Clinical trial NCT06462313: Dobutamine for Management of Surgical Patients with Septic Shock
Official title: Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patients with Septic Shock
Surgical Patients
General Anesthesia
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Ningbo No. 1 Hospital
name: Lishui Country People's Hospital
name: The Central Hospital of Lishui City
name: Zhejiang Provincial Tongde Hospital
name: Ningbo No.2 Hospital
name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: The First Affiliated Hospital of Zhengzhou University
name: Zunyi Medical College
name: The Second Hospital of Hebei Medical University
name: Affiliated Hospital of Jiaxing University
name: First Affiliated Hospital of Xinjiang Medical University
name: The First Affiliated Hospital of Anhui Medical University
name: Huaibei Peolple's Hospital
name: Anqing People's Hospital of Anhui Medical University
name: The Second Hospital University of South China
name: The First Affiliated Hospital of University of South China
name: Wenzhou people's hospitalï¼Œzhejiang province,China
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: The First Clinical College of Harbin University
name: The First Affiliated Hospital of Shihezi University Medical College
name: Weifang People's Hospital
name: Tianjin Medical University General Hospital
name: Central Hospital of Heng Yang
name: First Affiliated Hospital of Shenzhen University
name: Henan Provincial People's Hospital
name: Southwest Hospital, China
name: The First People's Hospital of Zunyi
name: Affiliated Hospital of Guangdong Medical University
name: Union hospital of Fujian Medical University
name: Bijie Hospital of Zhejiang Provincial People's Hospital
name: Red Cross Hospital, Hangzhou, China
name: Weihai Municipal Hospital
name: The First Affiliated Hospital of Soochow University
name: Zhejiang Cancer Hospital
name: Renmin Hospital of Wuhan University
name: Wuhan Third Hospital
name: Tongji Hospital
name: Zhujiang Hospital
name: Fuyang Hospital of Anhui Medical University
name: The Hospital of Suixi County
name: Fujian Provincial Hospital
name: Guizhou Provincial People's Hospital
name: Zhejiang Provincial Peopleâ€™s Hospital
First posted: 2024-06-17
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of acute kidney injury after surgery
timeFrame: within 1 week after surgery
measure: Sequential Organ Failure Assessment (SOFA) score
timeFrame: Day 1 Day 3 and Day 7 in ICU after surgery
measure: Mortality
timeFrame: in hospital and Day 28 and Day 90 after the surgery
Secondary outcomes:
measure: Lactate level measurement
timeFrame: before surgery (0 hour), 1hour after begining of surgery and at the end of surgey
measure: capillary filling time
timeFrame: before surgery (0 hour), 1hour after begining of surgery and at the end of surgey
measure: Central venous oxygen saturation (ScvO2)
timeFrame: before surgery (0 hour), 1hour after begining of surgery and at the end of surgey
measure: Urine volume
timeFrame: 1hour after begining of surgery and at the end of surgey
measure: Duration of norepinephrine intraoperatively
timeFrame: intraoperatively
measure: Cumulative dose of norepinephrine intraoperatively
timeFrame: intraoperatively
measure: Incidence of intraoperative arrythmia Incidence of intraoperative arrythmia
timeFrame: intraoperatively
measure: Postoperative complication
timeFrame: through study completion, an average of 1 year
measure: Length of hospital stay after sugery
timeFrame: through study completion, an average of 1 year
measure: ICU-free days with 28 days postoperatively
timeFrame: 28 days postoperatively
measure: Duration of mechanical ventilation in ICU
timeFrame: through study completion, an average of 1 year
measure: Renal replacement therapy
timeFrame: through study completion, an average of 1 year
measure: Duration of renal replacement therapy
timeFrame: through study completion, an average of 1 year
measure: ICU-Mortality
timeFrame: through study completion, an average of 1 year
measure: In-hosipital Mortality
timeFrame: through study completion, an average of 1 year
measure: Hospitalization costs
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
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