General Anesthesia, Patients With Septic Shock, Surgical Patients
Conditions
Brief summary
Septic shock is the last and most severe stage of sepsis and is defined by extremely low blood pressure, despite lots of intravenous fluids. The incidence of septic shock related cardiomyopathy was 10% to 70%. Besides, general anesthesia will inhibit the sympathetic nervous system, reduce myocardial contractility and aggravate cardiac dysfunction. No randomized controlled trials have yet explore the effects of dobutamine on clinical outcomes for patients with septic shock undergoing surgery under general anesthesia.
Detailed description
Sepsis, defined as life-threatening organ dysfunction, is caused by a dysregulated host response to infection, which 30-day mortality rate is about 24.4%. Septic shock is the last and most severe stage of sepsis and is defined by extremely low blood pressure, despite lots of intravenous fluids. Surgical patients with septic shock are not rare. The incidence of septic shock related cardiomyopathy was 10% to 70%. Besides, general anesthesia will inhibit the sympathetic nervous system, reduce myocardial contractility and aggravate cardiac dysfunction, furthermore exacerbate hemodynamic instability, and then increase the incidence of AKI and patient mortality. Therefore, to improve cardiac function in patients with septic shock who received general anesthesia is the key to save patients life and improve prognosis. The latest international guidelines for the treatment of septic shock recommend - in patients with septic shock combined with cardiac dysfunction, treatment with norepinephrine in combination with dobutamine is recommended if inadequate tissue perfusion persists after adequate fluid resuscitation and maintenance of blood pressure, but the level of evidence is weak. Dobutamine acts on β-adrenergic receptors, which can improve tissue perfusion, and small doses of 2.5-5ug/kg/min can increase myocardial contractility and improve cardiac function in patients without increasing heart rate. Previous study has demonstrated that the combined use of norepinephrine and dobutamine can elevate left ventricular ejection fraction, cardiac index, improve tissue perfusion, and reduce mortality in patients with septic shock. No randomized controlled trials have yet explore the effects of dobutamine on clinical outcomes for patients with septic shock undergoing surgery under general anesthesia.
Interventions
DRUGDobutamine
Patients with septic shock in Dobutamine group will be initiated on Dobutamine at 5 mcg/kg/min when electrocardiogram, invasive blood pressure, and oxygen saturation were monitored.
DRUGNorepinephrine
Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more in both groups.
Sponsors
Ningbo No. 1 Hospital
Lishui Country People's Hospital
The Central Hospital of Lishui City
Zhejiang Provincial Tongde Hospital
Ningbo No.2 Hospital
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
The First Affiliated Hospital of Zhengzhou University
Zunyi Medical College
The Second Hospital of Hebei Medical University
Affiliated Hospital of Jiaxing University
First Affiliated Hospital of Xinjiang Medical University
The First Affiliated Hospital of Anhui Medical University
Huaibei Peolple's Hospital
Anqing People's Hospital of Anhui Medical University
The Second Hospital University of South China
The First Affiliated Hospital of University of South China
Wenzhou people's hospital，zhejiang province,China
People's Hospital of Xinjiang Uygur Autonomous Region
The First Clinical College of Harbin University
The First Affiliated Hospital of Shihezi University Medical College
Weifang People's Hospital
Tianjin Medical University General Hospital
Central Hospital of Heng Yang
First Affiliated Hospital of Shenzhen University
Henan Provincial People's Hospital
Southwest Hospital, China
The First People's Hospital of Zunyi
Affiliated Hospital of Guangdong Medical University
Union hospital of Fujian Medical University
Bijie Hospital of Zhejiang Provincial People's Hospital
Red Cross Hospital, Hangzhou, China
Weihai Municipal Hospital
The First Affiliated Hospital of Soochow University
Zhejiang Cancer Hospital
Renmin Hospital of Wuhan University
Wuhan Third Hospital
Tongji Hospital
Zhujiang Hospital
Fuyang Hospital of Anhui Medical University
The Hospital of Suixi County
Fujian Provincial Hospital
Guizhou Provincial People's Hospital
Zhejiang Provincial People's Hospital
First Affiliated Hospital of Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with 18 years or older 2. Sugery patients with septic shock and the duration of opration is more than 1 hour
Exclusion criteria
1. Pregnancy; 2. Long-term intakeβ-receptor blocker; 3. patietns with dobutamine used within 72h before enrollment; 4. Patients use Recombinant Human Brain Natriuretic Peptide(rhBNP), Levosimendan and Epinephrine within 72h before enrollment; 5. Patients with hyperthyroidism; 6. Allergy or known sensitivity to catecholamines（norepinephrine, dobutamine etc.）and genera anesthetics. 7. Patients and guardians refused to participate in this intervention clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute kidney injury after surgery | within 1 week after surgery | Incidence of acute kidney injury after surgery |
| Sequential Organ Failure Assessment (SOFA) score | Day 1 Day 3 and Day 7 in ICU after surgery | Sequential Organ Failure Assessment (SOFA) score, ranges from 0 to 24, with 24 being the worst |
| Mortality | in hospital and Day 28 and Day 90 after the surgery | Mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central venous oxygen saturation (ScvO2) | before surgery (0 hour), 1hour after begining of surgery and at the end of surgey | Central venous oxygen saturation (ScvO2) |
| Urine volume | 1hour after begining of surgery and at the end of surgey | Urine volume |
| Duration of norepinephrine intraoperatively | intraoperatively | Duration of norepinephrine intraoperatively |
| Cumulative dose of norepinephrine intraoperatively | intraoperatively | Cumulative dose of norepinephrine intraoperatively |
| Incidence of intraoperative arrythmia Incidence of intraoperative arrythmia | intraoperatively | Incidence of intraoperative arrythmia |
| Postoperative complication | through study completion, an average of 1 year | Postoperative complication |
| Hospitalization costs | through study completion, an average of 1 year | Hospitalization costs |
| ICU-free days with 28 days postoperatively | 28 days postoperatively | ICU-free days with 28 days postoperatively |
| Duration of mechanical ventilation in ICU | through study completion, an average of 1 year | Duration of mechanical ventilation in ICU |
| Renal replacement therapy | through study completion, an average of 1 year | Renal replacement therapy within the first 7 days after the surgery |
| Duration of renal replacement therapy | through study completion, an average of 1 year | Duration of renal replacement therapy |
| ICU-Mortality | through study completion, an average of 1 year | ICU-Mortality |
| In-hosipital Mortality | through study completion, an average of 1 year | In-hosipital Mortality |
| Length of hospital stay after sugery | through study completion, an average of 1 year | Length of hospital stay after sugery |
| Lactate level measurement | before surgery (0 hour), 1hour after begining of surgery and at the end of surgey | Lactate level measurement |
| capillary filling time | before surgery (0 hour), 1hour after begining of surgery and at the end of surgey | capillary filling time |
Countries
China
Outcome results
None listed