Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability in Post-resuscitation Shock (Hyperdia)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Gambro Industries, MEYZIEU, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00780299
First received: October 24, 2008
Last updated: August 1, 2013
Last verified: July 2013
  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 plasma epuration of inflammatory mediators (HDHP) 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: hemodialysis with high permeability (HDHP)
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 an Hemodialysis Treatment With High Permeability (HDHP) During the Early Period of Post-resuscitation Shock

Resource links provided by NLM:


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 HDHP Impact of HDHP on inflammatory parameters. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: October 2008
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (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
HDHP
Device: hemodialysis with high permeability (HDHP)
HDHP (hemodialysis with high permeability) is a specific plasma epuration of inflammatory mediators

Detailed Description:

HDHP (plasma epuration of inflammatory mediators) will be used in addition to the current clinical practice. The experimental arm will be treated by HDHP device.

The high permeability membrane SepteX is a membrane polyarylethersulfone sold by Gambro that allows the purification of molecules of average size to near 50 kd molecular weight.

We can thus purify molecules larger molecular weight than hemofiltration can with the usual membranes (30 kd). Furthermore, this increase in permeability allows a significant treatment medium-sized molecules in diffusion (hemodialysis), that the usual membranes do not allow. Finally, it is possible to purify certain molecules that hemofiltration including high volume does not allow (TNFalpha for example).

Use of this membrane requires the use of specific set dedicated machine Prismaflex itself with a specific software (Exceed) to ensure the control and security of processing.

2 sessions of HDHP will be performed in the first 48 hours following ICU admission ((with inclusion in the first 6 hours).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Laurence Lecomte, PhD +33(0)1 58 41 35 45 laurence.lecomte@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
Gambro Industries, MEYZIEU, France
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: August 1, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Plasma epuration
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 August 28, 2014