesia e Rianimazione | Brescia | BS | 25125 | Italy |
| Ospedale Vittorio Emanuele, II Servizio di Anestesia e Rianimazione | Catania | CT | 95100 | Italy |
| Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione | Forlì | FC | 47100 | Italy |
| Ospedale Careggi - Villa Monna Tessa, TI Polifunzionale e Post-trapianto | Florence | FI | 50134 | Italy |
| Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione | Florence | FI | 50143 | Italy |
| Ospedale Civile | Imperia | IM | 18100 | Italy |
| Ospedale Civile, Servizio Anestesia e Rianimazione | Sanremo | IM | 18038 | Italy |
| Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1 | Lecco | LC | 23900 | Italy |
| Ospedale Madonna delle Grazie, U.O. Anestesia e Rianimazione | Matera | MT | 75100 | Italy |
| Ospedale di S. Chiara, VI U.O. di Anestesia, Rianimazione e Pronto Soccorso | Pisa | PI | 56100 | Italy |
| European Hospital | Roma | RM | 00149 | Italy |
| Ospedale San Camillo Forlanini | Roma | RM | 00152 | Italy |
| Ospedale Civile Regione Piemonte ASL 9, Servizio Anestesia e Rianimazione | Ivrea | TO | 10015 | Italy |
| Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA | Torino | TO | 10148 | Italy |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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