Milrinone Versus Placebo in Patients With Septic Shock

Mahidol University

Status and phase: Enrolling; Phase 2

Conditions: Cardiac Output; Septic Shock

Treatments: Drug: Milrinone

Study type: Interventional

Funder types: Other

Identifiers

NCT05122884

SI 111/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Milrinone group

Experimental group

Description:

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.

Treatment:

Drug: Milrinone

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Milrinone