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COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00332371
Recruitment Status : Terminated (The study was prematurely interrupted for futility.)
First Posted : June 1, 2006
Last Update Posted : July 9, 2012
Sponsor:
Collaborator:
BELLCO S.r.l., Mirandola (MO), ITALY
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Shock, Septic Device: CPFA (Coupled Plasma Filtration Adsorption) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Mortality within 90 days from randomization [ Time Frame: 90 days from randomization ]
  2. New organ failures (assessed through SOFA score) [ Time Frame: Within ICU stay ]
  3. Days not spent in the ICU during the first 30 days from randomization [ Time Frame: 30 days from randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332371


Locations
Show Show 19 study locations
Sponsors and Collaborators
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
BELLCO S.r.l., Mirandola (MO), ITALY
Investigators
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Principal Investigator: Sergio Livigni, MD Ospedale San Giovanni Bosco, Torino, ITALY

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
ClinicalTrials.gov Identifier: NCT00332371    
Other Study ID Numbers: 4817
ISRCTN24534559
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012
Keywords provided by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva:
Intensive Care
Shock, Septic
Adsorption
Sorption Detoxification
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation