Dobutamine for Management of Surgical Patients with Septic Shock
- Conditions
- Patients with Septic ShockSurgical PatientsGeneral Anesthesia
- Interventions
- Registration Number
- NCT06462313
- Lead Sponsor
- First Affiliated Hospital of Zhejiang University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 584
- Patients with 18 years or older
- Sugery patients with septic shock and the duration of opration is more than 1 hour
- Pregnancy;
- Long-term intakeβ-receptor blocker;
- patietns with dobutamine used within 72h before enrollment;
- Patients use Recombinant Human Brain Natriuretic Peptide(rhBNP), Levosimendan and Epinephrine within 72h before enrollment;
- Patients with hyperthyroidism;
- Allergy or known sensitivity to catecholamines（norepinephrine, dobutamine etc.）and genera anesthetics.
- Patients and guardians refused to participate in this intervention clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Norepinephrine Norepinephrine Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more Dobutamine, norepinephrine Dobutamine Patients will be initiated on Dobutamine at 5 mcg/kg/min while continuous infusion of norepinephrine titrated to maintain a mean arterial pressure at 65mmHg or more Dobutamine, norepinephrine Norepinephrine Patients will be initiated on Dobutamine at 5 mcg/kg/min while continuous infusion of norepinephrine titrated to maintain a mean arterial pressure at 65mmHg or more
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Length of hospital stay after sugery through study completion, an average of 1 year Length of hospital stay after sugery
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
Hospitalization costs through study completion, an average of 1 year Hospitalization costs
Trial Locations
- Locations (1)
The First Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China