I48
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Critically ill patients admitted to the intensive care unit with new-onset tachyarrhythmia (in particular atrial fibrillation) with a clinical indication for rate control using landiolol as part of routine clinical care. - Presence of a clinical indication for advanced hemodynamic monitoring using transpulmonary thermodilution (PiCCO® system), including the requirement for central venous access for this purpose. - Ability to provide informed consent or presence of appropriate consent/legal representation.
Exclusion criteria
Exclusion criteria: - Patients under the age of 18 years. - Pregnant or breastfeeding women. - Known contraindications to beta-blockers (e.g., high-grade atrioventricular block without pacemaker, clinically relevant bradycardia). - Severe cardiogenic shock or hemodynamic instability in which beta-blocker therapy is contraindicated. - Inability to perform PiCCO® monitoring (e.g., absence of appropriate arterial or central venous access).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHAT: Change in cardiac index (CI) under treatment with landiolol in critically ill patients with new-onset atrial fibrillation. WHEN: Before initiation of landiolol therapy (T0) and during ongoing treatment under clinically stable conditions in the intensive care unit (T1, 30 minutes after the start of continuous landiolol infusion). HOW: Measurement of cardiac index using transpulmonary thermodilution as part of hemodynamic monitoring with the PiCCO® system (Pulse Contour Cardiac Output system). | — |
Secondary
| Measure | Time frame |
|---|---|
| WHAT: Changes in additional hemodynamic parameters, including mean arterial pressure (MAP), systemic vascular resistance index (SVRI), global end-diastolic volume index (GEDVI), and dynamic preload parameters such as stroke volume variation (SVV) or pulse pressure variation (PPV); heart rate reduction and achievement of rate control; changes in vasopressor requirements; lactate levels; and safety-related events including hypotension, bradycardia, and therapy discontinuation or escalation. WHEN: Before initiation of landiolol therapy (T0) and during ongoing treatment under clinically stable conditions in the intensive care unit (T1, 30 minutes after the start of continuous landiolol infusion). HOW: Hemodynamic parameters are assessed using transpulmonary thermodilution and pulse contour analysis (PiCCO® system). Heart rate and vasopressor requirements are recorded from continuous clinical monitoring and patient charts. Lactate levels are determined via standard laboratory blood analyses. Safety events are assessed through continuous clinical observation and documentation in the intensive care unit. | — |
Countries
Germany
Contacts
Gemeinschaftsklinikum Mittelrhein - Klinik für Intensivmedizin