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Completed

NCT Number: NCT00780299

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Paris, 75679, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hemodialysis with high permeability (HDHP)

Device

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

CVVH

Procedure

hemofiltration intermittent dialysis

Primary outcomes

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

    Time frame: 28 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Gambro Industries, MEYZIEU, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: Hyperdia

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2008
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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