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

Primary Purpose

Cardiac Arrest, Sudden Cardiac Death, Shock

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
hemodialysis with high permeability (HDHP)
CVVH
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Plasma epuration, Hemofiltration, Cardiac arrest, Shock, Inflammatory mediators

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical intensive care unit of Cochin-St Vincent de Paul university Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2

1

Arm Description

control

HDHP

Outcomes

Primary Outcome Measures

The main endpoint will be the duration of the shock expressed by the length of catecholamine infusion

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.

Full Information

First Posted
October 24, 2008
Last Updated
April 30, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Gambro Industries, MEYZIEU, France
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1. Study Identification

Unique Protocol Identification Number
NCT00780299
Brief Title
Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability in Post-resuscitation Shock
Acronym
Hyperdia
Official Title
Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability (HDHP) During the Early Period of Post-resuscitation Shock
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 2, 2008 (Actual)
Primary Completion Date
January 2, 2016 (Actual)
Study Completion Date
January 2, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Gambro Industries, MEYZIEU, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Sudden Cardiac Death, Shock
Keywords
Plasma epuration, Hemofiltration, Cardiac arrest, Shock, Inflammatory mediators

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
control
Arm Title
1
Arm Type
Experimental
Arm Description
HDHP
Intervention Type
Device
Intervention Name(s)
hemodialysis with high permeability (HDHP)
Intervention Description
HDHP (hemodialysis with high permeability) is a specific plasma epuration of inflammatory mediators
Intervention Type
Procedure
Intervention Name(s)
CVVH
Intervention Description
hemofiltration intermittent dialysis
Primary Outcome Measure Information:
Title
The main endpoint will be the duration of the shock expressed by the length of catecholamine infusion
Time Frame
28 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Cariou, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical intensive care unit of Cochin-St Vincent de Paul university Hospital
City
Paris
ZIP/Postal Code
75679
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30974188
Citation
Geri G, Grimaldi D, Seguin T, Lamhaut L, Marin N, Chiche JD, Pene F, Bougle A, Daviaud F, Morichau-Beauchant T, Arnaout M, Champigneulle B, Zafrani L, Bourcier S, Nguyen YL, Charpentier J, Mira JP, Coste J, Vinsonneau C, Cariou A. Hemodynamic efficiency of hemodialysis treatment with high cut-off membrane during the early period of post-resuscitation shock: The HYPERDIA trial. Resuscitation. 2019 Jul;140:170-177. doi: 10.1016/j.resuscitation.2019.03.045. Epub 2019 Apr 8.
Results Reference
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Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability in Post-resuscitation Shock

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