UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018653 |
|---|---|
| Receipt number | 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 19:13:06 |
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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
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
kyouko-a@df6.so-net.ne.jp
Sponsor or person
Institute
Kanagawa children's medical center
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
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
Value
https://center6.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 | |
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| Registered date | File name |
