UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037975 |
|---|---|
| Receipt number | R000043272 |
| Scientific Title | Association between carperitide infusion and shedding of the endothelial glydocalyx in non-cardiac surgery ICU patients |
| Date of disclosure of the study information | 2019/09/10 |
| Last modified on | 2022/09/13 14:26:10 |
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Basic information
Public title
Association between carperitide infusion and shedding of the endothelial glydocalyx in non-cardiac surgery ICU patients
Acronym
Carperitide infusion and shedding of the endothelial glycocalyx in non-cardiac surgery ICU patients
Scientific Title
Association between carperitide infusion and shedding of the endothelial glydocalyx in non-cardiac surgery ICU patients
Scientific Title:Acronym
Carperitide infusion and shedding of the endothelial glycocalyx in non-cardiac surgery ICU patients
Region
| Japan |
Condition
Condition
ICU patients except for post-cardiac surgery admittion who recieving carperitide infusion therapy
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients who start to receive carperitide infusion, parameters of sublingual microcirculation SDF-imaging analysis including Perfused Boundary Region (PBR), and plasma syndecan-1 concentration will be measured over time to investigate the shedding of glycocalyx associated to carperitide infusion.
Basic objectives2
Others
Basic objectives -Others
Shedding of endothelial glycocalyx associated to carperitide infusion
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in Perfused Boundary Region (PBR) [Time frame: just before the start of carperitide infusion, 1h, 2h, 6h after the start of infusion]
Key secondary outcomes
Change in plasma syndecan-1 concentration, RBC column width, RBC filling [Time frame: just before the start of carperitide infusion, 1h, 2h, 6h after the start of infusion]
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients (except for post-cardiac surgery admission to ICU) who scheduled to start carperitide infusion therapy in ICU.
Key exclusion criteria
1. A patient who have had recieved carperitide infusion within 12h
2. A patient with wobbly tooth
3. A patient with active bleeding in the mouth
4. A patient who have surgical history of tongue
5. A patient without any indwelling arterial line
6. A patient determined to be inappropriate as a research subject by the principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Saitoh |
Organization
Hokkaido University Hospital
Division name
Anesthesiology, ICU
Zip code
060-8648
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
kazuyuki_mizunoya@hotmail.com
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Mizunoya |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
060-8648
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
kazuyuki_mizunoya@hotmail.com
Sponsor or person
Institute
Hokkaido University Hospital
Anesthesiology, ICU
Institute
Department
Personal name
Funding Source
Organization
Selt funding
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
Hokkaido University Hospital Division of Clinical Research Administration
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Observation items:
Bacground, Physiological data (ex,vital signs), laboratory data, Glycocheck mesurements, serum syndecan-1 concentration, serum HANP concentration
Management information
Registered date
| 2019 | Year | 09 | Month | 10 | Day |
Last modified on
| 2022 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043272
