COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

Shock, Septic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00332371
• Other study ID #: 4817
• Secondary ID: ISRCTN24534559
• Status: Terminated
• Phase: N/A
• First received: May 31, 2006
• Last updated: July 5, 2012
• Start date: December 2006
• Est. completion date: July 2011

Study information

• Verified date: July 2012
• Source: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 184
• Est. completion date: July 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
Italy	Ospedale SS. Antonio e Biagio e C. Arrigo	Alessandria	AL
Italy	Ospedale Regionale della Valle d'Aosta, Servizio Anestesia e Rianimazione	Aosta	AO
Italy	Ospedali Riuniti, I Servizio Anestesia e Rianimazione	Bergamo	BG
Italy	Ospedale Spedali Civili, II Servizio di Anestesia e Rianimazione	Brescia	BS
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 S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione	Firenze	FI
Italy	Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione	Forlì	FC
Italy	Ospedale Civile	Imperia	IM
Italy	Ospedale Civile Regione Piemonte ASL 9, Servizio Anestesia e Rianimazione	Ivrea	TO
Italy	Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1	Lecco	LC
Italy	Ospedale Madonna delle Grazie, U.O. Anestesia e Rianimazione	Matera	MT
Italy	Ospedale di S. Chiara, VI U.O. di Anestesia, Rianimazione e Pronto Soccorso	Pisa	PI
Italy	Ospedale Policlinico San Pietro, Servizio Anestesia e Rianimazione	Ponte San Pietro	BG
Italy	European Hospital	Roma	RM
Italy	Ospedale San Camillo Forlanini	Roma	RM
Italy	Ospedale Civile, Servizio Anestesia e Rianimazione	Sanremo	IM
Italy	Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA	Torino	TO
Italy	Ospedale Policlinico San Marco, Terapia Intensiva	Zingonia	BG

Sponsors (2)

Lead Sponsor	Collaborator
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva	BELLCO S.r.l., Mirandola (MO), ITALY

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Mortality within 90 days from randomization		90 days from randomization	Yes
Secondary	New organ failures (assessed through SOFA score)		Within ICU stay	Yes
Secondary	Days not spent in the ICU during the first 30 days from randomization		30 days from randomization	Yes

External Links

•   GiViTI official web site