Plain English Summary
Background and study aim
Supraventricular tachyarrhythmias (abnormal heart rhythm when the heart beats faster) are frequently observed in patients with sepsis. The incidence of paroxysmal atrial fibrillation/flutter (PAF) has been reported to be 31% in critically ill patients with sepsis. Tachyarrhythmias have been identified as a major source of morbidity in critically ill patients. Therefore, controlling tachyarrhythmia is important in such patients. Drugs used to control the heart rate include beta-blockers. The aim of this study is to assess if a drug called landiolol can safely and effectively control heart rate of supraventricular tachyarrhythmias in patients with severe sepsis.
Who can participate?
All patients admitted to the intensive care unit (ICU) of the Kanazawa University Hospital from January 2006 to December 2011.
What does the study involve?
Patients were randomly allocated to one of two groups: those treated with landiolol (landiolol group) and those not treated with landiolol (control group).
What are the possible benefits and risks of participating?
The possible benefit is that patients can get hemodynamic stabilization. On the other hand, the possible risks are bradycardia (slower than usual heart beat) and shock. Should that happen, we stop giving landiolol to participants.
Where is the study run from?
Intensive Care Unit in Kanazawa University Hospital (Japan)
When is the study starting and how long is it expected to run for?
From January 2006 to December 2011.
Who is funding the study?
Investigator initiated and funded and no external funding (Japan)
Who is the main contact?
Dr. Masaki Okajima
Dr Masaki Okajima
Safety and efficacy of landiolol in controlling heart rate of supraventricular tachyarrhythmias in patients with severe sepsis: a randomized controlled study
Landiolol can safely and effectively control heart rate of supraventricular tachyarrhythmias in patients with severe sepsis.
Innovative Clinical Research Center, Kanazawa University (iCREK); September/11/2009; Ref 5576
Historical cohort single-center inter-subjective comparison study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Supraventricular tachyarrhythmias with sepsis
Patients were divided into two groups: those treated with landiolol (landiolol group) and those not treated with landiolol (control group) to control HR of supraventricular tachyarrhythmias.
Patient characteristics and hemodynamics of the two groups were compared using an independent t-test for continuous variables and with either Fishers exact test or a chi-square test for categorical variables. Other data were analyzed by repeated-measures analysis of variance. In all analyses, p < 0.05 was considered statistically significant.
Primary outcome measures
HR reduction of the supraventricular tachyarrhythmias without a decrease in arterial pressure. Arterial pressure and HR were compared between the two groups at 1, 8, and 24 h after the initiation of tachyarrhythmia.
Secondary outcome measures
The frequency of conversion to sinus rhythm. Differences of conversion rates were analyzed with Fishers exact test or the chi-square test as appropriate.
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. All patients who admitted to intensive care unit of the Kanazawa University Hospital from January 2006 to December 2011
2. Systemic inflammatory response syndrome score ≥ 2 with infection
3. Supraventricular tachyarrhythmias with HR ≥ 120 bpm for >1 h
Target number of participants
Participant exclusion criteria
1. Less than 18 years old
2. History of chronic supraventricular tachyarrhythmias
3. Supraventricular tachyarrhythmias at the time of ICU admission
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Investigator initiated and funded (Japan)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting