Critically ill patients admitted to the medical ICU with AF
Conditions
Interventions
Part A: no interventions are performed. Part A is a prospective observational cohort study meant to investigate the association between stress hormone levels and onset of AF (n=210).
Part B:Administr
Sponsors
Isala Zwolle
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria Part A: - Admission to medical ICU - Expected duration of admission > 48h - Age > 18 years - Providing informed consent (if necessary by legally acceptable representative) Additional inclusion criteria Part B: - New onset AF 18 years - Providing informed consent (if necessary by legally acceptable representative) - Expected duration of admission > 48h
Exclusion criteria
Exclusion criteria: Exclusion criteria Part A (any of the following): • AF on admission • Inability to collect blood samples or 24 hour urine • Major structural cardiac disease as revealed by transthoracic echocardiography (TTE) • Administration of corticosteroids during or prior to admission • Any disease affecting corticosteroid, renine, aldosterone or catecholamine hormone production (eg.: Cushing-, Addisone-, Conn disease, Reninoma, Pheochromocytoma) Exclusion criteria Part B (any of the following): • AF on admission • Hemodynamically unstable AF (systolic RR<60 mmHg or signs of systemic hypoperfusion) • Atrial Flutter (Afl) • Conversion to sinus rhythm before randomization • Major structural cardiac disease as revealed by TTE • Contraindication against Vernakalant • Contraindication against Amiodarone • Acute coronary syndrome (ACS) • Major, incorrigible electrolyte disturbances • Administration of Amiodarone within 3 months prior to inclusion • Being under active anti-arrhythmic treatment, other than conventional beta-blocker or digoxine • Pregnancy or breast feeding - Acute decompensated heart failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of critically ill patients admitted to the medical ICU demonstrating conversion to sinus rhythm (SR) from AF within 90 minutes of first exposure to the study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Secondary endpoint: Association between stress hormonal markers and onset of AF in critically ill patients admitted to the medical ICU in a maximal period of one week after admission. • Tertiary endpoints: o Correlation between success rate of pharmacologic conversion and stress hormone levels in critically ill patients admitted to the medical ICU. o All cause mortality in the three treatment groups. o All cause mortality comparing rhythm control to rate control o Duration of hospitalization comparing rhythm control to rate control o Frequency of acute cerebral or peripheral ischemic events comparing rhythm control to rate control o Proportion of critically ill patients admitted to the medical ICU maintaining SR after successful initial conversion at 24 hours. • Safety endpoints: o Nature, frequency, severity and relationship to treatment of adverse events | — |
Contacts
Public ContactSonja Postma
Dokter Stolteweg 96
Outcome results
None listed