The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000, China
NCT Number: NCT06462313
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.
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All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more in both groups.
Time frame: within 1 week after surgery
Incidence of acute kidney injury after surgery
Time frame: 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
Time frame: in hospital and Day 28 and Day 90 after the surgery
Mortality
Time frame: before surgery (0 hour), 1hour after begining of surgery and at the end of surgey
Lactate level measurement
Time frame: before surgery (0 hour), 1hour after begining of surgery and at the end of surgey
capillary filling time
Time frame: before surgery (0 hour), 1hour after begining of surgery and at the end of surgey
Central venous oxygen saturation (ScvO2)
Time frame: 1hour after begining of surgery and at the end of surgey
Urine volume
Time frame: intraoperatively
Duration of norepinephrine intraoperatively
Time frame: intraoperatively
Cumulative dose of norepinephrine intraoperatively
Time frame: intraoperatively
Incidence of intraoperative arrythmia
Time frame: through study completion, an average of 1 year
Postoperative complication
Time frame: through study completion, an average of 1 year
Length of hospital stay after sugery
Time frame: 28 days postoperatively
ICU-free days with 28 days postoperatively
Time frame: through study completion, an average of 1 year
Duration of mechanical ventilation in ICU
Time frame: through study completion, an average of 1 year
Renal replacement therapy within the first 7 days after the surgery
Time frame: through study completion, an average of 1 year
Duration of renal replacement therapy
Time frame: through study completion, an average of 1 year
ICU-Mortality
Time frame: through study completion, an average of 1 year
In-hosipital Mortality
Time frame: through study completion, an average of 1 year
Hospitalization costs
First Affiliated Hospital of Zhejiang University
Other
Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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