COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

Sponsor

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Other)

Overall Status

Terminated

CT.gov ID

NCT00332371

Collaborator

BELLCO S.r.l., Mirandola (MO), ITALY (Other)

184

Enrollment

Locations

Arms

Duration (Months)

9.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Shock, Septic	Device: CPFA (Coupled Plasma Filtration Adsorption)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

184 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Device: CPFA (Coupled Plasma Filtration Adsorption) CPFA is a specific method for the treatment of sepsis. It consists of: a plasma-filter (polyethersulfone 0.45 m2 with a cutoff of approx 800 kDa) a hemofilter (polyethersulfone 1,4 m2) a cartridge (contains approximately 140 ml of hydrophobic styrenic resin) 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 Names: Coupled Plasma Filtration Adsorption
No Intervention: 2

Arm

Intervention/Treatment

Experimental: 1

Device: CPFA (Coupled Plasma Filtration Adsorption)

CPFA is a specific method for the treatment of sepsis. It consists of: a plasma-filter (polyethersulfone 0.45 m2 with a cutoff of approx 800 kDa) a hemofilter (polyethersulfone 1,4 m2) a cartridge (contains approximately 140 ml of hydrophobic styrenic resin) 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 Names:

Coupled Plasma Filtration Adsorption

No Intervention: 2

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Ospedale SS. Antonio e Biagio e C. Arrigo	Alessandria	AL	Italy	15100
2	Ospedale Regionale della Valle d'Aosta, Servizio Anestesia e Rianimazione	Aosta	AO	Italy	11100
3	Ospedali Riuniti, I Servizio Anestesia e Rianimazione	Bergamo	BG	Italy	24128
4	Ospedale Policlinico San Pietro, Servizio Anestesia e Rianimazione	Ponte San Pietro	BG	Italy	24036
5	Ospedale Policlinico San Marco, Terapia Intensiva	Zingonia	BG	Italy	24040
6	Ospedale Spedali Civili, II Servizio di Anestesia e Rianimazione	Brescia	BS	Italy	25125
7	Ospedale Vittorio Emanuele, II Servizio di Anestesia e Rianimazione	Catania	CT	Italy	95100
8	Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione	Forlì	FC	Italy	47100
9	Ospedale Careggi - Villa Monna Tessa, TI Polifunzionale e Post-trapianto	Firenze	FI	Italy	50134
10	Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione	Firenze	FI	Italy	50143
11	Ospedale Civile	Imperia	IM	Italy	18100
12	Ospedale Civile, Servizio Anestesia e Rianimazione	Sanremo	IM	Italy	18038
13	Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1	Lecco	LC	Italy	23900
14	Ospedale Madonna delle Grazie, U.O. Anestesia e Rianimazione	Matera	MT	Italy	75100
15	Ospedale di S. Chiara, VI U.O. di Anestesia, Rianimazione e Pronto Soccorso	Pisa	PI	Italy	56100
16	European Hospital	Roma	RM	Italy	00149
17	Ospedale San Camillo Forlanini	Roma	RM	Italy	00152
18	Ospedale Civile Regione Piemonte ASL 9, Servizio Anestesia e Rianimazione	Ivrea	TO	Italy	10015
19	Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA	Torino	TO	Italy	10148