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Milrinone Versus Dobutamine in Critically Ill Patients

NCT03207165 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2020-06-30

No results posted yet for this study

Summary

The investigators are interested in determining if there is a meaningful difference between two of the most commonly used medications used to improve the pumping function of the heart among critically ill patients admitted to the Coronary Care Unit (CCU) at the University of Ottawa Heart Institute (UOHI). To do this, the investigators will randomly assign patients who are felt to require use of these medications by their treating physicians to one of the two most commonly used agents in Canada: Milrinone or Dobutamine. Each patient will be closely monitored by their healthcare team, and their medication will be adjusted based on each patient's clinical status. Information from blood work (e.g. kidney and liver function, complete blood counts, and other markers of how effectively blood is circulating in the body), assessment of end-organ function (e.g. urine output, mentation), abnormal heart rhythms noted on monitoring and results of imaging studies (e.g. angiogram, echocardiograms.) will be collected for analysis. All patients will be followed for the duration of their hospital stay at UOHI.

Conditions

  • Low Cardiac Output Syndrome
  • Cardiogenic Shock
  • Acute Coronary Syndrome
  • Pulmonary Edema

Interventions

DRUG

Milrinone

Patients will be initiated on Milrinone at 0.125 mcg/kg/min \[stage 1\] and will be titrated according to a blinded protocol from stages 2 to 5 \[0.250, 0.375, 0.5 and \>0.5 ug/kg/min\]. All orders to initiate and titrate the dose of the allocated inotrope will be written in the chart as follows: 'Study inotrope dose to be \[increased/decreased/maintained\] at stage \[1-5\]' so as to ensure that treating physicians remain blinded to the allocated drug.

DRUG

Dobutamine

Patients will be initiated on Dobutamine at 2.5 mcg/kg/min \[stage 1\] and will be titrated according to a blinded protocol from stages 2 to 5 \[5.0, 7.5, 10 and \>10 ug/kg/min\]. All orders to initiate and titrate the dose of the allocated inotrope will be written in the chart as follows: 'Study inotrope dose to be \[increased/decreased/maintained\] at stage \[1-5\]' so as to ensure that treating physicians remain blinded to the allocated drug.

Sponsors & Collaborators

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • Benjamin M Hibbert, MD, PhD · Ottawa Heart Institute Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-30
Primary Completion
2020-06-12
Completion
2020-06-12

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03207165 on ClinicalTrials.gov