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

NCT ID: NCT02794025

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-01-31

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

Detailed Description

enrollment:151 patients

Inclusion criteria: (1) age > 18 years; (2) 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, who (3) mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg; and (4) satisfactory sedation and analgesic treatment, with HR > 100 bpm.

Conditions

Severe Sepsis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

esmolol group

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

Group Type: EXPERIMENTAL

Esmolol

Intervention Type: 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.

control group

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

Group Type: SHAM_COMPARATOR

natural saline

Intervention Type: DRUG

Control group also received natural saline via a micro pump,

Interventions

Esmolol

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.

Intervention Type: DRUG

natural saline

Control group also received natural saline via a micro pump,

Intervention Type: DRUG

Other Intervention Names

β-blockers

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Provincial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiuling Shang

the ethic committee of Fujian Provincial Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rongguo Yu, MD

Role: STUDY_DIRECTOR

Fujian Provincial Hospital

Other Identifiers

K2010-001-01

Identifier Type: -

Identifier Source: org_study_id