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

Primary Purpose

Shock, Septic

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High doses CPFA
Sponsored by
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock, Septic focused on measuring septic shock, intensive care medicine, coupled plasma filtration-adsorption

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Madonna delle Grazie, U.O. di Anestesia e Rianimazione
  • Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva
  • Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione
  • Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
  • Ospedale SS. Antonio e Biagio e C. Arrigo, Servizio Anestesia, Rianimazione e Terapia Antalgica
  • Ospedale Maggiore
  • Ospedale Santa Croce
  • CTO Maria Adelaide, I Servizio Anestesia e Rianimazione
  • Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
  • AOU Careggi
  • Ospedali Riuniti Valdichiana Senese, U.O. di Anestesia e Rianimazione
  • Ospedale SS. Cosma e Damiano, Servizio Anestesia e Rianimazione
  • Ospedale Alta Val d'Elsa, Terapia Intensiva

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High doses CPFA

Control group

Arm Description

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.

standard practice

Outcomes

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.

Secondary Outcome Measures

Mortality Within 90 Days From Randomization
ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization
Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization

Full Information

First Posted
July 6, 2012
Last Updated
September 2, 2021
Sponsor
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Collaborators
BELLCO Srl Mirandola (MO) ITALY
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1. Study Identification

Unique Protocol Identification Number
NCT01639664
Brief Title
COMPACT 2 - COMbining Plasma-filtration and Adsorption Clinical Trial 2
Acronym
COMPACT-2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
The interim analysis requested by the EDSMC shows higher mortality for the CPFA group compared to the controls, particularly in the first days of treatment.
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 23, 2017 (Actual)
Study Completion Date
October 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Collaborators
BELLCO Srl Mirandola (MO) ITALY

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Septic
Keywords
septic shock, intensive care medicine, coupled plasma filtration-adsorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High doses CPFA
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
standard practice
Intervention Type
Device
Intervention Name(s)
High doses CPFA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Mortality
Description
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 (on average 30.3 days)
Secondary Outcome Measure Information:
Title
Mortality Within 90 Days From Randomization
Time Frame
90 days from randomization
Title
ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization
Time Frame
30 days from randomization
Title
Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization
Time Frame
15 days from randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Livigni, MD
Organizational Affiliation
Ospedale San Giovanni Bosco, Torino, ITALY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Madonna delle Grazie, U.O. di Anestesia e Rianimazione
City
Matera
State/Province
Basilicata
ZIP/Postal Code
75100
Country
Italy
Facility Name
Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva
City
Cesena
State/Province
Emilia Romagna
ZIP/Postal Code
47023
Country
Italy
Facility Name
Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione
City
Forlì
State/Province
Emilia Romagna
ZIP/Postal Code
47100
Country
Italy
Facility Name
Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
City
Lecco
State/Province
Lombardia
ZIP/Postal Code
23900
Country
Italy
Facility Name
Ospedale SS. Antonio e Biagio e C. Arrigo, Servizio Anestesia, Rianimazione e Terapia Antalgica
City
Alessandria
State/Province
Piemonte
ZIP/Postal Code
15100
Country
Italy
Facility Name
Ospedale Maggiore
City
Chieri
State/Province
Piemonte
ZIP/Postal Code
10023
Country
Italy
Facility Name
Ospedale Santa Croce
City
Moncalieri
State/Province
Piemonte
ZIP/Postal Code
10027
Country
Italy
Facility Name
CTO Maria Adelaide, I Servizio Anestesia e Rianimazione
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10148
Country
Italy
Facility Name
AOU Careggi
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Ospedali Riuniti Valdichiana Senese, U.O. di Anestesia e Rianimazione
City
Montepulciano
State/Province
Toscana
ZIP/Postal Code
53045
Country
Italy
Facility Name
Ospedale SS. Cosma e Damiano, Servizio Anestesia e Rianimazione
City
Pescia
State/Province
Toscana
ZIP/Postal Code
51017
Country
Italy
Facility Name
Ospedale Alta Val d'Elsa, Terapia Intensiva
City
Poggibonsi
State/Province
Toscana
ZIP/Postal Code
53036
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
34601619
Citation
Garbero E, Livigni S, Ferrari F, Finazzi S, Langer M, Malacarne P, Meca MCC, Mosca S, Olivieri C, Pozzato M, Rossi C, Tavola M, Terzitta M, Viaggi B, Bertolini G; GiViTI. High dose coupled plasma filtration and adsorption in septic shock patients. Results of the COMPACT-2: a multicentre, adaptive, randomised clinical trial. Intensive Care Med. 2021 Nov;47(11):1303-1311. doi: 10.1007/s00134-021-06501-3. Epub 2021 Oct 3.
Results Reference
derived
PubMed Identifier
31157074
Citation
Milla P, Viterbo ML, Mosca S, Arpicco S. Chemical and microbiological stability, anticoagulant efficacy and toxicity of 35 and 90 mM trisodium citrate solutions stored in plastic syringes. Eur J Hosp Pharm. 2018 Oct;25(e2):e83-e87. doi: 10.1136/ejhpharm-2016-001094. Epub 2017 Jan 13.
Results Reference
derived
Links:
URL
http://www.giviti.marionegri.it
Description
GiViTI web site

Learn more about this trial

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

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