Milrinone Versus Placebo in Patients With Septic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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

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Septic Shock Cardiac Output

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Milrinone group

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.

Group Type EXPERIMENTAL

Milrinone

Intervention Type DRUG

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Milrinone

Intervention Type DRUG

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

Interventions

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Milrinone

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

Intervention Type DRUG

Other Intervention Names

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Primacor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No