Milrinone Versus Placebo in Patients With Septic Shock

  • STATUS
    Recruiting
  • End date
    Jun 27, 2025
  • participants needed
    64
  • sponsor
    Mahidol University
Updated on 27 November 2021

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.

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.

Details
Condition septic shock, Cardiac Output, Toxic Shock Syndrome
Treatment Milrinone
Clinical Study IdentifierNCT05122884
SponsorMahidol University
Last Modified on27 November 2021

Eligibility

Yes No Not Sure

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
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