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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000945
Receipt No. R000001056
Scientific Title The Intraoperative Landiolol for Intracranial Aneurysm Surgery Trials
Date of disclosure of the study information 2007/12/15
Last modified on 2009/02/26

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Basic information
Public title The Intraoperative Landiolol for Intracranial Aneurysm Surgery Trials
Acronym ILAST
(The Intraoperative Landiolol for Intracranial Aneurysm Surgery Trials)
Scientific Title The Intraoperative Landiolol for Intracranial Aneurysm Surgery Trials
Scientific Title:Acronym ILAST
(The Intraoperative Landiolol for Intracranial Aneurysm Surgery Trials)
Region
Japan

Condition
Condition Tachyarrhythmia
Classification by specialty
Anesthesiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of perioperative landiolol hydrochloride on symptoms involving increased sympathetic nerve abnormality (tachyarrhythmia, abnormal electrocardiogram, myocardial dysfunction, cardiac disturbance and hypercytokinemia) and tissue damage after ruptured intracranial aneurysms surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The incidence of cardiovascular event
Key secondary outcomes Heart rate
Plasma cytokine
Markers of tissue damage (blood nitrotyrosine, urine 80HdG, S100-beta)
Incidence of delayed ischemic neuronal deficits
Neurological prognosis after three months

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Landiolol hydrochloride is continuously administered during the operation.
Heart rate is maintained betweeb 60 and 80bpm.
Interventions/Control_2 Landiolol hydrochloride is not used regardless of any heart rate.
If necessary, other drugs such as diltiazem hydrochloride are allowed to use.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients undergoing ruptured intraclanial aneurysm surgery.
2. The interval from the onset of symptoms until the operation is less than 48 hours.
3.Heart rate is 90 or more beats per minute before the operation.
Key exclusion criteria 1.Patients with a cardiogenic shock, congestive heart failure, or hypotension (systolic blood pressure less than 90 mmHg, more than 30 minutes)
2. Patients with a diabetic ketoacidosis, or serious metabolic acidosis(BE equal or less than -10)
3. Patients with an atrioventricular block (the degree of II or III) or sick sinus syndrome.
4. Pregnant.
5. Patients with preoperative poor neurological score(Hunt and Kosnik grade 5).
6. Patients with a renal failure or undergoing hemodialysis.
7. Patients with a severe hepatic insufficiency.
8. Patients with severe obesity(body mass index equal or more than 35).
9. Patients with an immunodeficiency or medicated with the immunosuppressant.
10. Patients with an infection, such as a hepatitis B virus, a hepatitis C virus or human immunodeficiency virus, before the operation
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takefumi Sakabe
Organization Yamaguchi University School of Medicine
Division name Department of Anesthesiology-Resuscitology
Zip code
Address 1-1-1 Minami-kogushi Ube, Yamaguchi
TEL 0836-22-2291
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Kawaguchi
Organization Nara Medical University
Division name Department of Anesthesiology
Zip code
Address 840 Shijo-cho Kashihara, Nara, Japan
TEL 0744-29-8902
Homepage URL https://homepage1.nifty.com/MORIMO/ilast/index.html
Email drjkawa@naramed-u.ac.jp

Sponsor
Institute The Intraoperative Landiolol for Intracranial Aneurysm Surgery Trials Group
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2004 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 01 Month 01 Day
Last follow-up date
2008 Year 08 Month 01 Day
Date of closure to data entry
2008 Year 08 Month 01 Day
Date trial data considered complete
2008 Year 10 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 12 Month 11 Day
Last modified on
2009 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001056

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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