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COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

NCT ID: NCT00332371

Last Updated: 2012-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2011-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Shock, Septic

Keywords

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Intensive Care Shock, Septic Adsorption Sorption Detoxification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

CPFA (Coupled Plasma Filtration Adsorption)

Intervention Type DEVICE

CPFA is a specific method for the treatment of sepsis.

It consists of:

1. a plasma-filter (polyethersulfone 0.45 m2 with a cutoff of approx 800 kDa)
2. a hemofilter (polyethersulfone 1,4 m2)
3. 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.

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CPFA (Coupled Plasma Filtration Adsorption)

CPFA is a specific method for the treatment of sepsis.

It consists of:

1. a plasma-filter (polyethersulfone 0.45 m2 with a cutoff of approx 800 kDa)
2. a hemofilter (polyethersulfone 1,4 m2)
3. 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.

Intervention Type DEVICE

Other Intervention Names

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Coupled Plasma Filtration Adsorption

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bellco Srl Mirandola, Italy

INDUSTRY

Sponsor Role collaborator

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergio Livigni, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Giovanni Bosco, Torino, ITALY

Locations

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Ospedale SS. Antonio e Biagio e C. Arrigo

Alessandria, AL, Italy

Site Status

Ospedale Regionale della Valle d'Aosta, Servizio Anestesia e Rianimazione

Aosta, AO, Italy

Site Status

Ospedali Riuniti, I Servizio Anestesia e Rianimazione

Bergamo, BG, Italy

Site Status

Ospedale Policlinico San Pietro, Servizio Anestesia e Rianimazione

Ponte San Pietro, BG, Italy

Site Status

Ospedale Policlinico San Marco, Terapia Intensiva

Zingonia, BG, Italy

Site Status

Ospedale Spedali Civili, II Servizio di Anestesia e Rianimazione

Brescia, BS, Italy

Site Status

Ospedale Vittorio Emanuele, II Servizio di Anestesia e Rianimazione

Catania, CT, Italy

Site Status

Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione

Forlì, FC, Italy

Site Status

Ospedale Careggi - Villa Monna Tessa, TI Polifunzionale e Post-trapianto

Florence, FI, Italy

Site Status

Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione

Florence, FI, Italy

Site Status

Ospedale Civile

Imperia, IM, Italy

Site Status

Ospedale Civile, Servizio Anestesia e Rianimazione

Sanremo, IM, Italy

Site Status

Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1

Lecco, LC, Italy

Site Status

Ospedale Madonna delle Grazie, U.O. Anestesia e Rianimazione

Matera, MT, Italy

Site Status

Ospedale di S. Chiara, VI U.O. di Anestesia, Rianimazione e Pronto Soccorso

Pisa, PI, Italy

Site Status

European Hospital

Roma, RM, Italy

Site Status

Ospedale San Camillo Forlanini

Roma, RM, Italy

Site Status

Ospedale Civile Regione Piemonte ASL 9, Servizio Anestesia e Rianimazione

Ivrea, TO, Italy

Site Status

Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA

Torino, TO, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 24401721 (View on PubMed)

Related Links

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http://www.giviti.marionegri.it

GiViTI official web site

Other Identifiers

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ISRCTN24534559

Identifier Type: -

Identifier Source: secondary_id

4817

Identifier Type: -

Identifier Source: org_study_id