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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043272


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name