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Extracorporeal Life SupportRetroECMO-VPNCT03968926

Hypotension During Extracorporeal Circulatory Support Indicated for Cardiogenic Shock

An observational study of Extracorporeal Life Support and Hypotension, run by University Hospital, Montpellier at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The cardiogenic shock is characterized by an alteration of organs function following a decrease in cardiac output linked to an impairment of cardiac performance. The prognosis remains poor with mortality between 40 and 50%. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Arterial pressure management during circulatory support by VA-ECMO
Type of treatment
Injection or infusion
How many people
150 participants
Where
1 siteFrance
Study dates
30 Jun 2019to 30 Dec 2020
Phase
Observational
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted in intensive care unit for cardiogenic shock at the Montpellier University Hospital and who required a VA-ECMO implantation

Who may be able to join

  • Refractory cardiogenic shock due to an acute coronary syndrome, a decompensation of chronic heart failure, a infectious or adrenergic myocarditis, or in a post-cardiotomy setting
  • Admitted in our intensive care unit between January 2015 and December 2018
  • Vasoplegia during the first 48 hours of VA-ECMO requiring more than 0.1µg/kg/min of Norepinephrine continuous infusion

Who cannot join

  • Others etiologies of cardiogenic shock : heart transplant dysfunction, right ventricular failure after left ventricular assist device implantation, drug intoxication, hypothermia, pulmonary embolism
  • Primary septic shock
  • Cardiac arrest with a no-flow time greater than 5 min or a low-flow time greater than 45 min
  • Opposition to participate after reception of the information letter

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Uh Montpellier

    Montpellier, 34295

    Philippe Gaudard, MD, +33665849543, p-gaudard@chu-montpellier.fr

    Recruiting

Other trials in France

About this study

Official title: Vasoplegia During VA-ECMO for Refractory Cardiogenic Shock : Descriptive Analysis of a Retrospective Cohort

The cardiogenic shock is characterized by an alteration of organs function following a decrease in cardiac output linked to an impairment of cardiac performance. The prognosis remains poor with mortality between 40 and 50%. Nowadays, Extracorporeal Life Support (ECLS or VA-ECMO) is the referent therapy to restore blood flow in the body when medical treatment is not sufficient. Despite a good blood flow provided by the ECLS, many patients develop a severe hypotension (so called vasoplegia) due to a loss of vascular resistance mainly explained by the inflammatory response to shock and extracorporeal circulation. The treatment of this reaction includes vasopressors (Norepinephrine in usual care) and serum surrogate perfusion to achieve a mean arterial pressure (MAP) above 65 mmHg.

The purpose of this study is to describe the patients with vasoplegia among a retrospective cohort of patients treated with an ECLS in our university center, over the 4 last years, to determine major complication rate (including death, kidney failure and arrythmias) and their outcome. This study will provide consistent data useful for further trials about targets of pressure and treatments to increase blood pressure during ECLS.

Read the detailed description

Cardiogenic shock is characterized by global tissue hypoperfusion following a decrease in cardiac output by impairing myocardial performance in the absence of hypovolemia. This life-threatening hypoperfusion quickly leads to multiple organs dysfunction with a high risk of cardiac arrest. The main cause is ischemic. The prognosis remains poor with mortality between 40 and 50% and depends on the speed of care by a specialized team. Early etiologic treatment is essential, but initial symptomatic management is based on catecholamines, mainly norepinephrine and dobutamine. The intra-aortic balloon pump showed no improvement in survival in large randomized studies. Refractory cardiogenic shock is defined by the inefficiency or intolerance of catecholamines and the indication of temporary circulatory support should be considered as soon as possible in the absence of contraindications (comorbidities, advanced age, therapeutic limitation). The veno-arterial extracorporeal membrane oxygenation (VA-ECMO or ECLS) is the preferred circulatory assistance in this indication because it provides an overall circulatory support up to 100% of the theoretical cardiac output, with oxygenation, and is quickly implanted peripherally (surgical or percutaneous cannulation of the femoral vein and the femoral artery). However, this extracorporeal circulation also has disadvantages by opposing a major afterload to the failing left ventricle and reducing or even abolishing the pulmonary circulation and blood flow in the heart chambers. In addition, the interaction with the artificial surfaces and the oxygenation membrane of the extracorporeal circuit contributes to the inflammatory response already initiated as a result of low cardiac output, tissue hypoperfusion, mesenteric ischemia and possibly myocardial infarction in case of acute coronary syndrome. This systemic inflammatory response syndrome (SIRS) is similar to sepsis and its main clinical presentation is a vascular dysfunction resulting in vasoplegia and capillary leak syndrome responsible for relative hypovolemia and interstitial inflation.

Since the flow provided by the centrifugal pump is continuous, the blood pressure under VA-ECMO presents low or no pulsatile waves and is better represented by the mean arterial pressure (MAP). The ideal targets of MAP under VA-ECMO are controversial but it is widely accepted that the MAP should not be less than 65mmHg as recommended in septic shock to maintain an acceptable perfusion pressure and should not exceed 95mmHg to limit afterload. Between these limits, the MAP must be individualized according to each situation (hypertensive patient for example). In France, Norepinephrine is the first-line drug to achieve this goal of MAP after correction of volemia, without dose limitation in the absence of currently validated alternative, while resistance mechanisms can be activated, and its efficiency may be limited in case of acidosis. Potential side effects are the occurrence of atrial or ventricular arrhythmias, tachycardia, pro-inflammatory cytokine release, immunosuppression, renal dysfunction.

Management of MAP and vasopressors under VA-ECMO is poorly described in the literature (5), although Norepinephrine is widely used in routine practice. In particular, the investigators do not know the frequency of use and Norepinephrine doses during ECMO-VA, as well as their prognostic involvement. Vasoplegia during VA-ECMO is defined by a Norepinephrine dose greater than 0.1µg/kg/min after a 500ml fluid challenge despite overall blood flow (ECMO + native heart) greater than 2l/min/m2 or allowing to achieve 65% of ScvO2.

This cohort study aims to describe the vasoplegia observed during VA-ECMO, the Norepinephrine treatment characteristics, complications and outcome. The primary end-point is the incidence of a composite criteria of major complications including death, acute kidney injury and arrythmias.

Being tested
Arterial pressure management during circulatory support by VA-ECMO
Keywords
Cardiogenic shock, Temporary circulatory support, Vasoplegia, Inflammatory response
Medical subject headings
Hypotension, Vasoplegia, Shock, Cardiogenic

What participants receive

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

  • Arterial pressure management during circulatory support by VA-ECMOOther

    Norepinephrine continuous infusion to maintain mean arterial pressure above 65 mmHg or at a higher level depending of the perfusion pressure targeted for the patient (mean arterial pressure between 65 and 85 mmHg)

Study groups in NCT03968926
Study groupRoleWhat they receive
Vasoplegic ECMOAll patients during VA-ECMO support for cardiogenic shock who presented, within 48 hours after implantation, a vasoplegia defined by a norepinephrine dose greater than 0.1µg/kg/min after a 500ml fluid challenge despite overall blood flow (ECMO + native heart) greater than 2l/min/m2 or allowing to achieve 65% of ScvO2
Receives: Other: Arterial pressure management during circulatory support by VA-ECMO

What is being measured

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

  1. Major complication composite criteria

    Observation of acute kidney injury defined by KDIGO classification 2 or 3, or severe arrythmia (i.e. atrial fibrillation with heart rate above 150bpm or a mean arterial pressure decrease of at least 20%, sustained ventricular tachycardia, ventricular fibrillation), or death

    Measured: Up to 7 days for acute kidney injury and arrythmia, and 30 days for death

Secondary outcomes (17)
  1. Initial refractory hypotension

    Norepinephrine dose maintained always above 1µg/kg/min during the first 2 hours after VA-ECMO implantation for a minimal mean arterial pressure target at 65mmHg

    Measured: Up to 2 hours

  2. Refractory vasoplegia

    Norepinephrine dose above 1µg/kg/min required to maintain mean arterial pressure above 65mmHg or at the personalized mean arterial pressure target

    Measured: Up to 7 days

  3. Mortality rate

    Overall mortality rate

    Measured: Through ICU discharge, an average of 1 month, up to 7, 30 and 90 days

  4. VA-ECMO free days

    Number of days alive free of VA-ECMO at 30 days after VA-ECMO implantation

    Measured: At 30 days from the VA-ECMO implantation

  5. Mean arterial pressure

    lowest and highest mean arterial pressure (mmHg)

    Measured: Up to 7 days

  6. Pulse pressure

    lowest and highest pulse pressure (mmHg) defined by the difference between systolic and diastolic pressure

    Measured: Up to 7 days

  7. Native cardiac output

    lowest and highest cardiac output (L/min) measured by echocardiography (Doppler aortic Velocity Time Integration) or by a pulmonary artery catheter

    Measured: Up to 7 days

  8. ECMO flow

    lowest and highest flow of VA-ECMO (L/min)

    Measured: Up to 7 days

  9. Lactate

    Highest lactate level of the day (mmol/l)

    Measured: Up to 7 days

  10. ScvO2

    Highest and lowest central venous oxygen saturation (%)

    Measured: Up to 7 days

  11. Urine output

    Total urine output of the day (ml/24H)

    Measured: Up to 7 days

  12. Hydric balance

    Total hydric balance calculated from day 0 to day 7 (ml)

    Measured: Up to 7 days

  13. Hospital stay

    Length (days) of hospital stay from the VA-ECMO implantation before current care ward discharge (excluding rehabilitation time)

    Measured: through study completion, an average of 3 month

  14. Intensive care unit stay

    Length (days) of intensive care unit stay from the VA-ECMO implantation

    Measured: through study completion, an average of 3 month

  15. Issue of VA-ECMO

    Status after VA-ECMO including death, heart transplant, ventricular assist device, recovery, shock recurrence, therapy limitation

    Measured: 7 days after VA-ECMO withdrawal

  16. Serious adverse events

    Stroke, bleeding requiring blood transfusion or surgical revision, limb ischemia, mesenteric ischemia, documented infection

    Measured: Trough VA-ECMO time completion, an average of 2 weeks

  17. Organ failure assessment

    Sequential Organ Failure Assessment score (0 to 24), higher values represent a worse outcome

    Measured: At day 0, 5 and 10 after VA-ECMO implantation

Timeline

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

  1. First posted30 May 2019
  2. Study start30 Jun 2019
  3. Primary completion1 Dec 2020 (estimated)
  4. Study completion30 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03968926
Sponsor's protocol ID
RECHMPL19_0049
Acronym
RetroECMO-VP
Status last verified
Mar 2020
First submitted
23 May 2019
Last updated
10 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van Diepen S, Katz JN, Albert NM, Henry TD, Jacobs AK, Kapur NK, Kilic A, Menon V, Ohman EM, Sweitzer NK, Thiele H, Washam JB, Cohen MG; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Mission: Lifeline. Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2017 Oct 17;136(16):e232-e268. doi: 10.1161/CIR.0000000000000525. Epub 2017 Sep 18.

    PubMed 28923988
  • Tanaka D, Shimada S, Mullin M, Kreitler K, Cavarocchi N, Hirose H. What Is the Optimal Blood Pressure on Veno-Arterial Extracorporeal Membrane Oxygenation? Impact of Mean Arterial Pressure on Survival. ASAIO J. 2019 May/Jun;65(4):336-341. doi: 10.1097/MAT.0000000000000824.

    PubMed 29762229

Questions about this trial

What is this clinical trial studying?

An observational study of Extracorporeal Life Support and Hypotension, run by University Hospital, Montpellier 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 4 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: status not confirmed, as of the sponsor's last update on 10 Mar 2020. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Philippe Gaudard, MD (+33665849543, p-gaudard@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major complication composite criteria (time frame: Up to 7 days for acute kidney injury and arrythmia, and 30 days for death). 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 NCT03968926, 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 10 Mar 2020.

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