This trial is active, not recruiting.

Conditions cardiac arrest, sudden cardiac death, shock
Treatments hemodialysis with high permeability (hdhp), cvvh
Phase phase 3
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator Gambro Industries, MEYZIEU, France
Start date October 2008
End date June 2016
Trial size 38 participants
Trial identifier NCT00780299, P071005


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
hemofiltration intermittent dialysis
hemodialysis with high permeability (hdhp)
HDHP (hemodialysis with high permeability) is a specific plasma epuration of inflammatory mediators

Primary Outcomes

The main endpoint will be the duration of the shock expressed by the length of catecholamine infusion
time frame: 28 days

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability (HDHP) During the Early Period of Post-resuscitation Shock
Principal investigator Alain Cariou, MD, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.