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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044452
Receipt No. 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

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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
Email 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
Email konosuke.s@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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