Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability in Post-resuscitation Shock (Hyperdia)
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|ClinicalTrials.gov Identifier: NCT00780299|
Recruitment Status : Active, not recruiting
First Posted : October 27, 2008
Last Update Posted : June 24, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest Sudden Cardiac Death Shock||Device: hemodialysis with high permeability (HDHP) Procedure: CVVH||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability (HDHP) During the Early Period of Post-resuscitation Shock|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||November 2016|
Active Comparator: 2
hemofiltration intermittent dialysis
Device: hemodialysis with high permeability (HDHP)
HDHP (hemodialysis with high permeability) is a specific plasma epuration of inflammatory mediators
- The main endpoint will be the duration of the shock expressed by the length of catecholamine infusion [ Time Frame: 28 days ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780299
|Medical intensive care unit of Cochin-St Vincent de Paul university Hospital|
|Paris, France, 75679|
|Principal Investigator:||Alain Cariou, MD, PhD||Assistance Publique - Hôpitaux de Paris|