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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-02

Study Completion Date

2016-01-02

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Cardiac Arrest Sudden Cardiac Death Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2

control

Group Type ACTIVE_COMPARATOR

CVVH

Intervention Type PROCEDURE

hemofiltration intermittent dialysis

1

HDHP

Group Type EXPERIMENTAL

hemodialysis with high permeability (HDHP)

Intervention Type DEVICE

HDHP (hemodialysis with high permeability) is a specific plasma epuration of inflammatory mediators

Interventions

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hemodialysis with high permeability (HDHP)

HDHP (hemodialysis with high permeability) is a specific plasma epuration of inflammatory mediators

Intervention Type DEVICE

CVVH

hemofiltration intermittent dialysis

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No