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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018653
Receipt No. R000021590
Scientific Title Effect of remote ischemic preconditioning(RIPC) on children undergoing cardiac surgery
Date of disclosure of the study information 2015/12/15
Last modified on 2015/08/12

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Basic information
Public title Effect of remote ischemic preconditioning(RIPC) on children undergoing cardiac surgery
Acronym Effect of remote ischemic preconditioning(RIPC) on children undergoing cardiac surgery
Scientific Title Effect of remote ischemic preconditioning(RIPC) on children undergoing cardiac surgery
Scientific Title:Acronym Effect of remote ischemic preconditioning(RIPC) on children undergoing cardiac surgery
Region
Japan

Condition
Condition Pediatric Patients undergoing cardiac surgery
Classification by specialty
Pediatrics Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of remote ischemic preconditioning(RIPC) on children undergoing cardiac surgery
by double-blind, randomized controlled study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Postoperative serum concentrations of troponin I(TnI)
Key secondary outcomes Perioperative serum concentrations of lactate dehydrogenase (LDH), creatine kinase(CK), and its isoenzyme(CKMB)
Inotropic score(IS)
Mechanical ventilation time

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 RIPC group:
RIPC is induced after induction of anesthesia and before skin incision.
Three 5-minute cycles of ischemia, achieved by inflation of a blood-pressure cuff to 30mmHg above the patient's systolic pressure, followed by 5-minute reperfusion while the cuff is deflated, are applied to the single leg.
Interventions/Control_2 Control group:
In controls, the cuff was placed around the leg but not inflated.
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
0 years-old <=
Age-upper limit
2 years-old >=
Gender Male and Female
Key inclusion criteria Pediatric patients who are scheduled to undergo cardiovascular surgery
with cardioplegic cardiac arrest under general anesthesia
Key exclusion criteria Newborns of less than 38 weeks' gestation,
children requiring mechanical ventilation,
children at risk for transient limb ischemia,
and children with severe heart failure using preoperative inotropic agents
are excluded
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoko Yamauchi
Organization Kanagawa children's medical center
Division name Department of Anesthesiology
Zip code
Address Mutsukawa 2-138-4, Minami-ku, Yokohama, Kanagawa, Japan
TEL +81-45-711-2351
Email kyouko-a@df6.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyoko Yamauchi
Organization Kanagawa children's medical center
Division name Department of Anesthesiology
Zip code
Address Mutsukawa 2-138-4, Minami-ku, Yokohama, Kanagawa, Japan
TEL +81-45-711-2351
Homepage URL
Email kyouko-a@df6.so-net.ne.jp

Sponsor
Institute Kanagawa children's medical center
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 神奈川県立こども医療センター Kanagawa children's medical center

Other administrative information
Date of disclosure of the study information
2015 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 Preinitiation
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 12 Day
Last modified on
2015 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021590

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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