Hemodynamic Efficiency of CPFA in Post-Resuscitation Shock - Full Text View

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris BELLCO S.r.l., Mirandola (MO), ITALY
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00780299

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 III

MedlinePlus related topics: Cardiac Arrest

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Hemodynamic Efficiency of CPFA Therapy During the Early Period of Post-Resuscitation Shock

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:	October 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator control	Procedure: CVVH hemofiltration intermittent dialysis
1: Experimental 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).

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
Paris, France, 75679

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

Responsible Party:	Department Clinical Research of Developpement ( Saliha Djane )
Study ID Numbers:	P071005
Study First Received:	October 24, 2008
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00780299
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Plasma adsorption
Hemofiltration
Cardiac arrest
Shock
Inflammatory mediators

Study placed in the following topic categories:

Death
Heart Diseases
Shock

Death, Sudden
Heart Arrest
Death, Sudden, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009