UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055044 |
|---|---|
| Receipt number | R000062884 |
| Scientific Title | Factors Influencing Intraoperative Hemodynamic Variability in Transurethral Bladder Tumor Resection: Relationship with 5-aminolevulinic acid |
| Date of disclosure of the study information | 2024/07/22 |
| Last modified on | 2024/07/22 15:57:49 |
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Basic information
Public title
Factors Influencing Intraoperative Hemodynamic Variability in Transurethral Bladder Tumor Resection:
Relationship with 5-aminolevulinic acid
Acronym
5-Aminolevulinic Acid and Intraoperative Hemodynamics
Scientific Title
Factors Influencing Intraoperative Hemodynamic Variability in Transurethral Bladder Tumor Resection:
Relationship with 5-aminolevulinic acid
Scientific Title:Acronym
5-Aminolevulinic Acid and Intraoperative Hemodynamics in Transurethral Bladder Tumor Resection
Region
| Japan |
Condition
Condition
Bladder tumor
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To observe the intraoperative hemodynamic effects of preoperative administration of 5-aminolevulinic acid.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative time under 65 mmHg mean blood pressure during anesthesia
Key secondary outcomes
Cumulative time of mean blood pressure less than 55 mmHg during anesthesia
Cumulative time of mean blood pressure less than 60 mmHg during anesthesia
Amount of vasopressor used during anesthesia
Blood pressure/heart rate at admission, discharge, recovery room, immediately after discharge from recovery room, and the day after surgery
Incidence of postoperative complications
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent transurethral bladder tumor resection under spinal anesthesia at Osaka Metropolitan University Hospital between January 2020 and July 2023
Key exclusion criteria
1. Cases managed under general anesthesia (including cases in which general anesthesia was performed after induction of spinal anesthesia)
2. patients who underwent at least two transurethral resections of bladder tumors during the case selection period (exclude the second and subsequent procedures)
3. patients with ASA (American Society of Anesthesiologist) Physical Status more than 4
4. patients under 20 years old on the date of surgery
Target sample size
364
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Fujimoto |
Organization
Osaka Metropolitan University
Division name
Department of Anesthesiology, School of Medicine
Zip code
5458585
Address
1-4-3, Asahimachi, Abenoku, Osaka City, Osaka
TEL
0666452186
v21794t@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Fujimoto |
Organization
Osaka Metropolitan University
Division name
Department of Anesthesiology, School of Medicine
Zip code
5458585
Address
1-4-3, Asahimachi, Abenoku, Osaka City, Osaka
TEL
0666452186
Homepage URL
v21794t@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee at Osaka Metropolitan University Graduate School of Medicine and Osaka Metropolitan University Hospital
Address
6F Abeno Medix, 1-2-7 Asahimachi, Abenoku, Osaka City, Osaka
Tel
06-6645-3456
gr-a-knky-ethics@omu.ac.jp
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
大阪公立大学付属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
236
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational and laboratory items
The following items are existing information (medical information obtained as part of routine medical care).
(i) Basic patient information: age, gender, diagnosis, medical history, comorbidities, medications, blood pressure, heart rate, and oxygen saturation on admission, morning of surgery, and before leaving the hospital, and blood test results (hemoglobin concentration, serum creatinine, AST, total bilirubin, serum albumin) at preoperative visit
Intraoperative evaluation items: intraoperative blood pressure, heart rate, and oxygen saturation, cumulative time of mean blood pressure less than 65 mmHg, type and dose of intraoperative transfusion, intraoperative blood transfusion volume, blood loss, operation time, anesthesia time, type and dose of intraoperative drugs, spinal subarachnoid anesthesia level, presence of local anesthesia, intraoperative blood test (hemoglobin concentration)
(iii) Postoperative evaluation items: blood pressure, heart rate, and oxygen saturation on the day of surgery and the day after, presence of postoperative complications (renal dysfunction, hepatic dysfunction, delirium, nausea and vomiting), blood tests (hemoglobin concentration, serum creatinine, AST, total bilirubin, serum albumin) the day after surgery
Management information
Registered date
| 2024 | Year | 07 | Month | 22 | Day |
Last modified on
| 2024 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062884
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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