COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

Not Applicable

Terminated

• Conditions: Shock, Septic
• Interventions: Device: CPFA (Coupled Plasma Filtration Adsorption)

• Registration Number: NCT00332371
• Lead Sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Brief Summary

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).

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.

Study Timeline

• Study First Submitted: 2006-05-31
• Study First Submitted QC: 2006-05-31
• Study First Posted: 2006-06-01
• Study Start: 2006-12
• Primary Completion: 2010-12
• Study Completion: 2011-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-05
• Last Update Posted: 2012-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CPFA (Coupled Plasma Filtration Adsorption)	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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	30 days from randomization

Trial Locations

Locations (19)

Ospedale Regionale della Valle d'Aosta, Servizio Anestesia e Rianimazione; 🇮🇹 Aosta, AO, Italy

Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione; 🇮🇹 Forlì, FC, Italy

Ospedali Riuniti, I Servizio Anestesia e Rianimazione; 🇮🇹 Bergamo, BG, Italy

Ospedale Spedali Civili, II Servizio di Anestesia e Rianimazione; 🇮🇹 Brescia, BS, Italy

Ospedale Policlinico San Pietro, Servizio Anestesia e Rianimazione; 🇮🇹 Ponte San Pietro, BG, Italy

Ospedale Vittorio Emanuele, II Servizio di Anestesia e Rianimazione; 🇮🇹 Catania, CT, Italy

Ospedale Careggi - Villa Monna Tessa, TI Polifunzionale e Post-trapianto; 🇮🇹 Firenze, FI, Italy

Ospedale Civile; 🇮🇹 Imperia, IM, Italy

Ospedale Madonna delle Grazie, U.O. Anestesia e Rianimazione; 🇮🇹 Matera, MT, Italy

Ospedale SS. Antonio e Biagio e C. Arrigo; 🇮🇹 Alessandria, AL, Italy

Ospedale Policlinico San Marco, Terapia Intensiva; 🇮🇹 Zingonia, BG, Italy

Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione; 🇮🇹 Firenze, FI, Italy

Ospedale Civile, Servizio Anestesia e Rianimazione; 🇮🇹 Sanremo, IM, Italy

Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1; 🇮🇹 Lecco, LC, Italy

Ospedale Civile Regione Piemonte ASL 9, Servizio Anestesia e Rianimazione; 🇮🇹 Ivrea, TO, Italy

Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA; 🇮🇹 Torino, TO, Italy

Ospedale San Camillo Forlanini; 🇮🇹 Roma, RM, Italy

European Hospital; 🇮🇹 Roma, RM, Italy

Ospedale di S. Chiara, VI U.O. di Anestesia, Rianimazione e Pronto Soccorso; 🇮🇹 Pisa, PI, Italy