Low-dose dobutamine in acute myocardial infarction with intermediate to high risk of cardiogenic shock development (the DOBERMANN-D trial): study protocol for a double-blinded, placebo-controlled, single-center, randomized clinical trial.
Humans
Dobutamine
/ administration & dosage
Shock, Cardiogenic
/ etiology
Double-Blind Method
Myocardial Infarction
Randomized Controlled Trials as Topic
Hemodynamics
/ drug effects
Natriuretic Peptide, Brain
/ blood
Biomarkers
/ blood
Peptide Fragments
/ blood
Treatment Outcome
Cardiotonic Agents
/ administration & dosage
Time Factors
Infusions, Intravenous
Risk Factors
Percutaneous Coronary Intervention
/ adverse effects
Risk Assessment
Acute myocardial infarction
Cardiogenic shock
Dobutamine
Hemodynamic
Inotropy
Neurohormonal activation
ORBI risk score
Percutaneous coronary intervention
Transthoracic echocardiography
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
30 Oct 2024
30 Oct 2024
Historique:
received:
09
07
2024
accepted:
18
10
2024
medline:
31
10
2024
pubmed:
31
10
2024
entrez:
31
10
2024
Statut:
epublish
Résumé
Cardiogenic shock (CS) occurs in 5-10% of patients with acute myocardial infarction (AMI), and the condition is associated with a 30-day mortality rate of up to 50%. Most of the AMI patients are in SCAI SHOCK stage B upon hospital arrival, but some of these patients will progression through the stages to overt shock (SCAI C-E). Around one third of patients who develop CS are not in shock at the time of hospital admission. Pro-B-type natriuretic peptide (proband) is a biomarker closely related to CS development. The aim of this study is to investigate the potential for preventing progression of hemodynamic instability by early inotropic support with low-dose dobutamine infusion administrated after revascularization in AMI patients with intermediate to high risk of in-hospital CS development. This investigator-initiated, double-blinded, placebo-controlled, randomized, single-center, clinical trial will include 100 AMI patients (≥ 18 years) without CS at hospital admission and at intermediate-high risk of in-hospital CS development (ORBI risk score ≥ 10). Patients will be randomized in a 1:1 ratio to a 24 h intravenous (IV) infusion of dobutamine (5 μg/kg/min) or placebo (NaCl) administrated after acute percutaneous coronary intervention (PCI) (< 24 h from symptom onset). Blood samples are drawn at time points from study inclusion (before infusion, 12, 24, 36, and 48 h). The primary outcome is peak plasma proBNP within 48 h after infusion as a surrogate-measure for the hemodynamic status. Hemodynamic function will be assessed pulse rate, blood pressure, and lactate within 48 h after infusion and by transthoracic echocardiography (TTE) performed after 24-48 h and at follow-up after 3 months. Markers of cardiac injury (troponin T and creatine kinase MB (CK-MB)) will be assessed. Early inotropic support with low-dose dobutamine infusion in patients with AMI, treated with acute PCI, and at intermediate-high risk of in-hospital CS may serve as an intervention promoting hemodynamic stability and facilitating patient recovery. The effect will be assessed using proBNP as a surrogate marker of CS development, hemodynamic measurements, and TTE within the initial 48 h and repeated at a 3-month follow-up. The Regional Ethics Committee : H-21045751. EudraCT: 2021-002028-19. gov: NCT05350592, Registration date: 2022-03-08. WHO Universal Trial Number: U1111-1277-8523.
Sections du résumé
BACKGROUND
BACKGROUND
Cardiogenic shock (CS) occurs in 5-10% of patients with acute myocardial infarction (AMI), and the condition is associated with a 30-day mortality rate of up to 50%. Most of the AMI patients are in SCAI SHOCK stage B upon hospital arrival, but some of these patients will progression through the stages to overt shock (SCAI C-E). Around one third of patients who develop CS are not in shock at the time of hospital admission. Pro-B-type natriuretic peptide (proband) is a biomarker closely related to CS development. The aim of this study is to investigate the potential for preventing progression of hemodynamic instability by early inotropic support with low-dose dobutamine infusion administrated after revascularization in AMI patients with intermediate to high risk of in-hospital CS development.
METHODS
METHODS
This investigator-initiated, double-blinded, placebo-controlled, randomized, single-center, clinical trial will include 100 AMI patients (≥ 18 years) without CS at hospital admission and at intermediate-high risk of in-hospital CS development (ORBI risk score ≥ 10). Patients will be randomized in a 1:1 ratio to a 24 h intravenous (IV) infusion of dobutamine (5 μg/kg/min) or placebo (NaCl) administrated after acute percutaneous coronary intervention (PCI) (< 24 h from symptom onset). Blood samples are drawn at time points from study inclusion (before infusion, 12, 24, 36, and 48 h). The primary outcome is peak plasma proBNP within 48 h after infusion as a surrogate-measure for the hemodynamic status. Hemodynamic function will be assessed pulse rate, blood pressure, and lactate within 48 h after infusion and by transthoracic echocardiography (TTE) performed after 24-48 h and at follow-up after 3 months. Markers of cardiac injury (troponin T and creatine kinase MB (CK-MB)) will be assessed.
DISCUSSION
CONCLUSIONS
Early inotropic support with low-dose dobutamine infusion in patients with AMI, treated with acute PCI, and at intermediate-high risk of in-hospital CS may serve as an intervention promoting hemodynamic stability and facilitating patient recovery. The effect will be assessed using proBNP as a surrogate marker of CS development, hemodynamic measurements, and TTE within the initial 48 h and repeated at a 3-month follow-up.
TRIAL REGISTRATION
BACKGROUND
The Regional Ethics Committee : H-21045751. EudraCT: 2021-002028-19.
CLINICALTRIALS
RESULTS
gov: NCT05350592, Registration date: 2022-03-08. WHO Universal Trial Number: U1111-1277-8523.
Identifiants
pubmed: 39478521
doi: 10.1186/s13063-024-08567-y
pii: 10.1186/s13063-024-08567-y
doi:
Substances chimiques
Dobutamine
3S12J47372
Natriuretic Peptide, Brain
114471-18-0
Biomarkers
0
Peptide Fragments
0
pro-brain natriuretic peptide (1-76)
0
Cardiotonic Agents
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
731Informations de copyright
© 2024. The Author(s).
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