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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Shock; Sudden Cardiac Death; Cardiac Arrest

Treatments: Device: hemodialysis with high permeability (HDHP); Procedure: CVVH

Study type: Interventional

Funder types: Other

Identifiers

NCT00780299

P071005

Details and patient eligibility

About

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.

Full 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).

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

38 participants in 2 patient groups

2

Active Comparator group

Description:

control

Treatment:

Procedure: CVVH

1

Experimental group

Description:

HDHP

Treatment:

Device: hemodialysis with high permeability (HDHP)