Milrinone Versus Placebo in Patients With Septic Shock
- Registration Number
- NCT05122884
- Lead Sponsor
- Mahidol University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- 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 %
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Milrinone group Milrinone The pharmacist prepares milrinone 20 mg with normal saline solution (NSS) 100 ml then starts dose 0.5 mg/kg/min for up to 12 hours. The doctor performs Echocardiogram before start Milrinone, during infusion, and after 12 hours from stop Milrinone. Other medications or interventions were used or not used depending on own doctor. Placebo group Milrinone The pharmacist uses 100 ml of NSS, packed out in the same format, dose, and administration of the drug were exactly the same as in the milrinone group. The doctor performs Echocardiogram same time as the milrinone group
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 28-day mortality upto 28 days Proportion of participant who die during 28 days after enrollment
Intensive care unit (ICU) mortality upto 120 days Proportion of participant who die during ICU admission
Hospital mortality upto 120 days Proportion of participant who die during hospital admission
Dose of vasopressor after intervention upto 7 days present as vasopressor equivalent dose compare before and after intervention, and percent of decrease
Lactate clearance upto 7 days lactate level after and before intervention and percent clearance
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
Trial Locations
- Locations (2)
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
🇹🇭Bangkok, Thailand
Hat Yai Hospital
🇹🇭Hat Yai, Songkhla, Thailand