Septic ShockPhase 2NCT05122884
Milrinone Versus Placebo in Patients With Septic Shock
A Phase 2 study testing Milrinone in people with Septic Shock and Cardiac Output, run by Mahidol University at 2 sites in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Cardiac Output
- What is being tested?
- Milrinone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Dec 2021to Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 %
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Surat Tongyoo, MD, +6624198534, surat_Ty@yahoo.co.uk
- Recruiting
Hat Yai Hospital
Hat Yai, Changwat Songkhla, 10700
Chutima Jiranakorn, doctor, +66815993377, waitfor027@gmail.com
About this study
Official title: Effect of Milrinone Versus Placebo on Hemodynamics in Patients With Septic Shock; Randomized Control Trial
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.
Read the 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.
- Conditions
- Septic Shock, Cardiac Output
- Being tested
- Milrinone
- Keywords
- Milrinone, Septic shock, Cardiac output, Poor tissue perfusion
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilrinoneDrug
Also called Primacor
Prepare milrinone 20 mg with NSS 100 ml then starts dose 0.5 mg/kg/min for up to 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Milrinone |
| 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 Receives: Drug: Milrinone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: upto 24 hours
Secondary outcomes (8)
Intensive care unit (ICU) mortality
Proportion of participant who die during ICU admission
Measured: upto 120 days
Hospital mortality
Proportion of participant who die during hospital admission
Measured: upto 120 days
28-day mortality
Proportion of participant who die during 28 days after enrollment
Measured: upto 28 days
Dose of vasopressor after intervention
present as vasopressor equivalent dose compare before and after intervention, and percent of decrease
Measured: upto 7 days
Lactate clearance
lactate level after and before intervention and percent clearance
Measured: upto 7 days
Mechanical ventilator free day
day of the patient does not use mechanical ventilator during admission
Measured: upto 28 days
Extracorporeal membrane oxygenation (ECMO) or Renal replacement therapy (RRT)
incident of initial ECMO or RRT
Measured: upto 28 days
Incident of tachyarrhythmia
Incident of ventricular tachycardia, ventricular fibrillation, Atrial fibrillation
Measured: upto 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Dec 2021
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Surat Tongyoo, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122884
- Sponsor's protocol ID
- SI 111/2021
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2021
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous identification data will be prepared per request, after study publication 6 months.
Publications
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.
PubMed 40138463
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Milrinone Versus Placebo on Hemodynamics in Patients With Septic Shock; Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05122884
- Acronym / sponsor ID
- SI 111/2021
- Conditions
- Septic Shock, Cardiac Output
- Keywords
- Milrinone, Septic shock, Cardiac output, Poor tissue perfusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milrinone group | Experimental | Drug: MilrinoneThe 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 | Drug: MilrinoneThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MilrinoneAlso: PrimacorPrepare milrinone 20 mg with NSS 100 ml then starts dose 0.5 mg/kg/min for up to 12 hours. | Drug | Milrinone group, Placebo group |
Primary outcome
The change of cardiac output from baseline (before study drug administration) to 6 hours (during study administration)
Time frame: upto 24 hours
by echocardiogram or Pulse contour analysis or Thermodilution technique from pulmonary artery catheter
8 secondary outcomes
Intensive care unit (ICU) mortality
Time frame: upto 120 days
Hospital mortality
Time frame: upto 120 days
28-day mortality
Time frame: upto 28 days
Dose of vasopressor after intervention
Time frame: upto 7 days
Lactate clearance
Time frame: upto 7 days
Mechanical ventilator free day
Time frame: upto 28 days
Extracorporeal membrane oxygenation (ECMO) or Renal replacement therapy (RRT)
Time frame: upto 28 days
Incident of tachyarrhythmia
Time frame: upto 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Derived from this study: PubMed 40138463Tongyoo 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.
- Individual participant dataSharing planned: Yes. Anonymous identification data will be prepared per request, after study publication 6 months.
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surat Tongyoo principal investigator
Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Milrinone in people with Septic Shock and Cardiac Output, run by Mahidol University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Surat Tongyoo, Doctor (+6624198534, surat_Ty@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of cardiac output from baseline (before study drug administration) to 6 hours (during study administration) (time frame: upto 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05122884, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.