Back to results

Milrinone Versus Placebo in Patients With Septic Shock

Primary Purpose

Septic Shock, Cardiac Output

Status

Recruiting

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Milrinone

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Milrinone, Septic shock, Cardiac output, Poor tissue perfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hat Yai HospitalRecruiting
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Milrinone group

Placebo group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intensive care unit (ICU) mortality

Proportion of participant who die during ICU admission

Hospital mortality

Proportion of participant who die during hospital admission

28-day mortality

Proportion of participant who die during 28 days after enrollment

Dose of vasopressor after intervention

present as vasopressor equivalent dose compare before and after intervention, and percent of decrease

Lactate clearance

lactate level after and before intervention and percent clearance

Mechanical ventilator free day

day of the patient does not use mechanical ventilator during admission

Extracorporeal membrane oxygenation (ECMO) or Renal replacement therapy (RRT)

incident of initial ECMO or RRT

Incident of tachyarrhythmia

Incident of ventricular tachycardia, ventricular fibrillation, Atrial fibrillation

Full Information

NCT ID

NCT05122884

First Posted

September 23, 2021

Last Updated

September 13, 2022

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT05122884

Brief Title

Milrinone Versus Placebo in Patients With Septic Shock

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock, Cardiac Output

Keywords

Milrinone, Septic shock, Cardiac output, Poor tissue perfusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Milrinone group

Arm Type

Experimental

Arm Description

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Milrinone

Other Intervention Name(s)

Primacor

Intervention Description

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

Primary Outcome Measure Information:

Title

The change of cardiac output from baseline (before study drug administration) to 6 hours (during study administration)

Description

by echocardiogram or Pulse contour analysis or Thermodilution technique from pulmonary artery catheter

Time Frame

upto 24 hours

Secondary Outcome Measure Information:

Title

Intensive care unit (ICU) mortality

Description

Proportion of participant who die during ICU admission

Time Frame

upto 120 days

Title

Hospital mortality

Description

Proportion of participant who die during hospital admission

Time Frame

upto 120 days

Title

28-day mortality

Description

Proportion of participant who die during 28 days after enrollment

Time Frame

upto 28 days

Title

Dose of vasopressor after intervention

Description

present as vasopressor equivalent dose compare before and after intervention, and percent of decrease

Time Frame

upto 7 days

Title

Lactate clearance

Description

lactate level after and before intervention and percent clearance

Time Frame

upto 7 days

Title

Mechanical ventilator free day

Description

day of the patient does not use mechanical ventilator during admission

Time Frame

upto 28 days

Title

Extracorporeal membrane oxygenation (ECMO) or Renal replacement therapy (RRT)

Description

incident of initial ECMO or RRT

Time Frame

upto 28 days

Title

Incident of tachyarrhythmia

Description

Incident of ventricular tachycardia, ventricular fibrillation, Atrial fibrillation

Time Frame

upto 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Surat Tongyoo, Doctor

Phone

+6624198534

surat_Ty@yahoo.co.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Suratee Chobngam, Doctor

Phone

+66807155065

areefsu123@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Surat Tongyoo

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hat Yai Hospital

City

Hat Yai

State/Province

Songkhla

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chutima Jiranakorn, doctor

Phone

+66815993377

waitfor027@gmail.com

Facility Name

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

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Surat Tongyoo, MD

Phone

+6624198534

surat_Ty@yahoo.co.uk

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymous identification data will be prepared per request, after study publication 6 months.

IPD Sharing Time Frame

6 months post study publication

IPD Sharing Access Criteria

Request to principal investigation, after protocal approval from ethical committee.

Learn more about this trial

Milrinone Versus Placebo in Patients With Septic Shock

We'll reach out to this number within 24 hrs