Safety and efficacy of landiolol in controlling heart rate of supraventricular tachyarrhythmias in patients with severe sepsis

ISRCTN	ISRCTN70831305
DOI	https://doi.org/10.1186/ISRCTN70831305
Secondary identifying numbers	N/A

Submission date: 27/09/2013
Registration date: 10/12/2013
Last edited: 10/12/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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
masaki46228@m-kanazawa.jp

Contact information

Dr Masaki Okajima
Scientific

3-7 Takaramachi
Kanazawa
9200934
Japan

Phone	+812829990
Email	mmokaji@gmail.com

Study information

Study design	Historical cohort single-center inter-subjective comparison study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Safety and efficacy of landiolol in controlling heart rate of supraventricular tachyarrhythmias in patients with severe sepsis: a randomized controlled study
Study objectives	Landiolol can safely and effectively control heart rate of supraventricular tachyarrhythmias in patients with severe sepsis.
Ethics approval(s)	Innovative Clinical Research Center, Kanazawa University (iCREK); September/11/2009; Ref 5576
Health condition(s) or problem(s) studied	Supraventricular tachyarrhythmias with sepsis
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Landiolol
Primary outcome measure	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 study start date	11/09/2009
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	61
Key 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
Key exclusion criteria	1. Less than 18 years old 2. History of chronic supraventricular tachyarrhythmias 3. Supraventricular tachyarrhythmias at the time of ICU admission
Date of first enrolment	11/09/2009
Date of final enrolment	31/03/2012

Locations

Countries of recruitment

Japan

Study participating centre

3-7 Takaramachi

Kanazawa
9200934
Japan

Sponsor information

Kanazawa University Hospital (Japan)
Hospital/treatment centre

13-1, Takaramachi
Kanazawa
9200864
Japan

Phone	+81762652000
Email	medinfo@med.kanazawa-u.ac.jp
Website	http://web.hosp.kanazawa-u.ac.jp/
"ROR"	https://ror.org/00xsdn005

Funders

Funder type

Other

Investigator initiated and funded (Japan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan