Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis

Tongji Hospital

Status: Unknown

Conditions: Fulminant Myocarditis

Study type: Observational

Funder types: Other

Identifiers

NCT03268642

TJH-C20160202

Details and patient eligibility

About

This is a retrospective cohort study to assess the clinical outcome of patients with fulminant myocarditis using "Life-support Based Comprehensive Treatment Regimen" and conventional therapy. In the present study, participants receive various treatment as part of routine medical care without any assignment of specific interventions to them. The process of treatment during hospitalization were recorded in medical chart and was reviewed by independent research personnel.

Enrollment: 150 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 16 years of age or older;

• Diagnosed as fulminant myocarditis:

  • Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury (TNI and CK-MB and BNP or NT-pro-BNP);
  • Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain, and/or syncope;
  • Image for cardiac injury: marked diffused reduction in left ventricle wall movement, with dramatically decreased left ventricle ejection fraction (LVEF) < 45%;
  • Cardiogenic shock, e.g., systolic blood pressure ≤90 mmHg or mean arterial pressure < 70mm Hg or a systolic blood pressure decrease > 40 mm Hg, which is associated with the signs of hypofusion: cyanosis, cold extremities, oliguria, and/or changes in mental status.

Exclusion criteria

• Also considering acute coronary syndrome but unable to perform coronary angiography to distinguish acute coronary syndrome from fulminant myocarditis;
• Myocardial injury caused by sepsis, chemotherapeutical agents, or poisons;
• Unstable hemodynamics or shock caused by hypovolemia.

Trial design

150 participants in 2 patient groups

Life-support Based Comprehensive Treatment Regimen group

Description:

meet all the following conditions: 1. intravenous immune globulin; 2. large dose of glucocorticoids; 3. mechanical ventilation; 4. hemodynamic support: intra-aortic balloon pump (IABP) or/and extracorporeal membrane oxygenation (ECMO); 5. continuous renal replacement therapy.

conventional therapy group

Description:

meet one of the following conditions: 1. without/insufficient intravenous immune globulin; 2. without/with various doses of glucocorticoid ; 3. vasoactive drug; 4. without/delayed mechanical ventilation; 5. without/delayed hemodynamic support; 6. without/delayed continuous renal replacement therapy.