Clinical trial NCT05122884: Milrinone Versus Placebo in Patients With Septic Shock
Official title: Effect of Milrinone Versus Placebo on Hemodynamics in Patients With Septic Shock; Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Septic Shock
Cardiac Output
Keywords: Milrinone
Septic shock
Cardiac output
Poor tissue perfusion
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change of cardiac output from baseline (before study drug administration) to 6 hours (during study administration)
timeFrame: upto 24 hours
Secondary outcomes:
measure: Intensive care unit (ICU) mortality
timeFrame: upto 120 days
measure: Hospital mortality
timeFrame: upto 120 days
measure: 28-day mortality
timeFrame: upto 28 days
measure: Dose of vasopressor after intervention
timeFrame: upto 7 days
measure: Lactate clearance
timeFrame: upto 7 days
measure: Mechanical ventilator free day
timeFrame: upto 28 days
measure: Extracorporeal membrane oxygenation (ECMO) or Renal replacement therapy (RRT)
timeFrame: upto 28 days
measure: Incident of tachyarrhythmia
timeFrame: upto 28 days
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Hat Yai Hospital
state: Songkhla
city: Bangkok
country: Thailand
facility: Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Surat Tongyoo
role: PRINCIPAL_INVESTIGATOR
References: