The Effect of Esmolol on Patients With Sepsis

• Sponsor: Shanghai Zhongshan Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04537767
• Collaborator: (none)
• Enrollment: 120
• Arms: 2
• Anticipated Duration (Months): 35.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Drug: Esmolol; Drug: Placebo	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Effect of Esmolol on Patients With Sepsis
• Anticipated Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. REE [Day 7 after enrollment]

   Resting energy expenditure

Secondary Outcome Measures

1. 28-day mortality rate [Day 28 after enrollment]

   28-day mortality rate

2. HR control rate [24 hours after enrollment]

   target heart rate control rate

3. Vasoactive drug administration dose [Day 1/3/7 after enrollment]

   Vasoactive drug administration dose

4. Concentration of Lac [Day 1/3/7 after enrollment]

   Concentration of lactic acid

5. O2ER [Day 1/3/7 after enrollment]

   oxygen extraction rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT04537767
• Other Study ID Numbers: ES-01
• First Posted: Sep 3, 2020
• Last Update Posted: Sep 3, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanghai Zhongshan Hospital: sepsis; septic shock; esmolol
• Additional relevant MeSH terms: Sepsis; Toxemia; Esmolol

Study Results

No Results Posted as of Sep 3, 2020