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Hemodynamic Efficiency of CPFA in Post-resuscitation Shock (CPFA-ACR)

This study is currently recruiting participants.
Verified July 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
BELLCO S.r.l., Mirandola (MO), ITALY
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00780299
First received: October 24, 2008
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

Rationale: Despite spontaneous cardiac activity recovery, a shock occurs in more than half of patients after resuscitation for cardiac arrest. This acute circulatory insufficiency presents similar characteristics with septic shock and is responsible of most early deaths. Most frequently, usual treatments are unable to control this shock and to avoid the appearance of multiple organ failure.

Aim of the study: In addition to conventional therapeutics, an early inflammatory modulation by plasmatic adsorption (Coupled Plasma Filtration Adsorption or CPFA) could be able to improve hemodynamic parameters and to reduce the shock duration. This improvement could have an impact on multiple organ dysfunctions and also on early mortality.


Condition Intervention Phase
Cardiac Arrest
Sudden Cardiac Death
Shock
 Device: CPFA (Coupled Plasma Filtration Adsorption)
Procedure: CVVH
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hemodynamic Efficiency of CPFA Therapy During the Early Period of Post-resuscitation Shock

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The main endpoint will be the duration of the shock expressed by the length of catecholamine infusion [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in organ dysfunction score (SOFA, LOD) during the first 7 days Mortality at day 7 and day 28 Incidence of side effects and complications due to CPFA Impact of CPFA on inflammatory parameters. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: October 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
control
 Procedure: CVVH
hemofiltration intermittent dialysis
Other Name: CVVH
Experimental: 1
CPFA
 Device: CPFA (Coupled Plasma Filtration Adsorption)

CPFA is a specific method to remove inflammatory mediators. It consists of :

  • a plasma filter (polyethersulfone 0.45 m2 with a cutoff of 800 kDa
  • a hemofilter (polyethersulfone 1.4 m2
  • a cartridge (contains approximately 140 mL of hydrophobic sthenic resin) The kit is lodged in the BELLCO machine (BELLCO MIRANDOLA, Italy).
Other Name: CPFA (Coupled Plasma Filtration Adsorption)

Detailed Description:

CPFA (coupled plasma filtration adsorption) will be used in addition to the current clinical practice. The experimental arm will be treated by CPFA device. CPFA is a specific method to remove inflammatory mediators. It consists of :

a plasma filter (polyethersulfone 0.45 m2 with a cutoff of 800 kDa a hemofilter (polyethersulfone 1.4 m2 a cartridge (contains approximately 140 mL of hydrophobic sthenic resin) The kit is lodged in the BELLCO 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 hemofiltration step by way of a hemofilter.

2 sessions of CPFA (8 hours each) will be performed in the first 48 hours following ICU admission (first session immediately after inclusion).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Comatous patients admitted to the ICU for a sudden cardiac death apparently related to heart disease and requiring catecholamine infusion to treat a shock
  • Cardiac arrest in front of witnesses
  • Written informed consent obtained from the family or by emergency procedure

Exclusion criteria

  • Age under 18 years
  • Response to verbal commands (Glasgow score >7)
  • Terminal illness present before the cardiac arrest
  • Acquired or innate immune deficit
  • Anticoagulation not recommended or high hemorrhagic risk
  • pregnancy
  • weight > 100 kg
  • without social security
  • another clinical trial ongoing
  • cardiac arrest from non cardiac etiology
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780299

Contacts
Contact: Alain Cariou, MD, PhD +33(0)1 58 41 25 33 alain.cariou@cch.aphp.fr
Contact: Raphael Serreau, MD, PhD +33(0)158411180 raphael.serreau@cch.aphp.fr

Locations
France
Medical intensive care unit of Cochin-St Vincent de Paul university Hospital Recruiting
Paris, France, 75679
Principal Investigator: Alain Cariou, MD, PhD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
BELLCO S.r.l., Mirandola (MO), ITALY
Investigators
Principal Investigator: Alain Cariou, MD, PhD AP-HP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00780299     History of Changes
Other Study ID Numbers: P071005
Study First Received: October 24, 2008
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Plasma adsorption
Hemofiltration
Cardiac arrest
Shock
Inflammatory mediators

Additional relevant MeSH terms:
Heart Arrest
Shock
Death, Sudden, Cardiac
Death
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Death, Sudden

ClinicalTrials.gov processed this record on May 19, 2013