Trial · NCT02369900
Esmolol to Treat the Hemodynamic Effects of Septic Shock
NCT02369900, Phase 2, Terminated, Beth Israel Deaconess Medical Center; results first posted 2021-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Esmolol to Treat the Hemodynamic Effects of Septic Shock. Trials, record NCT02369900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02369900
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Esmolol to Treat the Hemodynamic Effects of Septic Shock
- NCT number
- NCT02369900
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Septic Shock, Hypotension, Tachycardia
- Interventions
- Esmolol, Saline
- First posted
- 2015-02-24
- Last updated
- 2021-06-28
- Results first posted
- 2021-06-28
- Limitations and caveats
The trial ended early due to slow enrollments and ending of funding before the target enrollment was reached. Many patients with septic shock were excluded because of the absence of tachycardia, or due to the presence of myocardial dysfunction. We did not collect echocardiographic data. Patients in the esmolol arm had differing exposures to esmolol, based on variable dosing and duration due to individual patient characteristics.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Need for Vasopressor Support, Measured as Mean Norepinephrine Equivalent Dose (mcg/kg/Min), at 6hr Time Point | 6 hours | The primary endpoint will be mean norepinephrine equivalent dose (mcg/kg/min) at 6 hours after onset of study drug. For the vasopressor vasopressin, the dose of vasopressin was multiplied by 2.5 in order to create a norepinephrine equivalent dose. For the vasopressor phenylephrine, the dose of phenylephrine was divided by 10 in order to create a norepinephrine equivalent dose. |
| Secondary | Overall Need for Vasopressor Support | 12 and 24 hours | While the primary endpoint will be mean norepinephrine dose at 6h, we will also measure mean vasopressor dose in groups at 12h and 24h. |
| Secondary | Heart Rates Between Groups | 6 and 12 hours | We will measure median heart rate at the 6 and 12h time points. |
| Secondary | Time to Shock Reversal | Duration of hospitalization, limit 180 days | Time to shock reversal (cessation of all vasopressors for at least 12h). |
| Secondary | Lactate | 6, 12, and 24 hours | Median percent change from baseline lactate measured at the 6, 12, and 24 hour time points after study initiation between groups. Percent change was calculated by subtracting the later lactate from the baseline lactate and dividing the difference by the baseline lactate (i.e. (baseline lactate - 6h lactate)/baseline lactate). |
| Secondary | Oxygen Consumption (VO2) | 12 and 24 hours | To analyze the difference in oxygen consumption between groups at 12 hours, 24 hours and over time for patients who were on mechanical ventilation at enrollment, VO2 measurements were compared (standardized by bodyweight in kilograms) over time (recorded every minute from the time of study drug administration over a period of at least 24 hours) between groups using mixed linear model accounting for repeated measures. Using an unadjusted model, mean differences at 12 hours, 24 hours and for differences in the overall trend over time were tested. |
| Secondary | Interleukin-4 | 12 and 24 hours | To characterize effects of esmolol on inflammatory markers in patients with vasopressor-dependent septic shock, we compared log-transformed values of interleukin-4 at 12 and 24 hours and over time between groups using mixed linear model accounting for repeated measures and adjusting for pre-intervention levels. |
| Secondary | Interleukin-6 | 12 and 24 hours | To characterize effects of esmolol on inflammatory markers in patients with vasopressor-dependent septic shock, we compared log-transformed values of interleukin-6 at 12 and 24 hours and over time between groups using mixed linear model accounting for repeated measures and adjusting for pre-intervention levels. |
| Secondary | Interleukin-10 | 12 and 24 hours | To characterize effects of esmolol on inflammatory markers in patients with vasopressor-dependent septic shock, we compared log-transformed values of interleukin-10 at 12 and 24 hours and over time between groups using mixed linear model accounting for repeated measures and adjusting for pre-intervention levels. |
| Secondary | TNF-alpha | 12 and 24 hours | To characterize effects of esmolol on inflammatory markers in patients with vasopressor-dependent septic shock, we compared log-transformed values of TNF-alpha at 12 and 24 hours and over time between groups using mixed linear model accounting for repeated measures and adjusting for pre-intervention levels. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Need for Vasopressor Support, Measured as Mean Norepinephrine Equivalent Dose (mcg/kg/Min), at 6hr Time Point | 6 hours | mcg/kg/min | MEAN | |
| SECONDARY | Overall Need for Vasopressor Support | 12 and 24 hours | mcg/kg/min | MEAN | |
| SECONDARY | Heart Rates Between Groups | 6 and 12 hours | beats per minutes | MEDIAN | |
| SECONDARY | Time to Shock Reversal | Duration of hospitalization, limit 180 days | days | MEDIAN | |
| SECONDARY | Lactate | 6, 12, and 24 hours | One patient in the standard care group was missing lactate levels at 6, 12, and 24 hours and one patient in the standard care group was missing a lactate level at 24 hours. | percent change from baseline | MEDIAN |
| SECONDARY | Oxygen Consumption (VO2) | 12 and 24 hours | Only patients on mechanical ventilation who were able to be attached to the VO2 machine and had data within the first 24 hours were included. | mL/kg/min | MEDIAN |
| SECONDARY | Interleukin-4 | 12 and 24 hours | Blood was not able to be drawn from all patients at all time points. | pg/mL | MEDIAN |
| SECONDARY | Interleukin-6 | 12 and 24 hours | Blood was not able to be drawn from all patients at all time points. | pg/mL | MEDIAN |
| SECONDARY | Interleukin-10 | 12 and 24 hours | Blood was not able to be drawn from all patients at all time points. | pg/mL | MEDIAN |
| SECONDARY | TNF-alpha | 12 and 24 hours | Blood was not able to be drawn from all patients at all time points. | pg/mL | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Need for Vasopressor Support, Measured as Mean Norepinephrine Equivalent Dose (mcg/kg/Min), at 6hr Time Point | Esmolol Infusion | 0.30 | Standard Deviation 0.17 | mcg/kg/min | |
| Need for Vasopressor Support, Measured as Mean Norepinephrine Equivalent Dose (mcg/kg/Min), at 6hr Time Point | Standard Care, Saline | 0.21 | Standard Deviation 0.19 | mcg/kg/min | |
| Overall Need for Vasopressor Support | Esmolol Infusion | 12 hours | 0.31 | Standard Deviation 0.19 | mcg/kg/min |
| Overall Need for Vasopressor Support | Standard Care, Saline | 12 hours | 0.17 | Standard Deviation 0.17 | mcg/kg/min |
| Overall Need for Vasopressor Support | Esmolol Infusion | 24 hours | 0.24 | Standard Deviation 0.19 | mcg/kg/min |
| Overall Need for Vasopressor Support | Standard Care, Saline | 24 hours | 0.16 | Standard Deviation 0.17 | mcg/kg/min |
| Heart Rates Between Groups | Esmolol Infusion | 6 hours | 92 | Inter-Quartile Range 89 to 104 | beats per minutes |
| Heart Rates Between Groups | Standard Care, Saline | 6 hours | 98 | Inter-Quartile Range 89 to 110 | beats per minutes |
| Heart Rates Between Groups | Esmolol Infusion | 12 hours | 89 | Inter-Quartile Range 79 to 105 | beats per minutes |
| Heart Rates Between Groups | Standard Care, Saline | 12 hours | 96 | Inter-Quartile Range 85 to 105 | beats per minutes |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Esmolol Infusion | 18 | |
| Overall Study | STARTED | Standard Care, Saline | 22 | |
| Overall Study | COMPLETED | Esmolol Infusion | 18 | |
| Overall Study | COMPLETED | Standard Care, Saline | 22 | |
| Overall Study | NOT COMPLETED | Esmolol Infusion | 0 | |
| Overall Study | NOT COMPLETED | Standard Care, Saline | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Decrease in Cardiac Index | Cardiac disorders | Esmolol Infusion | 4 | 18 | 4 |
| serious | Decrease in Cardiac Index | Cardiac disorders | Standard Care, Saline | 0 | 22 | 0 |
| serious | Abnormal Heart Rhythym | Cardiac disorders | Esmolol Infusion | 1 | 18 | 1 |
| serious | Abnormal Heart Rhythym | Cardiac disorders | Standard Care, Saline | 0 | 22 | 0 |
| serious | PEA arrest | General disorders | Esmolol Infusion | 1 | 18 | 1 |
| serious | PEA arrest | General disorders | Standard Care, Saline | 0 | 22 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Esmolol Infusion | 6 | 18 |
| Total, all-cause mortality | Standard Care, Saline | 8 | 22 |
| Total, other adverse events | Esmolol Infusion | 0 | 18 |
| Total, other adverse events | Standard Care, Saline | 0 | 22 |
| Total, serious adverse events | Esmolol Infusion | 4 | 18 |
| Total, serious adverse events | Standard Care, Saline | 0 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35066509 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Esmolol Infusion vs Standard Care, Saline: deaths from any cause | Trial comparisons |
| Esmolol Infusion vs Standard Care, Saline: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02369900
GET https://conductscience.org/api/trials/v1/NCT02369900/results?page=2