Milrinone Versus Placebo in Patients With Septic Shock

NCT05122884 | Unknown Phase 2

• 1 other identifier: SI 111/2021
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Septic Shock; Cardiac Output

Keywords

Milrinone; Septic shock; Cardiac output; Poor tissue perfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Intensive care unit (ICU) mortality

  upto 120 days

• Hospital mortality

  upto 120 days

• 28-day mortality

  upto 28 days

• Dose of vasopressor after intervention

  upto 7 days

• Lactate clearance

  upto 7 days

Study Arms (2)

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.

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

Drug: Milrinone

Interventions

Milrinone DRUG

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

Milrinone group; Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 %

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (2)

Hat Yai Hospital

Hat Yai, Changwat Songkhla, 10700, Thailand

RECRUITING

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

Related Publications (1)

• 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.

  PMID: 40138463 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Milrinone

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Amrinone; Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Surat Tongyoo

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Surat Tongyoo, Doctor

CONTACT

+6624198534; surat_Ty@yahoo.co.uk

Suratee Chobngam, Doctor

CONTACT

+66807155065; areefsu123@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: November 17, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 6 months post study publication
• Access Criteria: Request to principal investigation, after protocal approval from ethical committee.

Locations

TH (2)