Идёт набор NCT05267886

CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

Фаза IV С лечением Shock, Cardiogenic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Dobutamine, Milrinone, Normal Saline.
Кому может быть актуально: Состояния в реестре: Shock, Cardiogenic. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

Cardiogenic shock (CS) is a state of inadequate end-organ perfusion due to cardiac dysfunction. Acute myocardial infarction (AMI) remains the most prevalent cause of CS, with mortality reaching upwards of 40% despite advances in emergent revascularization and accelerating use of mechanical circulatory support devices. International guidelines support the use of vasopressors and inotropes as a mainstay of medical therapy among this cohort of critically ill patients. Recently, the first head-to-head prospective randomized trial (CAPITAL DOREMI) comparing milrinone and dobutamine in a cohort of CS participants was performed and found no difference between agents.

There is a signal of harm associated with the use of inotropes in both acute, decompensated heart failure and in the longitudinal management of chronic heart failure. Inotrope use has also been associated with longer ICU and in-hospital length of stay, as well as higher in-hospital mortality. A recent network meta-analysis on treatment strategies in CS and found that while milrinone and dobutamine may reduce the risk of mortality compared to placebo, the evidence is of low certainty and the wide confidence intervals do not rule out the possibility of harm.

Despite their frequent use in the management of patients with CS, it remains unknown if inotropes are needed to augment successful initial resuscitation, reduce morbidity and mortality, or if they cause potential harm in this already critically ill patient population.

This study is a multi-centre, double blind, randomized controlled trial designed to examine the efficacy and safety of inotrope therapy against placebo in the initial resuscitation of SCAI class C to D cardiogenic shock. Consecutive patients admitted to an intensive care unit will be identified by the treating medical team as requiring new initiation of inotrope therapy for CS. All decisions to initiate inotrope therapy will be made by the primary care team with no involvement from the research team. The study hypothesis is that inotrope therapy will lead to an overall improvement in the primary outcome as compared to placebo.

Вмешательства

Препарат Dobutamine
Dobutamine administered according to its clinical dose stage for cardiogenic shock
Препарат Milrinone
Milrinone administered according to its clinical dose stage for cardiogenic shock
Препарат Normal Saline
Normal saline running at a standardized rate

Первичные конечные точки

Primary composite outcome [Срок оценки: Through duration of hospitalization, up to 12 weeks following admission]

Вторичные конечные точки (7)

All-cause in-hospital mortality [Срок оценки: Through duration of hospitalization, up to 12 weeks following admission]
Renal failure requiring new initiation of renal replacement therapy [Срок оценки: Through duration of hospitalization, up to 12 weeks following admission]
Need for cardiac transplant or mechanical circulatory support [Срок оценки: Through duration of hospitalization, up to 12 weeks following admission]
Atrial or ventricular arrhythmia leading to emergent electrical cardioversion [Срок оценки: Through duration of hospitalization, up to 12 weeks following admission]
Resuscitated cardiac arrest [Срок оценки: Through duration of hospitalization, up to 12 weeks following admission]
Non-fatal myocardial infarction [Срок оценки: Through duration of hospitalization, up to 12 weeks following admission]
Stroke or transient ischemic attack [Срок оценки: Through duration of hospitalization, up to 12 weeks following admission]

Критерии участия

Критерии включения

Adult patients ≥ 18 years of age admitted to an intensive care unit
SCAI class C or D cardiogenic shock

Критерии исключения

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
Severe obstructive valvular lesions, including aortic stenosis and/or mitral stenosis
Dynamic left ventricular outflow tract obstruction

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет