The Effect of Esmolol on Patients With Sepsis

The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis
• Intervention / Treatment: Drug: Placebo; Drug: Esmolol

Detailed Description

Severe sepsis, septic shock, and their complications have become the major healthcare problem that affects millions of people each year, resulting in high mortality rates. Septic responses have an extremely complex chain of events including inflammatory and anti-inflammatory processes, humoral and cellular reactions, and cardiocirculatory abnormalities. Esmolol may have some potential in treating septic shock and sepsis. The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• sepsis patients
• HR>100bpm 6h after admission
• with CVC and ScvO2>65%

Exclusion Criteria:

• age <18 years,
• used β-blocker before,
• cardiac dysrhythmias,
• need for an inotropic agent,
• valvular heart disease,
• hemoglobin>6g/L
• pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ES group; Patients randomly assigned to the ES group were treated with esmolol to control the heart rate to the target range.	Drug: Esmolol; The protocol required a titrated esmolol infusion commenced at 25 mg/ h, with an upper dose limit of 2000 mg/h, to maintain the HR between 75 and 90 bpm in ES group. The control group were treated with placebo.
Placebo Comparator: control group; Patients randomly assigned to the control group were treated with placebo.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
REE	Resting energy expenditure	Day 7 after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality rate	28-day mortality rate	Day 28 after enrollment
HR control rate	target heart rate control rate	24 hours after enrollment
Vasoactive drug administration dose	Vasoactive drug administration dose	Day 1/3/7 after enrollment
Concentration of Lac	Concentration of lactic acid	Day 1/3/7 after enrollment
O2ER	oxygen extraction rate	Day 1/3/7 after enrollment

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: June 14, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: septic shock; sepsis; esmolol
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-1 Receptor Antagonists; Esmolol
• Other Study ID Numbers: ES-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No