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Septic ShockPhase 2NCT01231698

Heart Rate Control With Esmolol in Septic Shock

A Phase 2 study testing esmolol in people with Septic Shock, run by Andrea Morelli at 1 site in Italy.

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 purpose of this study is investigate the effects on systemic hemodynamics and organ function of esmolol when used to maintain heart rate below a predefined threshold in patients with septic shock. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock
What is being tested?
esmolol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteItaly
Study dates
Dec 2010to Jul 2012
Phase
Phase 2
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

  • septic shock criteria
  • presence of heart rate > 95 bpm.

Who cannot join

  • Pregnancy
  • age < 18

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Department of Anesthesiology and Intensive care of the University of Rome La Sapienza

    Rome

Other trials in Italy

About this study

Official title: Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study

The purpose of this study is investigate the effects on systemic hemodynamics and organ function of esmolol when used to maintain heart rate below a predefined threshold in patients with septic shock.

Read the detailed description

154 septic shock patients with heart rate > of 95 bpm and requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation, will be enrolled in the study. Patients will be randomly allocated to be treated with either a) a continuous esmolol infusion at any doses to maintain heart rate between 95 and 80 bpm b)to a standard treatment without heart rate control(control; each n = 77). In both groups, norepinephrine will be titrated to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg. Data from right heart catheterization,data from organ function as well as norepinephrine requirements will be obtained at baseline and after 24, 48, 72, and 96 hours. The protocol will require that esmolol be infused continuously at any doses to maintain the predefined heart rate threshold until one the following events occur: the patient die, a serious adverse effect attributed to the study drug infusion, or the patient has been discharged from ICU.

Conditions
Septic Shock
Being tested
esmolol, control
Keywords
septic shock, esmolol, tachycardia, betablockers
Medical subject headings
Shock, Septic, Tachycardia

What participants receive

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

  • esmololDrug

    Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm.

  • controlOther

    standard treatment without strict heart rate control

Study groups in NCT01231698
Study groupRoleWhat they receive
esmololExperimentalNot described
Receives: Drug: esmolol
controlOtherNot described
Receives: Other: control

What is being measured

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

  1. heart rate

    Measured: over a period of 96 hrs

Secondary outcomes (1)

  1. systemic hemodynamics

    systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.

    Measured: over a period of 96 hours

Timeline

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

  1. First posted1 Nov 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionJul 2012
  4. Study completionJul 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01231698
Sponsor's protocol ID
2048
Status last verified
Nov 2011
First submitted
29 Oct 2010
Last updated
24 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • Huang X, Zheng M, Zhu Z, Zhang Y, Chen KY. Association of anti-catecholaminergic antiarrhythmic drugs with survival in sepsis-associated new-onset atrial fibrillation. Sci Rep. 2026 Jul 6;16(1):20588. doi: 10.1038/s41598-026-51249-9.

    PubMed 42402640

  • Morelli A, Ertmer C, Westphal M, Rehberg S, Kampmeier T, Ligges S, Orecchioni A, D'Egidio A, D'Ippoliti F, Raffone C, Venditti M, Guarracino F, Girardis M, Tritapepe L, Pietropaoli P, Mebazaa A, Singer M. Effect of heart rate control with esmolol on hemodynamic and clinical outcomes in patients with septic shock: a randomized clinical trial. JAMA. 2013 Oct 23;310(16):1683-91. doi: 10.1001/jama.2013.278477.

    PubMed 24108526

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing esmolol in people with Septic Shock, run by Andrea Morelli at 1 site in Italy.

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 2 inclusion and 2 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 24 Jan 2013. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

heart rate (time frame: over a period of 96 hrs). 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 NCT01231698, 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 24 Jan 2013.

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