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Cardiogenic ShockPhase 4OptimaCCNCT01367743

Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock

A Phase 4 study testing epinephrine perfusion and norepinephrine perfusion in people with Cardiogenic Shock, run by Central Hospital, Nancy, France at 11 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The efficacy and tolerability of norepinephrine and epinephrine in cardiogenic shock after reperfused myocardial infarction will be compared, by following cardiac index evolution as main criteria. The study is a pilot pathophysiological study, randomized, double blind and multicenter. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiogenic Shock
What is being tested?
epinephrine perfusion and norepinephrine perfusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
11 sitesFrance
Study dates
Sep 2011to Aug 2016
Phase
Phase 4
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

  • man or woman older than 18 years
  • cardiogenic shock due to myocardial infarction treated by angioplasty
  • SAP < 90 MM Hg or MAP < 65 mm Hg without vasopressor or vasopressor necessity
  • sign of tissue hypoperfusion
  • cardiac index < 2.2 l/mn/m2 in the absence of vasopressive or inotropic therapy
  • pulmonary artery occlusion pressure > 15 mmHg or echocardiographic evidence of high pressure (mitral profile)
  • exclusion of covert hypovolemia : Delta PP if feasible should be > 13% (patient adapted to the ventilator and sinus rhythm) and /or no response to passive leg raising
  • ejection fraction < 40% in ultrasound without inotrope support. This criteria will not be taken into account in instances of treatment with dopamine, norepinephrine, epinephrine, dobutamine or milrinone.

Who cannot join

  • shock of other origin
  • immediate indications for mechanical assistance device
  • minor aged patients
  • patients for whom written consent - by patient or family - has not been obtained. Given the seriousness of the medical situation at the time of inclusion, patient consent will be difficult if not impossible to obtain. The inclusion will only be possible after information is provided and consent is obtained from a family member. As soon as possible, protocol information will be issued to the patient in order to obtain consent for continuance.
  • cardiac arrest with early signs of cerebral anoxia.
  • septic, toxic and obstructive cardiomyopathy
Show all 12Show fewer
  • arrhythmogenic cardiomyopathy
  • patient with coronary insufficiency
  • patient with ventricular rhythm disorders
  • patient treated with a medicine listed in contre indication
  • patient without social assurance
  • patient major under legal protection or safeguard justice

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • CHU de BESANCON / Hôpital Jean Minjoz

    Besançon, 25030

  • CHU de DIJON

    Dijon, 21079

  • CHU de LIMOGES Hôpital Dupuytren

    Limoges, 87042

  • APHM Hôpital NORD

    Marseille, 13015

  • Chr Metz Thionville

    Metz, 57000

  • CH de MULHOUSE

    Mulhouse, 68070

  • AP-HP-Hôpital Cochin

    Paris, 75014

  • CHU de STRASBOURG / NHC

    Strasbourg, 67091

  • CHU Toulouse

    Toulouse

  • Chru Tours

    Tours, 37044

  • Nancy Brabois university hospital

    Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54500

Other trials in France

About this study

Official title: Optimizing the Use of Vasopressor After Coronary Reperfusion in Cardiogenic Shock Secondary to Myocardial Infarction. Pathophysiological Study Comparing the Efficacy and Cardio-circulatory Tolerability of Epinephrine and Norepinephrine

The efficacy and tolerability of norepinephrine and epinephrine in cardiogenic shock after reperfused myocardial infarction will be compared, by following cardiac index evolution as main criteria. The study is a pilot pathophysiological study, randomized, double blind and multicenter.

Read the detailed description

Cardiogenic shock secondary to myocardial infarction is a frequent pathology in reanimation and is associated with high mortality (50%). Hemodynamic management and notably the choice of vasopressor in cardiogenic shock states secondary to myocardial infarction (cardiac index < 2.2 l/min/m-2) is not codified. There are two opposite views: a) the first is based on the fact that an hypotensive patient with low cardiac output is primarily in need of an inotropic agent and that, consequently, epinephrine is the molecule of choice (inotropic and vasoconstrictor); b) the second is based on the fact that hypotension also reflects a certain degree of vascular failure and vascular vasoplegia and therefore norepinephrine is the molecule of choice along with, if needed, the eventual addition of dobutamine in order to separately titrate vasoconstriction and inotropism.

Study hypotheses: epinephrine could facilitate myocardial function by providing the latter with its preferred substrate (lactate) and thus induce a higher cardiac index along with increased energy expenditure. Norepinephrine is the therapy of choice of hypotensive states; nevertheless its lack of inotropic effect could theoretically exacerbate myocardial failure. Thus, the aim of the study is to compared the efficiency and the tolerability of norepinephrine and epinephrine in cardiogenic shock after reperfused myocardial infarction.

Being tested
epinephrine perfusion, norepinephrine perfusion
Keywords
myocardial infarction, epinephrine, norepinephrine, cardiac output
Medical subject headings
Shock, Cardiogenic, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epinephrine perfusionDrug

    Also called vasopressor, catecholamine

    perfusion of commercial epinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg

  • norepinephrine perfusionDrug

    Also called vasopressor, catecholamine

    perfusion of commercial norepinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg

Study groups in NCT01367743
Study groupRoleWhat they receive
epinephrineActive comparatorNot described
Receives: Drug: epinephrine perfusion
norepinephrineActive comparatorNot described
Receives: Drug: norepinephrine perfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compared effects of investigated drugs on cardiac index

    effectiveness of the treatment assessed by the evolution of cardiac index

    Measured: H0; H2, H4, H6, H12, H24, H48 and H72

Secondary outcomes (11)

  1. pro/anti-inflammatory cytokines

    Compared effects of investigated drugs on pro/anti-inflammatory cytokines

    Measured: H0, H24, H48 and H72

  2. BNP

    Compared effects of investigated drugs on BNP

    Measured: H0, H24, H48 and H72

  3. Troponin

    Compared effects of investigated drugs on Troponin

    Measured: H0, H24, H48 and H72

  4. catecholamine doses

    Compared effects of investigated drugs on the catecholamine doses

    Measured: H0, H24, H48 and H72

  5. organ failure (SOFA Score)

    Compared effects of investigated drugs on the organ failure

    Measured: H0, H24, H48 and H72

  6. Lactate clearance

    Compared effects of investigated drugs on the Lactate clearance

    Measured: H0, H2, H6, H12, H24 and H48

  7. heart rate

    Compared effects of investigated drugs on heart rate and the incidence of arrhythmia

    Measured: H0, H2, H4, H6, H12, H24, H48 and H72

  8. cardiac power index

    Compared effects of investigated drugs on cardiac power

    Measured: H0, H2, H4, H6, H12, H24, H48 and H72.

  9. SVO2

    Compared effects of investigated drugs on the SVO2

    Measured: H0, H2, H4, H6, H12, H24, H48 and H72.

  10. cardiac double product

    Compared effects of investigated drugs on the cardiac double product

    Measured: H0, H2, H4, H6, H12, H24, H48 and H72.

  11. refractory cardiogenic shock

    compared effects of the investigated drugs on the occurrence of refractory cardiogenic shock

    Measured: H0, H2, H4, H6, H12, H24, H48 and H72.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionFeb 2016
  4. Study completionAug 2016

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01367743
Sponsor's protocol ID
2009-017081-23
Other IDs
2009
Acronym
OptimaCC
Status last verified
Jan 2019
First submitted
10 May 2011
Last updated
1 Feb 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Takagi K, Blet A, Levy B, Deniau B, Azibani F, Feliot E, Bergmann A, Santos K, Hartmann O, Gayat E, Mebazaa A, Kimmoun A. Circulating dipeptidyl peptidase 3 and alteration in haemodynamics in cardiogenic shock: results from the OptimaCC trial. Eur J Heart Fail. 2020 Feb;22(2):279-286. doi: 10.1002/ejhf.1600. Epub 2019 Aug 31.

    PubMed 31472039

  • Levy B, Clere-Jehl R, Legras A, Morichau-Beauchant T, Leone M, Frederique G, Quenot JP, Kimmoun A, Cariou A, Lassus J, Harjola VP, Meziani F, Louis G, Rossignol P, Duarte K, Girerd N, Mebazaa A, Vignon P; Collaborators. Epinephrine Versus Norepinephrine for Cardiogenic Shock After Acute Myocardial Infarction. J Am Coll Cardiol. 2018 Jul 10;72(2):173-182. doi: 10.1016/j.jacc.2018.04.051.

    PubMed 29976291

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing epinephrine perfusion and norepinephrine perfusion in people with Cardiogenic Shock, run by Central Hospital, Nancy, France at 11 sites 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 8 inclusion and 12 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 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Compared effects of investigated drugs on cardiac index (time frame: H0; H2, H4, H6, H12, H24, H48 and H72). 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 NCT01367743, which also lists 2 linked publications.

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 1 Feb 2019.

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