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

Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability (HDHP) During the Early Period of Post-resuscitation Shock

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00780299
Acronym
Hyperdia
Enrollment
38
Registered
2008-10-27
Start date
2008-11-02
Completion date
2016-01-02
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Sudden Cardiac Death, Shock

Keywords

Plasma epuration, Hemofiltration, Cardiac arrest, Shock, Inflammatory mediators

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).

Interventions

DEVICEhemodialysis with high permeability (HDHP)

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

PROCEDURECVVH

hemofiltration intermittent dialysis

Sponsors

Gambro Industries, MEYZIEU, France
CollaboratorUNKNOWN
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The main endpoint will be the duration of the shock expressed by the length of catecholamine infusion28 days

Secondary

MeasureTime frame
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.28 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026