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

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ClinicalTrials.gov Identifier: NCT00780299
Recruitment Status : Active, not recruiting
First Posted : October 27, 2008
Last Update Posted : June 24, 2016
Sponsor:
Collaborator:
Gambro Industries, MEYZIEU, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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 or disease Intervention/treatment Phase
Cardiac Arrest Sudden Cardiac Death Shock Device: hemodialysis with high permeability (HDHP) Procedure: CVVH Phase 3

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 8 hours).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2008
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Shock
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 2
control
Procedure: CVVH
hemofiltration intermittent dialysis
Experimental: 1
HDHP
Device: hemodialysis with high permeability (HDHP)
HDHP (hemodialysis with high permeability) is a specific plasma epuration of inflammatory mediators



Primary Outcome Measures :
  1. The main endpoint will be the duration of the shock expressed by the length of catecholamine infusion [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780299


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
Gambro Industries, MEYZIEU, France
Investigators
Principal Investigator: Alain Cariou, MD, PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00780299     History of Changes
Other Study ID Numbers: P071005
First Posted: October 27, 2008    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016

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

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