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Shock, SepticPhase 3BétaSepNCT02609152

Effect of a Continuous Infusion of Esmolol on Stroke Volume in Patients With Hyperdynamic Vasoplegic Septic Shock

A Phase 3 study testing Continuous perfusion of esmolol and Continuous perfusion of saline in people with Shock, Septic, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main objective of this study is to evaluate the effectiveness of the administration of a short acting beta-blocker in terms of effective increase in stroke volume (at least 15%) after 4 hours initiation of therapy in septic shock in patients with a hyperkinetic profile after 12-24 hours of care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shock, Septic
What is being tested?
Continuous perfusion of esmolol and Continuous perfusion of saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesFrance
Study dates
Jul 2016to Aug 2017
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

  • The patient or his/her representative was informed about the implementation of the study, its objectives, constraints and patient rights or emergency consent
  • The patient or his/her representative must haven given free and informed consent and signed the consent or emergency consent
  • The patient must be affiliated with or the recipient of a health insurance plan
  • Septic shock criteria: shock for which the suspected or proven starting point is an infection requiring vasopressors after adequate fluid resuscitation that started within the past 24 to 72 hours
  • Precharge independence criteria obtained: i.e. pulsed pressure variation <13% or variation in ejection volume <10% or variation in the cardiac index after passive lift leg <10% or central venous pressure between 8 and 12 mmHg.
  • Antibiotic treatment in progress
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  • Prescription ongoing vasopressor for 24 to 72 hours.
  • Sinus rhythm
  • Heart rate > 100 beats per minute
  • Cardiac Index measured by thermodilution greater than 4.0 l / min / m^2
  • Central venous oxygen saturation > 80% without positive inotropics such as dobutamine or isoproterenol (continuously taken or measured via central venous line in superior vena cava territory) on two successive samples in 12 hours
  • Monitoring of stroke volume (invasive, semi-invasive or ultrasound)

Who cannot join

  • The patient is participating in another study
  • The patient has participated in another study in the last 3 months
  • The patient is in an exclusion period determined by a previous study
  • The patient is under any kind of guardianship
  • The patient is under judicial protection
  • The patient or his/her representative refuses to sign the consent
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  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • The patient has a contraindication for a treatment used in this study
  • Cardiac index < 4.0 l / min / m^2
  • Need to introduce a positive inotropic agent (as determined by the physician in charge of the patient)
  • Contraindications to the use of esmolol: Severe sinus bradycardia (less than 50 beats per minute); Sinus pathologies, severe disorders of atrioventricular conduction (without pacemaker), atrioventricular blocks of second and third degree; Cardiogenic shock; Severe hypotension; Decompensated heart failure; Untreated pheochromocytoma; Pulmonary hypertension; Acute asthma attack; chronic obstructive pulmonary disease; peripheral arterial disease; Metabolic acidosis; Known hypersensitivity to esmolol.
  • Patient with kidney failure (RIFLE Stage L)
  • Chronic treatment with beta blocker
  • Patient with ultrasound assessment of left ventricular ejection fraction < 40%

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • APHM - Hôpital Nord

    Marseille, 13915

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

Official title: Effect of a Continuous Infusion of Esmolol on Stroke Volume in Patients With Hyperdynamic Vasoplegic Septic Shock: a Multicentre, Randomized, Double-blind Trial

The main objective of this study is to evaluate the effectiveness of the administration of a short acting beta-blocker in terms of effective increase in stroke volume (at least 15%) after 4 hours initiation of therapy in septic shock in patients with a hyperkinetic profile after 12-24 hours of care.

This research seeks to demonstrate that the proportion of patients with an increase in the systolic ejection superior or equal to 15% (relative to baseline) at four hours is different between the two arms of the study: (1) an experimental arm where patients receive an esmolol infusion according to a predetermined procedure and (2) a control arm where patients receive a saline infusion according to a predetermined procedure.

Read the detailed description

The secondary objectives are to compare the following items between the two arms of the study:

  1. Central venous oxygen saturation at 4 hours (H4)
  2. Changes in plasma concentration of lactates between H0 and H4
  3. Changes in the tissue oxygen saturation between H0 and H4
  4. Changes in echocardiographic parameters of systolic function of the left ventricle (LV) and right ventricle (RV), as well as diastolic LV function between H0 and H4
  5. Vascular Filling volume during the study period
  6. Kidney function: urine output and creatinine changes between H0 and H4
  7. The required vasopressor time between H0 and H4
  8. Use of positive inotropic agents
  9. The inflammatory response via the analysis of HLA-DR between H0 and H4 and M1 / M2 responses at H4
  10. The duration of ICU stay, mortality, morbidity in terms of organ failures
Conditions
Shock, Septic
Being tested
Continuous perfusion of esmolol, Continuous perfusion of saline
Medical subject headings
Shock, Septic

What participants receive

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

  • Continuous perfusion of esmololDrug

    In the experimental arm of the study, a continuous perfusion of esmolol will be performed. This infusion starts at 5 ml / h with an increase of 5 ml / hr every 10 minutes to obtain a 15% decrease in heart rate. The infusion will be reduced by 5 ml / h every 5 minutes if the cardiac rate is less than 90 beats per minute and stopped if it is less than 70 beats per minute. At H4, the doctor in charge is free to gradually continue or stop the infusion.

  • Continuous perfusion of salineDrug

    In the control arm of the study, a continuous infusion of normal saline will be performed. This infusion starts at 5 ml / h with an increase of 5 ml / hr every 10 minutes to obtain a 15% decrease in heart rate. The infusion will be reduced by 5 ml / h every 5 minutes if the cardiac rate is less than 90 beats per minute and stopped if it is less than 70 beats per minute. A H4, the doctor in charge is free to gradually continue or stop the infusion.

Study groups in NCT02609152
Study groupRoleWhat they receive
Continuous perfusion of esmololExperimentalIntervention: Drug: Continuous perfusion of esmolol
Receives: Drug: Continuous perfusion of esmolol
Continuous perfusion of salinePlacebo comparatorIntervention: Continuous perfusion of saline
Receives: Drug: Continuous perfusion of saline

What is being measured

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

  1. Is stroke volume increased ≥ 15% as compared to baseline?

    Measured: 4 hours

Secondary outcomes (30)

  1. The time spent with a central venous oxygen saturation between 70% and 80% (minutes)

    Measured: 4 hours

  2. Evolution of blood lactate between H0 and H4

    Measured: 4 hours

  3. Changes in tissue oxygen saturation compared to baseline

    Measured: 4 hours

  4. Ejection fraction of the left ventricle drops below 40% between H0 and H4? yes/no

    Measured: 4 hours

  5. the change (in %) of the systolic S wave on the tissue doppler at the mitral annulus relative to baseline

    Measured: 4 hours

  6. Change (%) in the sub aortic time-speed integral relative to baseline

    Measured: 4 hours

  7. Absolute values of the E wave

    Measured: baseline (hour 0)

  8. Absolute values of the E wave

    Measured: 4 hours

  9. Absolute values of the E' wave

    Measured: baseline (hour 0)

  10. Absolute values of the E' wave

    Measured: 4 hours

  11. Absolute value of the ratio E/A on pulsed Doppler at the mitral annulus

    Measured: baseline (hour 0)

  12. Absolute value of the ratio E/A on pulsed Doppler at the mitral annulus

    Measured: 4 hours

  13. Absolute Value of the ratio E/E ' one tissue Doppler at the mitral annulus

    Measured: baseline (hour 0)

  14. Absolute Value of the ratio E/E ' one tissue Doppler at the mitral annulus

    Measured: 4 hours

  15. Right ventricular systolic function

    Measured: baseline (hour 0)

  16. Right ventricular systolic function

    Measured: 4 hours

  17. right ventricle / left ventricle diameter ratio

    Measured: baseline (hour 0)

  18. right ventricle / left ventricle diameter ratio

    Measured: 4 hours

  19. Vascular filling volume (ml)

    Measured: 4 hours

  20. Diuresis (ml/kg/h)

    Measured: collected between hours 0 and 4

  21. Change in creatinine relative to baseline (µmol/L)

    Measured: 4 hours

  22. Required duration of vasopressors (min)

    Measured: 4 hours

  23. Use of positive ionotropic agents? yes/no

    Measured: 4 hours

  24. Percentage variation o, inflammatory cytokines (tissue necrosis factor) with respect to baseline values

    Measured: 4 hours

  25. Percentage variation o, inflammatory cytokines (interleukin 1) with respect to baseline values

    Measured: 4 hours

  26. Percentage variation o, inflammatory cytokines (interleukin 10) with respect to baseline values

    Measured: 4 hours

  27. Percentage change in the expression of the human leukocyte antigen-DR gene with respect to baseline

    Measured: 4 hours

  28. Length of stay in the intensive care unit (days)

    The maximum observed length of stay in the intensive care unit (days) = Dmax

    Measured: Expected maximum of 28 days

  29. Number of days free of organ failure

    Measured: Dmax +1 (Dmax has an expected maximum of 28 days)

  30. Mortality

    Measured: Dmax +1 (Dmax has an expected maximum of 28 days)

Timeline

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

  1. First posted20 Nov 2015 (estimated)
  2. Study startJul 2016 (estimated)
  3. Primary completionJul 2017 (estimated)
  4. Study completionAug 2017 (estimated)

Why it stopped: logistical difficulties

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02609152
Sponsor's protocol ID
LOCAL/2014/ML-01
Other IDs
2015-000895-90, 2015
Acronym
BétaSep
Status last verified
May 2018
First submitted
17 Nov 2015
Last updated
17 May 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Continuous perfusion of esmolol and Continuous perfusion of saline in people with Shock, Septic, run by Centre Hospitalier Universitaire de Nīmes at 2 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 12 inclusion and 15 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: withdrawn, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.

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?

Is stroke volume increased ≥ 15% as compared to baseline? (time frame: 4 hours). 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 NCT02609152.

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 17 May 2018.

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