Cardiac ArrestPhase 3HyperdiaNCT00780299
Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability in Post-resuscitation Shock
A Phase 3 study testing hemodialysis with high permeability (HDHP) and CVVH in people with Cardiac Arrest and Sudden Cardiac Death, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Sudden Cardiac Death, Shock
- What is being tested?
- hemodialysis with high permeability (HDHP) and CVVH
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2008to 2 Jan 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- weight > 100 kg
- without social security
- another clinical trial ongoing
- cardiac arrest from non cardiac etiology
Trial locations and contacts
1 site in 1 country.
France1 site
Medical intensive care unit of Cochin-St Vincent de Paul university Hospital
Paris, 75679
About this study
Official title: Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability (HDHP) During the Early Period of Post-resuscitation Shock
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.
Read the detailed 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).
- Conditions
- Cardiac Arrest, Sudden Cardiac Death, Shock
- Being tested
- hemodialysis with high permeability (HDHP), CVVH
- Keywords
- Plasma epuration, Hemofiltration, Cardiac arrest, Shock, Inflammatory mediators
- Medical subject headings
- Heart Arrest, Death, Sudden, Cardiac, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodialysis with high permeability (HDHP)Device
HDHP (hemodialysis with high permeability) is a specific plasma epuration of inflammatory mediators
CVVHProcedure or surgery
hemofiltration intermittent dialysis
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | control Receives: Procedure: CVVH |
| 1 | Experimental | HDHP Receives: Device: hemodialysis with high permeability (HDHP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main endpoint will be the duration of the shock expressed by the length of catecholamine infusion
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study start2 Nov 2008
- Primary completion2 Jan 2016
- Study completion2 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Gambro Industries, MEYZIEU, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Alain Cariou, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780299
- Sponsor's protocol ID
- P071005
- Acronym
- Hyperdia
- Status last verified
- Sep 2025
- First submitted
- 24 Oct 2008
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30974188
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability (HDHP) During the Early Period of Post-resuscitation Shock
- ClinicalTrials.gov ID
- NCT00780299
- Acronym / sponsor ID
- Hyperdia / P071005
- Conditions
- Cardiac Arrest, Sudden Cardiac Death, Shock
- Keywords
- Plasma epuration, Hemofiltration, Cardiac arrest, Shock, Inflammatory mediators
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Gambro Industries, MEYZIEU, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 2 Nov 2008 (actual)
- Primary completion
- 2 Jan 2016 (actual)
- Study completion
- 2 Jan 2016 (actual)
- First posted
- 27 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Procedure: CVVHcontrol |
| 1 | Experimental | Device: hemodialysis with high permeability (HDHP)HDHP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemodialysis with high permeability (HDHP)HDHP (hemodialysis with high permeability) is a specific plasma epuration of inflammatory mediators | Device | 1 |
| CVVHhemofiltration intermittent dialysis | Procedure or surgery | 2 |
Primary outcome
The main endpoint will be the duration of the shock expressed by the length of catecholamine infusion
Time frame: 28 days
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 30974188Geri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Cariou, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hemodialysis with high permeability (HDHP) and CVVH in people with Cardiac Arrest and Sudden Cardiac Death, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main endpoint will be the duration of the shock expressed by the length of catecholamine infusion (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00780299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.