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A prospective, randomized, double- blind, placebo- controlled study to evaluate the efficacy of Landiolol hydrochloride for prevention of atrial fibrillation in patients undergoing cardiac surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518950-17-00
Acronym
Version: 2.1
Enrollment
164
Registered
2025-01-27
Start date
2021-10-18
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta-blocker intake, Normal left ventricular ejection fraction, Sinus rhythm

Brief summary

The primary end point is a combined endpoint consisting of the occurrence of atrial fibrillation and mortality during the initial 72 hours period after surgery.

Detailed description

Occurrence of atrial fibrillation during the initial seven days after surgery • Initiation of standard of care for atrial fibrillation because of postoperative atrial fibrillation • Hemodynamic stability assessed by systolic blood pressure, diastolic blood pressure, and heart rate (in patients on pacing, the pacemaker will be stopped before measurement of blood pressure and heart rate) at time of admission to the intensive care unit (ICU), at 24, 48 and 72 hours and 7 days after administr

Interventions

DRUGIsotone Natriumchloridlösung 0.9% Braun Injektionslösung Isotone Kochsalzlösung 0
DRUG9 % von BBraun BBraun Isotone Kochsalzlösung NaCl 0
DRUG9 % - in der praktischen Ecoflac® Plus PE-Flasche BBraun Isotone Kochsalzlösung 0
DRUG9 % Produktmerkmale: - Isotone Kochsalzlösung 0
DRUG9% - In der ecoflac® plus PE-Flasche - mit 2 Einstechmöglichkeiten und Aufhängung am Flaschenboden - kann an allen gängigen Infusionsständern befestigt werden - in verschiedenen Größen erhältlich Anwendungsgebiete: - Trägerlösung für Elektrolytkonzentrate und kompatible Medikamente - Flüssigkeits- und Elektrolytsubstitution bei hypochlorämischer Alkalose - Chloridverluste - kurzfristiger intravasaler Volumenersatz - hypotone Dehydratation - zur Wundbehandlung und zur Befeuchtung von Tüchern und
DRUG0 g Natriumchlorid. Der sonstige Bestandteil ist Wasser für Injektionszwecke. Wirkstoffe: Natriumchlorid
DRUGNatrium-Ion
DRUGChlorid

Sponsors

Medical University Of Vienna
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary end point is a combined endpoint consisting of the occurrence of atrial fibrillation and mortality during the initial 72 hours period after surgery.

Secondary

MeasureTime frame
Occurrence of atrial fibrillation during the initial seven days after surgery • Initiation of standard of care for atrial fibrillation because of postoperative atrial fibrillation • Hemodynamic stability assessed by systolic blood pressure, diastolic blood pressure, and heart rate (in patients on pacing, the pacemaker will be stopped before measurement of blood pressure and heart rate) at time of admission to the intensive care unit (ICU), at 24, 48 and 72 hours and 7 days after administr

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026