The Effect of Esmolol on Clinical Prognosis of Patients With Severe Sepsis

NCT02794025 | Completed DMC

• 1 other identifier: K2010-001-01
• Study Type: interventional
• Target: 151
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to investigate the effect of esmolol on hemodynamic parameters,tissue perfusion and the clinical prognosis of patients with severe sepsis

Conditions

Severe Sepsis

Outcome Measures

Primary Outcomes (1)

• The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death.

  28 days

Study Arms (2)

esmolol group

EXPERIMENTAL

patients in the esmolol group received continuous infusion of esmolol via a micro-pump through a catheter placed in the superior vena cava.

Drug: Esmolol

control group

SHAM COMPARATOR

Control group also received natural saline via a micro pump, in the same way the esmolol group received esmolol.

Drug: natural saline

Interventions

Esmolol DRUG

patients in the esmolol group received continuous infusion of esmolol via a micro-pump through a catheter placed in the superior vena cava. The initial dose was 0.05 mg/kg/min and was adjusted based on heart rate (HR) (target HR: 70 bpm \< HR \< 100 bpm within 72 hours). Control group also received natural saline via a micro pump, in the same way the esmolol group received esmolol.

Also known as: β-blockers

esmolol group

natural saline DRUG

Control group also received natural saline via a micro pump,

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years;
• severe sepsis (acute organ dysfunction secondary to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment Guidelines for Severe Sepsis and Septic Shock,
• mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg;
• satisfactory sedation and analgesic treatment, with HR \> 100 bpm.

You may not qualify if:

• pre-existing cardiac dysfunction, valvular heart disease, high-degree atrioventricular block;
• acute or chronic pulmonary heart disease;
• a history of serious asthma;
• chronic renal insufficiency;
• cancer, autoimmune diseases, or contraindications for placement of deep venous catheter;
• insulin-dependent diabetes.

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

MeSH Terms

Conditions

Sepsis

Interventions

esmolol

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rongguo Yu, MD

  Fujian Provincial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the ethic committee of Fujian Provincial Hospital

Study Record Dates

• First Submitted: June 4, 2016
• First Posted: June 8, 2016
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 8, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share