Sepsis
Conditions
Interventions
Ivabradine group:Standard treatment for sepsis plus enteral ivabradine.
Standard treatment group:Standard treatment for sepsis
Sponsors
The Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who meet the following criteria are eligible to be included in the trial: (1) Adult patients aged 18 years or above. (2) Being treated in an intensive care unit. (3) Sepsis is diagnosed according to Sepsis-3.0 criteria, which is defined as patients requiring antimicrobial agents due to confirmed or suspected infection, acute increase in the SOFA score at least 2 points. (4) Mean arterial pressure (MAP) is maintained >=65 mmHg with adequate volume resuscitation and vasopressor therapy. Volume resuscitation is considered adequate when Central Venous Pressure (CVP) > 8mmHg, global end-diastolic volume index (GEDI) > 680ml/m2 and resting inferior vena cava (IVC) diameter > 1.5cm. (5) Sinus rhythm with heart rate >= 95bpm maintain for at least 2 hours but less than 72 hours.
Exclusion criteria
Exclusion criteria: The participant shall not enroll the trial if any of the following applies: (1) Patients who had received ivabradine therapy or known sensitivity to it prior to randomization. (2) Patients with severe liver dysfunction (Child-C grade). (3) Patients with known seizure disorder. (4) Patients with any contraindication to gastrointestinal drug administration. (5) Pregnant or lactating patients. (6) patients requiring the use of potent cytochrome CYP3A4 inhibitors such as antifungals of the azole-type (specifically ketoconazole and itraconazole), macrolide antibiotics (specifically clarithromycin and erythromycin) and HIV protease inhibitors (specifically nelfinavir and ritonavir). (7) Patients with active bleeding; (8) Patients with cardiac dysfunction caused by non-septic causes such as acute myocardial infarction, chronic cardiac dysfunction, congenital heart disease, pericardial tamponade, severe aortic regurgitation and aortic coarctation before enrollment. (9) Patients with refractory shock, which may be considered if one of the following conditions still exists in spite of active volume resuscitation, high doses of vasoactive drugs (VIS score >120), and other conventional therapy: 1) Worsening hypotension (MAP5mmol/L (two times in a row with an interval of more than 30min), and a progressive upward trend; 3) Mixed venous blood oxygen saturation (SvO2) sustained <55% (more than two consecutive times, more than 30min apart), and progressive deterioration. The above conditions lasted for more than 5 hours. (10) After cardiopulmonary resuscitation. (11) Patients who have been enrolled in another interventional clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart rate;Blood pressure;Stroke index;Cardiac Index;Dynamic and venous blood gas analysis;Myocardial enzymology ;Lactate;Procalcitonin;C-reactive protein;interleukin-6;Tumor necrosis factor-a; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood routine examination;Serological test of liver and kidney function;Brain natriuretic peptide; | — |
Countries
China
Contacts
Public ContactZhenhui Zhang
The Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed