Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction

Обзор

Rationale: Pump failure due to acute myocardial infarction (AMI) can lead to cardiogenic shock (CS): a state of low blood flow to end-organs with subsequent multi-organ failure that is associated with high mortality rated. The first line pharmacologic treatment strategy in CS is noradrenaline. This vasopressor drug is used to maintain adequate blood pressures. The assumption is that a mean arterial blood pressure (MAP) ≥ 65 mmHg will improve flow and thereby tissue perfusion of myocardium and other tissues (e.g. renal). However, there is no evidence that an increase in MAP, if achieved by noradrenaline, leads to greater end-organ blood flow and better outcomes. Objective: With this study the investigators aim to investigate the (cost-)effectiveness of reduced noradrenaline in patients with CS by using a lower MAP target of ≥ 55 mmHg, compared to ≥ 65 mmHg. The investigators hypothesize that reduced use of noradrenaline will improve overall survival and decrease renal failure requiring renal replacement therapy. Study design: Open label, randomized controlled multicenter trial Study population: Adults patients with CS due to AMI Intervention: Treatment strategy of reduced noradrenaline, by using a lower MAP target ( ≥ 55 mmHg). Main study endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization.

Вмешательства

• Препарат Reduced noradrenaline use
  Reduced noradrenaline by using a lower MAP target

Первичные конечные точки

• Mortality and renal failure [Срок оценки: 30-days]

Вторичные конечные точки (10)

• Blood pressure (systolic and diastolic) [Срок оценки: The first 24 hours]
• Heart rate [Срок оценки: The first 24 hours]
• Enzymatic infarct size, measured by hs-Troponin T [Срок оценки: 0, 6, 12, 24, 36 and 72 hours]
• Enzymatic infarct size, measured by CK-MB [Срок оценки: 0, 6, 12, 24, 36 and 72 hours]
• Need for mechanical circulatory support [Срок оценки: Recorded after ICU/CCU discharge, assessed up to 60 days]
• Duration of mechanical ventilation [Срок оценки: Recorded after ICU/CCU discharge, assessed up to 60 days]
• Need for vasopressors / inotropes [Срок оценки: Recorded after ICU/CCU discharge, assessed up to 60 days]
• Ejection fraction, percent [Срок оценки: 72 hours and 1 year]
• Renal function [Срок оценки: 1 year]
• Cost-effectiveness [Срок оценки: 1-year]

Критерии участия

Критерии включения

• Acute myocardial infarction, STEMI or NSTEMI
• Early revascularization by PCI
• Cardiogenic shock, characterized by:

I. a. Systolic blood pressure (SBP) ≤ 90 mmHg for > 30 minutes, OR b. Use of drugs to maintain SBP > 90 mmHg at randomization.

II. Clinical signs of impaired organ perfusion with at least one of the following criteria:

• Altered mental status
• Cold, clammy skin and extremities
• Oliguria with urine output < 30ml/hour
• Serum lactate > 2.0 mmol/L

III. Clinical signs of pulmonary congestion

Критерии исключения

• Resuscitation > 30 minutes
• Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture)
• Onset of shock > 12 hours
• Imminent need for mechanical circulatory support (i.e. ECPR)
• Women <45 years

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Amsterdam UMC, location AMC — Amsterdam

Идентификаторы

NCT: NCT05168462 · NL79416.018.21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗