Milrinone Versus Placebo in Patients With Septic Shock

Septic Shock Clinical Trial

Official title:

Effect of Milrinone Versus Placebo on Hemodynamics in Patients With Septic Shock; Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05122884
• Other study ID #: SI 111/2021
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2021
• Est. completion date: June 2025

Study information

• Verified date: September 2022
• Source: Mahidol University
• Contact: Surat Tongyoo, Doctor
• Phone: +6624198534
• Email: surat_Ty[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Milrinone
Prepare milrinone 20 mg with NSS 100 ml then starts dose 0.5 mg/kg/min for up to 12 hours.

Locations

Country	Name	City	State
Thailand	Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok
Thailand	Hat Yai Hospital	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	upto 24 hours
Secondary	Intensive care unit (ICU) mortality	Proportion of participant who die during ICU admission	upto 120 days
Secondary	Hospital mortality	Proportion of participant who die during hospital admission	upto 120 days
Secondary	28-day mortality	Proportion of participant who die during 28 days after enrollment	upto 28 days
Secondary	Dose of vasopressor after intervention	present as vasopressor equivalent dose compare before and after intervention, and percent of decrease	upto 7 days
Secondary	Lactate clearance	lactate level after and before intervention and percent clearance	upto 7 days
Secondary	Mechanical ventilator free day	day of the patient does not use mechanical ventilator during admission	upto 28 days
Secondary	Extracorporeal membrane oxygenation (ECMO) or Renal replacement therapy (RRT)	incident of initial ECMO or RRT	upto 28 days
Secondary	Incident of tachyarrhythmia	Incident of ventricular tachycardia, ventricular fibrillation, Atrial fibrillation	upto 28 days