Dobutamine for Management of Surgical Patients With Septic Shock
NCT Number: NCT06462313
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patients With Septic Shock|Surgical Patients|General Anesthesia
Interventions: DRUG: Dobutamine|DRUG: Norepinephrine
Sponsor: First Affiliated Hospital of Zhejiang University
Collaborators: 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
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 584
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2027-04-30
Locations: The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310000, China

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.

Primary Outcome Measures: Incidence of acute kidney injury after surgery, Incidence of acute kidney injury after surgery, 1 week after surgery|Sequential Organ Failure Assessment (SOFA) score, Sequential Organ Failure Assessment (SOFA) score, ranges from 0 to 24, with 24 being the worst, Day 1 Day 3 and Day 7 in ICU after surgery|Mortality, Mortality, Day 28 and Day 90 after the surgery
Secondary Outcome Measures: Lactate level measurement, Lactate level measurement, before surgery (0 hour), 1hour after begining of surgery and at the end of surgey|capillary filling time, capillary filling time, before surgery (0 hour), 1hour after begining of surgery and at the end of surgey|Central venous oxygen saturation (ScvO2), Central venous oxygen saturation (ScvO2), before surgery (0 hour), 1hour after begining of surgery and at the end of surgey|Urine volume, Urine volume, 1hour after begining of surgery and at the end of surgey|Duration of norepinephrine intraoperatively, Duration of norepinephrine intraoperatively, intraoperatively|Cumulative dose of norepinephrine intraoperatively, Cumulative dose of norepinephrine intraoperatively, intraoperatively|Incidence of intraoperative arrythmia Incidence of intraoperative arrythmia, Incidence of intraoperative arrythmia, intraoperatively|Postoperative complication, Postoperative complication, through study completion, an average of 1 year|Length of hospital stay after sugery, Length of hospital stay after sugery, through study completion, an average of 1 year|ICU-free days with 28 days postoperatively, ICU-free days with 28 days postoperatively, 28 days postoperatively|Duration of mechanical ventilation in ICU, Duration of mechanical ventilation in ICU, through study completion, an average of 1 year|Renal replacement therapy, Renal replacement therapy within the first 7 days after the surgery, through study completion, an average of 1 year|Duration of renal replacement therapy, Duration of renal replacement therapy, through study completion, an average of 1 year|ICU-Mortality, ICU-Mortality, through study completion, an average of 1 year|In-hosipital Mortality, In-hosipital Mortality, through study completion, an average of 1 year|Hospitalization costs, Hospitalization costs, through study completion, an average of 1 year