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COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

This study has been terminated.
(The study was prematurely interrupted for futility.)
Sponsor:
Collaborator:
BELLCO S.r.l., Mirandola (MO), ITALY
Information provided by (Responsible Party):
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
ClinicalTrials.gov Identifier:
NCT00332371
First received: May 31, 2006
Last updated: July 5, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva:

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) [ Time Frame: At the discharge from the latest hospital ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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:

  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.

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332371

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 Careggi - Villa Monna Tessa, TI Polifunzionale e Post-trapianto
Firenze, FI, Italy, 50134
Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione
Firenze, FI, Italy, 50143
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
Sponsors and Collaborators
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
BELLCO S.r.l., Mirandola (MO), ITALY
Investigators
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
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 25, 2014