Clinical trial

Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor

Name
Dobutamine
Description
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.
Trial arms
Trial start
2024-06-20
Estimated PCD
2027-04-30
Trial end
2027-04-30
Status
Not yet recruiting
Treatment
Dobutamine
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.
Arms:
Dobutamine, norepinephrine
Norepinephrine
Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more in both groups.
Arms:
Dobutamine, norepinephrine, Norepinephrine
Size
584
Primary endpoint
Incidence of acute kidney injury after surgery
1 week after surgery
Sequential Organ Failure Assessment (SOFA) score
Day 1 Day 3 and Day 7 in ICU after surgery
Mortality
Day 28 and Day 90 after the surgery
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. Patients with a history of Cardiac insufficiency; 3. Patients with acute coronary syndrome within the last 3 months; 4. Patients with severe valvular heart disease; 5. Patients with chronic renal insufficiency; 6. Long-term intakeβ-receptor blocker; 7. Patients use Recombinant Human Brain Natriuretic Peptide(rhBNP), Levosimendan and Epinephrine within 24 hour before the sugery; 8. Patients with hyperthyroidism; 9. Allergy or known sensitivity to catecholamines(norepinephrine, dobutamine etc.)and genera anesthetics. 10. Patients and guardians refused to participate in this intervention clinical trial.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 584, 'type': 'ESTIMATED'}}
Updated at
2024-06-17

1 organization

2 products

3 indications

Product
Dobutamine
Indication
Septic Shock