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COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

Primary Purpose

Shock, Septic

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CPFA (Coupled Plasma Filtration Adsorption)
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 Intensive Care, Shock, Septic, Adsorption, Sorption Detoxification

Eligibility Criteria

18 Years - undefined (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 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

Sites / Locations

  • Ospedale SS. Antonio e Biagio e C. Arrigo
  • Ospedale Regionale della Valle d'Aosta, Servizio Anestesia e Rianimazione
  • Ospedali Riuniti, I Servizio Anestesia e Rianimazione
  • Ospedale Policlinico San Pietro, Servizio Anestesia e Rianimazione
  • Ospedale Policlinico San Marco, Terapia Intensiva
  • Ospedale Spedali Civili, II Servizio di Anestesia e Rianimazione
  • Ospedale Vittorio Emanuele, II Servizio di Anestesia e Rianimazione
  • Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione
  • Ospedale Careggi - Villa Monna Tessa, TI Polifunzionale e Post-trapianto
  • Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione
  • Ospedale Civile
  • Ospedale Civile, Servizio Anestesia e Rianimazione
  • Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
  • Ospedale Madonna delle Grazie, U.O. Anestesia e Rianimazione
  • Ospedale di S. Chiara, VI U.O. di Anestesia, Rianimazione e Pronto Soccorso
  • European Hospital
  • Ospedale San Camillo Forlanini
  • Ospedale Civile Regione Piemonte ASL 9, Servizio Anestesia e Rianimazione
  • Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

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
New organ failures (assessed through SOFA score)
Days not spent in the ICU during the first 30 days from randomization

Full Information

First Posted
May 31, 2006
Last Updated
July 5, 2012
Sponsor
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Collaborators
BELLCO S.r.l., Mirandola (MO), ITALY
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1. Study Identification

Unique Protocol Identification Number
NCT00332371
Brief Title
COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely interrupted for futility.
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
July 2011 (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 S.r.l., Mirandola (MO), ITALY

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Septic
Keywords
Intensive Care, Shock, Septic, Adsorption, Sorption Detoxification

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
CPFA (Coupled Plasma Filtration Adsorption)
Other Intervention Name(s)
Coupled Plasma Filtration Adsorption
Intervention Description
CPFA is a specific method for the treatment of sepsis. It consists of: a plasma-filter (polyethersulfone 0.45 m2 with a cutoff of approx 800 kDa) a hemofilter (polyethersulfone 1,4 m2) 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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Mortality within 90 days from randomization
Time Frame
90 days from randomization
Title
New organ failures (assessed through SOFA score)
Time Frame
Within ICU stay
Title
Days not spent in the ICU during the first 30 days from randomization
Time Frame
30 days from randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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 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
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 SS. Antonio e Biagio e C. Arrigo
City
Alessandria
State/Province
AL
ZIP/Postal Code
15100
Country
Italy
Facility Name
Ospedale Regionale della Valle d'Aosta, Servizio Anestesia e Rianimazione
City
Aosta
State/Province
AO
ZIP/Postal Code
11100
Country
Italy
Facility Name
Ospedali Riuniti, I Servizio Anestesia e Rianimazione
City
Bergamo
State/Province
BG
ZIP/Postal Code
24128
Country
Italy
Facility Name
Ospedale Policlinico San Pietro, Servizio Anestesia e Rianimazione
City
Ponte San Pietro
State/Province
BG
ZIP/Postal Code
24036
Country
Italy
Facility Name
Ospedale Policlinico San Marco, Terapia Intensiva
City
Zingonia
State/Province
BG
ZIP/Postal Code
24040
Country
Italy
Facility Name
Ospedale Spedali Civili, II Servizio di Anestesia e Rianimazione
City
Brescia
State/Province
BS
ZIP/Postal Code
25125
Country
Italy
Facility Name
Ospedale Vittorio Emanuele, II Servizio di Anestesia e Rianimazione
City
Catania
State/Province
CT
ZIP/Postal Code
95100
Country
Italy
Facility Name
Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione
City
Forlì
State/Province
FC
ZIP/Postal Code
47100
Country
Italy
Facility Name
Ospedale Careggi - Villa Monna Tessa, TI Polifunzionale e Post-trapianto
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Facility Name
Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione
City
Firenze
State/Province
FI
ZIP/Postal Code
50143
Country
Italy
Facility Name
Ospedale Civile
City
Imperia
State/Province
IM
ZIP/Postal Code
18100
Country
Italy
Facility Name
Ospedale Civile, Servizio Anestesia e Rianimazione
City
Sanremo
State/Province
IM
ZIP/Postal Code
18038
Country
Italy
Facility Name
Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
City
Lecco
State/Province
LC
ZIP/Postal Code
23900
Country
Italy
Facility Name
Ospedale Madonna delle Grazie, U.O. Anestesia e Rianimazione
City
Matera
State/Province
MT
ZIP/Postal Code
75100
Country
Italy
Facility Name
Ospedale di S. Chiara, VI U.O. di Anestesia, Rianimazione e Pronto Soccorso
City
Pisa
State/Province
PI
ZIP/Postal Code
56100
Country
Italy
Facility Name
European Hospital
City
Roma
State/Province
RM
ZIP/Postal Code
00149
Country
Italy
Facility Name
Ospedale San Camillo Forlanini
City
Roma
State/Province
RM
ZIP/Postal Code
00152
Country
Italy
Facility Name
Ospedale Civile Regione Piemonte ASL 9, Servizio Anestesia e Rianimazione
City
Ivrea
State/Province
TO
ZIP/Postal Code
10015
Country
Italy
Facility Name
Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
City
Torino
State/Province
TO
ZIP/Postal Code
10148
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24401721
Citation
Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G; GiViTI: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Italian Group for the Evaluation of Interventions in Intensive Care Medicine) is an independent collaboration network of Italian Intensive Care units. Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: a multicenter randomised controlled clinical trial. BMJ Open. 2014 Jan 8;4(1):e003536. doi: 10.1136/bmjopen-2013-003536.
Results Reference
derived
Links:
URL
http://www.giviti.marionegri.it
Description
GiViTI official web site

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COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

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