COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

July 5, 2012 updated by: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of CPFA (Coupled Plasma Filtration Adsorption) for Septic Shock in the ICU

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Coupled Plasma Filtration Adsorption
No Intervention: 2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
At the discharge from the latest hospital

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mortality within 90 days from randomization
Time Frame: 90 days from randomization
90 days from randomization
New organ failures (assessed through SOFA score)
Time Frame: Within ICU stay
Within ICU stay
Days not spent in the ICU during the first 30 days from randomization
Time Frame: 30 days from randomization
30 days from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BELLCO S.r.l., Mirandola (MO), ITALY

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sergio Livigni, MD, Ospedale San Giovanni Bosco, Torino, ITALY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4817
  • ISRCTN24534559

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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