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

Cardiac Arrest Clinical Trial

— Hyperdia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780299
• Other study ID #: P071005
• Status: Completed
• Phase: Phase 3
• Start date: November 2, 2008
• Est. completion date: January 2, 2016

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2, 2016
• Est. primary completion date: January 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Death
• Death, Sudden, Cardiac
• Heart Arrest
• Shock
• Sudden Cardiac Death

Intervention

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

Procedure:
• CVVH
hemofiltration intermittent dialysis

Locations

Country	Name	City	State
France	Medical intensive care unit of Cochin-St Vincent de Paul university Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Gambro Industries, MEYZIEU, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Geri G, Grimaldi D, Seguin T, Lamhaut L, Marin N, Chiche JD, Pène F, Bouglé 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 o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main endpoint will be the duration of the shock expressed by the length of catecholamine infusion		28 days
Secondary	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