COMPACT 2 - COMbining Plasma-filtration and Adsorption Clinical Trial 2 (COMPACT-2)

September 2, 2021 updated by: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

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

The study objective is to clarify whether the application of high doses CPFA (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (ICU).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 high doses CPFA in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit. Secondary objectives are the resolution of septic shock and the reduction of ICU LOS (length of stay).

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • 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
    • Basilicata
      • Matera, Basilicata, Italy, 75100
        • Ospedale Madonna delle Grazie, U.O. di Anestesia e Rianimazione
    • Emilia Romagna
      • Cesena, Emilia Romagna, Italy, 47023
        • Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva
      • Forlì, Emilia Romagna, Italy, 47100
        • Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione
    • Lombardia
      • Lecco, Lombardia, Italy, 23900
        • Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
    • Piemonte
      • Alessandria, Piemonte, Italy, 15100
        • Ospedale SS. Antonio e Biagio e C. Arrigo, Servizio Anestesia, Rianimazione e Terapia Antalgica
      • Chieri, Piemonte, Italy, 10023
        • Ospedale Maggiore
      • Moncalieri, Piemonte, Italy, 10027
        • Ospedale Santa Croce
      • Torino, Piemonte, Italy, 10126
        • CTO Maria Adelaide, I Servizio Anestesia e Rianimazione
      • Torino, Piemonte, Italy, 10148
        • Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • AOU Careggi
      • Montepulciano, Toscana, Italy, 53045
        • Ospedali Riuniti Valdichiana Senese, U.O. di Anestesia e Rianimazione
      • Pescia, Toscana, Italy, 51017
        • Ospedale SS. Cosma e Damiano, Servizio Anestesia e Rianimazione
      • Poggibonsi, Toscana, Italy, 53036
        • Ospedale Alta Val d'Elsa, Terapia Intensiva

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

Ages Eligible for Study

12 years and older (Child, 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 14 years
  • Pregnancy
  • Estimated life expectancy (due to comorbidities) less than 90 days
  • Presence of relative or absolute contraindications to CPFA
  • 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
Intervention / Treatment
Experimental: High doses CPFA
High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization.
Device: High doses CPFA
High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization.
No Intervention: Control group
standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Mortality
Time Frame: At the discharge from the latest hospital (on average 30.3 days)
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 (on average 30.3 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality Within 90 Days From Randomization
Time Frame: 90 days from randomization
90 days from randomization
ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization
Time Frame: 30 days from randomization
30 days from randomization
Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization
Time Frame: 15 days from randomization
15 days from randomization

Collaborators and Investigators

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

Sponsor

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Collaborators

BELLCO Srl Mirandola (MO) ITALY

Investigators

  • 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

September 1, 2013

Primary Completion (Actual)

October 23, 2017

Study Completion (Actual)

October 23, 2017

Study Registration Dates

First Submitted

July 6, 2012

First Submitted That Met QC Criteria

July 10, 2012

First Posted (Estimate)

July 13, 2012

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6233

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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