UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000945 |
|---|---|
| Receipt number | 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 11:07:06 |
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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
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
drjkawa@naramed-u.ac.jp
Sponsor or person
Institute
The Intraoperative Landiolol for Intracranial Aneurysm Surgery Trials Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001056
