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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milrinone group | Experimental | 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. |
|
| Placebo group | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milrinone | Drug | Prepare milrinone 20 mg with NSS 100 ml then starts dose 0.5 mg/kg/min for up to 12 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive care unit (ICU) mortality | Proportion of participant who die during ICU admission | upto 120 days |
| Hospital mortality | Proportion of participant who die during hospital admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Surat Tongyoo, Doctor | Contact | +6624198534 | surat_Ty@yahoo.co.uk | |
| Suratee Chobngam, Doctor | Contact | +66807155065 | areefsu123@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Surat Tongyoo | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hat Yai Hospital | Recruiting | Hat Yai | Changwat Songkhla | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40138463 | Derived | Tongyoo S, Chobngam S, Yolsiriwat N, Jiranakorn C. Effects of adjunctive milrinone versus placebo on hemodynamics in patients with septic shock: a randomized controlled trial. Ann Med. 2025 Dec;57(1):2484464. doi: 10.1080/07853890.2025.2484464. Epub 2025 Mar 26. |
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Anonymous identification data will be prepared per request, after study publication 6 months.
6 months post study publication
Request to principal investigation, after protocal approval from ethical committee.
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D020105 | Milrinone |
| ID | Term |
|---|---|
| D000676 | Amrinone |
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 |
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Pharmacist who does not involve in patient enrollment nor treatment will prepared milrinone or placebo in the identical container, before the study drug will be given to patients, according to their treatment arm.
| upto 120 days |
| 28-day mortality | Proportion of participant who die during 28 days after enrollment | upto 28 days |
| Dose of vasopressor after intervention | present as vasopressor equivalent dose compare before and after intervention, and percent of decrease | upto 7 days |
| Lactate clearance | lactate level after and before intervention and percent clearance | upto 7 days |
| Mechanical ventilator free day | day of the patient does not use mechanical ventilator during admission | upto 28 days |
| Extracorporeal membrane oxygenation (ECMO) or Renal replacement therapy (RRT) | incident of initial ECMO or RRT | upto 28 days |
| Incident of tachyarrhythmia | Incident of ventricular tachycardia, ventricular fibrillation, Atrial fibrillation | upto 28 days |
| Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University | Recruiting | Bangkok | 10700 | Thailand |
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |