COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Shock, Septic |
Device: CPFA (Coupled Plasma Filtration Adsorption) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of CPFA (Coupled Plasma Filtration Adsorption) for Septic Shock in the ICU |
- 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) [ Time Frame: At the discharge from the latest hospital ] [ Designated as safety issue: Yes ]
- Mortality within 90 days from randomization [ Time Frame: 90 days from randomization ] [ Designated as safety issue: Yes ]
- New organ failures (assessed through SOFA score) [ Time Frame: Within ICU stay ] [ Designated as safety issue: Yes ]
- Days not spent in the ICU during the first 30 days from randomization [ Time Frame: 30 days from randomization ] [ Designated as safety issue: Yes ]
| Enrollment: | 184 |
| Study Start Date: | December 2006 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Device: CPFA (Coupled Plasma Filtration Adsorption)
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. Other Name: Coupled Plasma Filtration Adsorption
|
| No Intervention: 2 |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- Cardiopulmonary resuscitation
- Cerebral coma
- Metastatic cancer
- Presence of relative or absolute contraindications to CPFA
- Estimated life expectancy less than 2 weeks
- Already included in the study
- Admission from an other ICU where the patient remained for more than 24 hours
- Absence of informed consent
Contacts and Locations| Italy | |
| Ospedale SS. Antonio e Biagio e C. Arrigo | |
| Alessandria, AL, Italy, 15100 | |
| Ospedale Regionale della Valle d'Aosta, Servizio Anestesia e Rianimazione | |
| Aosta, AO, Italy, 11100 | |
| Ospedali Riuniti, I Servizio Anestesia e Rianimazione | |
| Bergamo, BG, Italy, 24128 | |
| Ospedale Policlinico San Pietro, Servizio Anestesia e Rianimazione | |
| Ponte San Pietro, BG, Italy, 24036 | |
| Ospedale Policlinico San Marco, Terapia Intensiva | |
| Zingonia, BG, Italy, 24040 | |
| Ospedale Spedali Civili, II Servizio di Anestesia e Rianimazione | |
| Brescia, BS, Italy, 25125 | |
| Ospedale Vittorio Emanuele, II Servizio di Anestesia e Rianimazione | |
| Catania, CT, Italy, 95100 | |
| Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione | |
| Forlì, FC, Italy, 47100 | |
| Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione | |
| Firenze, FI, Italy, 50143 | |
| Ospedale Careggi - Villa Monna Tessa, TI Polifunzionale e Post-trapianto | |
| Firenze, FI, Italy, 50134 | |
| Ospedale Civile | |
| Imperia, IM, Italy, 18100 | |
| Ospedale Civile, Servizio Anestesia e Rianimazione | |
| Sanremo, IM, Italy, 18038 | |
| Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1 | |
| Lecco, LC, Italy, 23900 | |
| Ospedale Madonna delle Grazie, U.O. Anestesia e Rianimazione | |
| Matera, MT, Italy, 75100 | |
| Ospedale di S. Chiara, VI U.O. di Anestesia, Rianimazione e Pronto Soccorso | |
| Pisa, PI, Italy, 56100 | |
| European Hospital | |
| Roma, RM, Italy, 00149 | |
| Ospedale San Camillo Forlanini | |
| Roma, RM, Italy, 00152 | |
| Ospedale Civile Regione Piemonte ASL 9, Servizio Anestesia e Rianimazione | |
| Ivrea, TO, Italy, 10015 | |
| Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA | |
| Torino, TO, Italy, 10148 | |
| Principal Investigator: | Sergio Livigni, MD | Ospedale San Giovanni Bosco, Torino, ITALY |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva |
| ClinicalTrials.gov Identifier: | NCT00332371 History of Changes |
| Other Study ID Numbers: | 4817, ISRCTN24534559 |
| Study First Received: | May 31, 2006 |
| Last Updated: | July 5, 2012 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva:
|
Intensive Care Shock, Septic Adsorption Sorption Detoxification |
Additional relevant MeSH terms:
|
Shock Shock, Septic Pathologic Processes Sepsis |
Infection Systemic Inflammatory Response Syndrome Inflammation |
ClinicalTrials.gov processed this record on May 16, 2013