UMIN-CTR Clinical Trial

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
Email	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
Email	kazuyuki_mizunoya@hotmail.com

Sponsor
Institute	Hokkaido University Hospital Anesthesiology, ICU
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043272