Comparing Milrinone to Placebo for Septic Shock Treatment
Effect of Milrinone Versus Placebo on Hemodynamics in Patients With Septic Shock; Randomized Control Trial
This study is testing if milrinone can help improve heart function and recovery in patients with septic shock who haven't responded well to fluids.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 2 sites (Hat Yai, Songkhla and 1 other locations) |
| Trial ID | NCT05122884 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of milrinone compared to a placebo in patients suffering from septic shock, a severe condition characterized by poor tissue perfusion and potential multi-organ failure. The study focuses on patients who have undergone fluid resuscitation and still exhibit signs of inadequate cardiac output. By evaluating the impact of milrinone on cardiac function and overall patient outcomes, the trial aims to provide insights into alternative treatment options for septic shock. The research is being conducted in intensive care units at two hospitals in Thailand.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with septic shock who have not responded adequately to initial resuscitation efforts.
Not a fit: Patients with chronic kidney disease stage 5 or those who are terminally ill may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option that improves cardiac output and survival rates in patients with septic shock.
How similar studies have performed: While there have been few studies on milrinone in septic shock, the approach remains relatively novel and underexplored compared to traditional treatments like dobutamine.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hat Yai, Songkhla and 1 other locations
- Hat Yai Hospital — Hat Yai, Songkhla, Thailand (Recruiting)
- Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Surat Tongyoo — Mahidol University
- Study coordinator: Surat Tongyoo, Doctor
- Email: surat_Ty@yahoo.co.uk
- Phone: +6624198534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.