Vernakalant is superior to Amiodarone and rate control alone in the acute conversion of recent onset atrial fibrillation (AF) in critically ill patients admitted to the medical ICU.
ID
Source
Brief title
Health condition
Critically ill patients admitted to the medical ICU with AF
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
• 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
Background summary
The primary goal of the study is to investigate the efficacy and safety of Vernakalant in the acute conversion of AF, as compared to Amiodarone and rate control alone, in critically ill patients admitted to the medical ICU.
Study objective
Vernakalant is superior to Amiodarone and rate control alone in the acute conversion of recent onset atrial fibrillation (AF) in critically ill patients admitted to the medical ICU.
Study design
Primary endpoint: 90 minutes Secondary endpoint: during admission at the medical ICU
Intervention
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:Administration of Vernakalant, Amiodarone or rate control (1:1:1) (n=150).
Sonja Postma
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262999
s.postma@diagram-zwolle.nl
Sonja Postma
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262999
s.postma@diagram-zwolle.nl
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<3 hr - Admission to medical or non-cardiac surgical ICU
- Age > 18 years
- Providing informed consent (if necessary by legally acceptable representative)
- Expected duration of admission > 48h
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4062 |
| NTR-old | NTR4213 |
| CCMO | NL46690.075.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON41549 |