UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044452 |
|---|---|
| Receipt number | R000050781 |
| Scientific Title | Usefulness of artificial endocrine pancreas with closed-loop glycemic control system in patients undergoing cardiovascular surgery: a prospective randomized controlled trial |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/06/06 21:24:10 |
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Basic information
Public title
Usefulness of artificial endocrine pancreas with closed-loop glycemic control system in patients undergoing cardiovascular surgery: a prospective randomized controlled trial
Acronym
LEAP study
Scientific Title
Usefulness of artificial endocrine pancreas with closed-loop glycemic control system in patients undergoing cardiovascular surgery: a prospective randomized controlled trial
Scientific Title:Acronym
LEAP study
Region
| Japan |
Condition
Condition
Cardiovascular diseases
Classification by specialty
| Cardiovascular surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of artificial pancreas therapy in patients undergoing cardiovascular surgery using cardiopulmonary bypass comparison with conventional glycemic control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Glycemic variability from intraoperative to postoperative day 3
Key secondary outcomes
Incidences of SSI and postoperative atrial fibrillation from postoperative to discharge
etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Conventional glycemic control in perioperative period
Interventions/Control_2
Glycemic control using artificial endocrine pancreas in perioperative period
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients slated for cardiovascular surgery using CPB
(2) Patients over 20 years old
(3) Elective surgery
Key exclusion criteria
(1) Patients on maintenance dialysis
(2) Patients with preoperative persistent atrial fibrillation
(3) Patients undergoing ventricular assist device
(4) Patients undergoing heart transplant
(5) Patients who are expected to stay in ICU for less than 2 days
(6) Patients with psychiatric disorders or cognitive impairment who are considered difficult to participate in the study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshikatsu |
| Middle name | |
| Last name | Saiki |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of cardiovascular surgery
Zip code
9818574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
0227177222
yoshisaiki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Konosuke |
| Middle name | |
| Last name | Sasaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Oncology Nursing
Zip code
9818575
Address
2-1, Seiryo-machi, Aoba-ku, Sendai
TEL
0227177928
Homepage URL
konosuke.s@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Review Board of Tohoku University Hospital.
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
Tel
0227284105
ec@rinri.hosp.tohoku.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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 06 | Day |
Last modified on
| 2021 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050781
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
