A Phase 2 interventional study of Milrinone in Septic Shock and Cardiac Output, sponsored by Mahidol University. Status unknown at 2 sites in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-15.
Sponsored by Mahidol University · Phase 2, Interventional, and Treatment
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.
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.
890 studies on the registry are indexed under Shock, Septic; 210 are open to participants now.
This study's planned enrollment of 64 is below the median of 78 across 547 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Mahidol University is the lead sponsor of 744 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: 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
Drug: Milrinone
Prepare milrinone 20 mg with NSS 100 ml then starts dose 0.5 mg/kg/min for up to 12 hours.
Also known as: Primacor
The change of cardiac output from baseline (before study drug administration) to 6 hours (during study administration)
by echocardiogram or Pulse contour analysis or Thermodilution technique from pulmonary artery catheter
Time frame: upto 24 hours
Intensive care unit (ICU) mortality
Proportion of participant who die during ICU admission
Time frame: upto 120 days
Hospital mortality
Proportion of participant who die during hospital admission
Time frame: upto 120 days
28-day mortality
Proportion of participant who die during 28 days after enrollment
Time frame: upto 28 days
Dose of vasopressor after intervention
present as vasopressor equivalent dose compare before and after intervention, and percent of decrease
Time frame: upto 7 days
Lactate clearance
lactate level after and before intervention and percent clearance
Time frame: upto 7 days
Mechanical ventilator free day
day of the patient does not use mechanical ventilator during admission
Time frame: upto 28 days
Extracorporeal membrane oxygenation (ECMO) or Renal replacement therapy (RRT)
incident of initial ECMO or RRT
Time frame: upto 28 days
Incident of tachyarrhythmia
Incident of ventricular tachycardia, ventricular fibrillation, Atrial fibrillation
Time frame: upto 28 days
Plan to share: Yes — Anonymous identification data will be prepared per request, after study publication 6 months.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: 6 months post study publication
Access criteria: Request to principal investigation, after protocal approval from ethical committee.
Started Dec 2021 (actual). Primary completion is estimated for Dec 2024, 36 months after the start.
Of 34 non-industry phase 2 interventional studies under Shock, Septic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 33. This study's planned 36 months is above that.
Counting every sponsor, half of 38 studies reached it within 29 months; a quarter within 15 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Milrinone