Condition category
Circulatory System
Date applied
27/09/2013
Date assigned
10/12/2013
Last edited
10/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
masaki46228@m-kanazawa.jp

Trial website

Contact information

Type

Scientific

Primary contact

Dr Masaki Okajima

ORCID ID

Contact details

3-7 Takaramachi
Kanazawa
9200934
Japan
+812829990
mmokaji@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Safety and efficacy of landiolol in controlling heart rate of supraventricular tachyarrhythmias in patients with severe sepsis: a randomized controlled study

Acronym

Study hypothesis

Landiolol can safely and effectively control heart rate of supraventricular tachyarrhythmias in patients with severe sepsis.

Ethics approval

Innovative Clinical Research Center, Kanazawa University (iCREK); September/11/2009; Ref 5576

Study design

Historical cohort single-center inter-subjective comparison study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 Fisher’s 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

Phase

Not Applicable

Drug names

Landiolol

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 Fisher’s exact test or the chi-square test as appropriate.

Overall trial start date

11/09/2009

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

61

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

11/09/2009

Recruitment end date

31/03/2012

Locations

Countries of recruitment

Japan

Trial participating centre

3-7 Takaramachi
Kanazawa
9200934
Japan

Sponsor information

Organisation

Kanazawa University Hospital (Japan)

Sponsor details

13-1
Takaramachi
Kanazawa
9200864
Japan
+81762652000
medinfo@med.kanazawa-u.ac.jp

Sponsor type

Hospital/treatment centre

Website

http://web.hosp.kanazawa-u.ac.jp/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

Publication citations

Additional files

Editorial Notes