NCT00780299

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

November 2, 2008

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2016

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

7.2 years

First QC Date

October 24, 2008

Last Update Submit

September 1, 2025

Conditions

Cardiac ArrestSudden Cardiac DeathShock

Keywords

Plasma epurationHemofiltrationCardiac arrestShockInflammatory mediators

Outcome Measures

Primary Outcomes (1)

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

    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.

    28 days

Study Arms (2)

2

ACTIVE COMPARATOR

control

Procedure: CVVH

1

EXPERIMENTAL

HDHP

Device: hemodialysis with high permeability (HDHP)

Interventions

hemodialysis with high permeability (HDHP)DEVICE

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

1
CVVHPROCEDURE

hemofiltration intermittent dialysis

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Paris, 75679, France

Location

Related Publications (1)

  • 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.

    PMID: 30974188BACKGROUND

MeSH Terms

Conditions

Heart ArrestDeath, Sudden, CardiacShock

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsSorption Detoxification

Study Officials

  • Alain Cariou, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2008

First Posted

October 27, 2008

Study Start

November 2, 2008

Primary Completion

January 2, 2016

Study Completion

January 2, 2016

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations

FR(1)