TachycardiaNCT02188888
Echocardiographic and Arterial Pressure Waveform Changes After Reducing Heart Rate With Esmolol in Septic Shock Patients
An observational study of Tachycardia and Septic Shock, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Clinical study suggests that beta-blockers by decreasing heart rate together with an increase in stroke volume do not negatively affect cardiac output allowing an economization of cardiac work and oxygen consumption in patients with septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Septic Shock
- What is being tested?
- esmolol
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2013to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Septic shock patients with heart rate > of 95 bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) between 65 and 75 mmHg after at least 24 hours of hemodynamic optimization.
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, 00161
About this study
Official title: Heart Rate Reduction With Esmolol is Associated With Improved Arterial Elastance in Patients With Septic Shock. A Prospective Observational Study
Clinical study suggests that beta-blockers by decreasing heart rate together with an increase in stroke volume do not negatively affect cardiac output allowing an economization of cardiac work and oxygen consumption in patients with septic shock. Whether this hemodynamic profile leads to an amelioration of myocardial performance is still unclear. The objective of the present study is therefore to elucidate whether a reduction in heart rate with esmolol is associated to an improvement of cardiac efficiency in patients with septic shock who remained tachycardic after hemodynamic optimization.
Read the detailed description
After 24-36 hours of initial hemodynamic stabilization, 44 septic shock patients with heart rate > of 95 bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation,will receive a continuous esmolol infusion to maintain heart rate between 94 and 80 bpm. Norepinephrine will be titrated to achieve a MAP between 65 and 75 mmHg. To investigate myocardial performance, we will simultaneously assess LV ejection fraction (LVEF), tricuspidal annular plane solid excursion (TAPSE) by echocardiography, the dP/dt MAX and the cardiac cycle efficiency (CCE) both estimated from the arterial pressure waveform. Finally we will analyze changes in static arterial elastance. Data will be obtained at baseline and after four hours once achieved the predefined heart rate threshold.
- Conditions
- Tachycardia, Septic Shock
- Being tested
- esmolol
- Keywords
- septic shock, esmolol, tachycardia, betablockers
- Medical subject headings
- Tachycardia, Shock, Septic
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
| Study group | Role | What they receive |
|---|---|---|
| Tachycardic patients | Patients will receive a continuous esmolol infusion to maintain heart rate between 94 and 80 bpm. Norepinephrine will be titrated to achieve a MAP between 65 and 75 mmHg. Receives: Drug: esmolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
Measured: over a period of four hours
Secondary outcomes (2)
echocardiography
LV ejection fraction (LVEF) and tricuspidal annular plane solid excursion (TAPSE)
Measured: over a period of four hours
static arterial elastance
Measured: over a period of four hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJun 2014
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 TachycardiaStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Morelli, University of Roma La Sapienza
- Investigators
- Andrea Morelli, MD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188888
- Sponsor's protocol ID
- 2309
- Status last verified
- Aug 2015
- First submitted
- 10 Jul 2014
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Morelli A, Romano SM, Sanfilippo F, Santonocito C, Frati G, Chiostri M, Agro FE, Ertmer C, Rehberg SW, Vieillard-Baron A. Systolic-dicrotic notch pressure difference can identify tachycardic patients with septic shock at risk of cardiovascular decompensation following pharmacological heart rate reduction. Br J Anaesth. 2020 Dec;125(6):1018-1024. doi: 10.1016/j.bja.2020.05.058. Epub 2020 Jul 18.
PubMed 32690246
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Reduction With Esmolol is Associated With Improved Arterial Elastance in Patients With Septic Shock. A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02188888
- Acronym / sponsor ID
- 2309
- Conditions
- Tachycardia, Septic Shock
- Keywords
- septic shock, esmolol, tachycardia, betablockers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Jul 2014 (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.
Clinical study suggests that beta-blockers by decreasing heart rate together with an increase in stroke volume do not negatively affect cardiac output allowing an economization of cardiac work and oxygen consumption in patients with septic shock. Whether this hemodynamic profile leads to an amelioration of myocardial performance is still unclear. The objective of the present study is therefore to elucidate whether a reduction in heart rate with esmolol is associated to an improvement of cardiac efficiency in patients with septic shock who remained tachycardic after hemodynamic optimization.
Detailed description
After 24-36 hours of initial hemodynamic stabilization, 44 septic shock patients with heart rate > of 95 bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation,will receive a continuous esmolol infusion to maintain heart rate between 94 and 80 bpm. Norepinephrine will be titrated to achieve a MAP between 65 and 75 mmHg. To investigate myocardial performance, we will simultaneously assess LV ejection fraction (LVEF), tricuspidal annular plane solid excursion (TAPSE) by echocardiography, the dP/dt MAX and the cardiac cycle efficiency (CCE) both estimated from the arterial pressure waveform. Finally we will analyze changes in static arterial elastance. Data will be obtained at baseline and after four hours once achieved the predefined heart rate threshold.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tachycardic patients | – | Drug: esmololPatients will receive a continuous esmolol infusion to maintain heart rate between 94 and 80 bpm. Norepinephrine will be titrated to achieve a MAP between 65 and 75 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Septic shock patients with heart rate > of 95 bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) between 65 and 75 mmHg after at least 24 hours of hemodynamic optimization.
Key inclusion criteria (2 listed)
- septic shock criteria
- presence of heart rate > 95 bpm.
Key exclusion criteria (2 listed)
- Pregnancy
- age < 18
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 |
|---|---|---|
| esmololStrict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm | Drug | Tachycardic patients |
Primary outcome
heart rate
Time frame: over a period of four hours
2 secondary outcomes
echocardiography
Time frame: over a period of four hours
static arterial elastance
Time frame: over a period of four hours
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 7 Aug 2015.
- Derived from this study: PubMed 32690246Morelli A, Romano SM, Sanfilippo F, Santonocito C, Frati G, Chiostri M, Agro FE, Ertmer C, Rehberg SW, Vieillard-Baron A. Systolic-dicrotic notch pressure difference can identify tachycardic patients with septic shock at risk of cardiovascular decompensation following pharmacological heart rate reduction. Br J Anaesth. 2020 Dec;125(6):1018-1024. doi: 10.1016/j.bja.2020.05.058. Epub 2020 Jul 18.
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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.
Andrea Morelli, MD principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachycardia and Septic Shock, run by University of Roma La Sapienza 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 7 Aug 2015. 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.
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 four 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 NCT02188888, 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 7 Aug 2015.