CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock
ConditionShock, Cardiogenic
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation
About this trial
The investigators are interested in determining if there is a meaningful benefit from the use of medications purported to increase the pumping function of the heart (i.e. inotropes) among critically ill patients admitted to the Cardiac Intensive Care Unit (CICU). To do this, the investigators will conduct a multi-centre, double blind, randomized control trial with patients who are deemed to require these medications by their treating physician to one of the two most commonly used agents in Canada (Milrinone or Dobutamine) or placebo. Each patient will be closely monitored by their healthcare team. The dose of medication will be adjusted according to each patients' clinical status. After 12 hours, the participants will move to open label treatment and any continued use of inotropes will be at the discretion of their treating physician.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients ≥ 18 years of age admitted to an intensive care unit
SCAI class C or D cardiogenic shock
Disqualifiers
Unwilling or unable to obtain informed consent by the participant or substitute decision maker
Patients who are currently pregnant or breast-feeding
Patients presenting with an out-of-hospital cardiac arrest (OHCA)
Administration of milrinone or dobutamine in the 24 hours preceding anticipated randomization
Trial design
Design model
Parallel
Treatments tested in this trial
Dobutamine
DrugDobutamine administered according to its clinical dose stage for cardiogenic shock
Milrinone
DrugMilrinone administered according to its clinical dose stage for cardiogenic shock
Normal Saline
DrugNormal saline running at a standardized rate
Treatment groups
346 Participants
are divided into 2 treatment groupsGroup A: InotropeActive comparator 2 interventions
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary composite outcome
The primary outcome will be a composite of: 1. All-cause mortality during the hospitalization 2. Measured within the first 12 hours of starting the study intervention, any of: 1. Sustained hypotension (mean arterial pressure ≤55mmHg) or sustained requirement of high dose vasopressors (norepinephrine \>0.2 mcg/kg/min or norepinephrine 0.2 mcg/kg/min plus any additional agent) with any escalation in dose from time of randomization, for \>/= 60 minutes 2. Lactate greater than 3.5 mmol/L at 6 hours or thereafter 3. Need for mechanical circulatory support device 4. Atrial or ventricular arrhythmia leading to emergent electrical cardioversion 5. Resuscitated cardiac arrest
Time frame
Through duration of hospitalization, up to 12 weeks following admissionSecondary outcomes
1
All-cause in-hospital mortality
Death resulting from any cause during hospitalization
Time frame
Through duration of hospitalization, up to 12 weeks following admission2
Renal failure requiring new initiation of renal replacement therapy
Requiring new initiation of renal replacement therapy
Time frame
Through duration of hospitalization, up to 12 weeks following admission3
Need for cardiac transplant or mechanical circulatory support
Identification of needing a cardiac transplant or mechanical circulatory support
Time frame
Through duration of hospitalization, up to 12 weeks following admission4
Atrial or ventricular arrhythmia leading to emergent electrical cardioversion
Requiring emergent electrical cardioversion for atrial or ventricular arrhythmia
Time frame
Through duration of hospitalization, up to 12 weeks following admissionOther outcomes
1
Need for non-invasive or invasive mechanical ventilation
Need for non-invasive or invasive mechanical ventilation after randomization
Time frame
Through duration of hospitalization, up to 12 weeks following admission2
Arrhythmia requiring pharmacologic intervention
Atrial or ventricular arrhythmias requiring initiation of pharmacologic intervention (intravenous or oral anti-arrhythmic therapy)
Time frame
Through duration of hospitalization, up to 12 weeks following admission3
Acute kidney injury
Acute kidney injury
Time frame
Through duration of hospitalization, up to 12 weeks following admissionSponsors and contacts
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Source ClinicalTrials.gov