Cardiac Output, Septic Shock
Conditions
Keywords
Milrinone, Septic shock, Cardiac output, Poor tissue perfusion
Brief summary
Sepsis is one of the most serious healthcare problems, worldwide, and financial burdens. The overall mortality of severe sepsis/septic shock was 44.5-52.6%. A common cause of death is refractory shock and multi-organ failure. Myocardial dysfunction is a relatively common complication of septic shock. This causes a decrease in the amount of cardiac output, resulting in insufficient blood supply to the organ and multi-organ failure and lead to death Early goal-directed therapy began to use dobutamine in patients with septic shock Sepsis Survival Campaign Guideline 2016 recommended drug is dobutamine and an alternative drug is milrinone in septic shock patients with clinical signs of poor tissue perfusion.
Detailed description
According to several studies, the use of dobutamine increases the amount of cardiac output but it has also been reported to increase mortality rates too. There are few studies of milrinone in patients with septic shock.
Interventions
DRUGMilrinone
Prepare milrinone 20 mg with NSS 100 ml then starts dose 0.5 mg/kg/min for up to 12 hours.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Pharmacist who does not involve in patient enrollment nor treatment will prepared milrinone or placebo in the identical container, before the study drug will be given to patients, according to their treatment arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years old * Diagnosis Septic Shock from the definition of SEPSIS III in intensive care unit at Siriraj hospital and Hat-Yai hospital * Receive fluid resuscitation at least 30 ml/kg and/or Vasopressor until mean arterial pressure ≥ 65 mmHg * Persistence lactate \>2mmol/L at 6th hour after resuscitation * Urine output \< 0.5 ml/kg at 6th hour after resuscitation * Left ventricular ejection fraction (LVEF) \< 40 %
Exclusion criteria
* Chronic kidney disease stage 5 and denied renal replacement therapy * Life-threatening tachyarrhythmia before enrolled e.g. Ventricular tachycardia, Ventricular fibrillation * Patient sign do-not-resuscitation and terminally ill
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of cardiac output from baseline (before study drug administration) to 6 hours (during study administration) | upto 24 hours | by echocardiogram or Pulse contour analysis or Thermodilution technique from pulmonary artery catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital mortality | upto 120 days | Proportion of participant who die during hospital admission |
| 28-day mortality | upto 28 days | Proportion of participant who die during 28 days after enrollment |
| Dose of vasopressor after intervention | upto 7 days | present as vasopressor equivalent dose compare before and after intervention, and percent of decrease |
| Intensive care unit (ICU) mortality | upto 120 days | Proportion of participant who die during ICU admission |
| Mechanical ventilator free day | upto 28 days | day of the patient does not use mechanical ventilator during admission |
| Extracorporeal membrane oxygenation (ECMO) or Renal replacement therapy (RRT) | upto 28 days | incident of initial ECMO or RRT |
| Incident of tachyarrhythmia | upto 28 days | Incident of ventricular tachycardia, ventricular fibrillation, Atrial fibrillation |
| Lactate clearance | upto 7 days | lactate level after and before intervention and percent clearance |
Countries
Thailand
Contacts
Primary ContactSurat Tongyoo, Doctor
Backup ContactSuratee Chobngam, Doctor
Outcome results
None listed