UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032763
Receipt number R000037371
Scientific Title Clearance of cannabinoids during blood purification therapy for septic shock: A prospective observational study
Date of disclosure of the study information 2018/06/01
Last modified on 2020/06/01 15:17:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Clearance of cannabinoids during blood purification therapy for septic shock: A prospective observational study

Acronym

Clearance of cannabinoids during blood purification therapy for septic shock: A prospective observational study

Scientific Title

Clearance of cannabinoids during blood purification therapy for septic shock: A prospective observational study

Scientific Title:Acronym

Clearance of cannabinoids during blood purification therapy for septic shock: A prospective observational study

Region

Japan


Condition

Condition

septic shock

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the dynamics of mediators such as cannabinoids (CBs) by adsorption type of blood purification therapy for the patients with septic shock.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clearance of various analytes at each measurement time

Key secondary outcomes

Changes in various analyte concentrations over time, the length of ICU stays, the period of ventilator days, 28-day survival rate, 60-day survival rate


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 who undergo blood purification therapy with septic shock

Key exclusion criteria

Patients who are under 20 years old, those who didn't obtain informed consent, the cases with the estimated death within 24 hours and with the contraindication for anticoagulant use.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Masuda

Organization

Sapporo Medical University School of Medicine

Division name

Department of Intensive Care Medicine

Zip code


Address

South1 West16, Chuo-ku, Sapporo

TEL

011-611-2111

Email

miminekko@me.com


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiki Masuda

Organization

Sapporo Medical University School of Medicine

Division name

Department of Intensive Care Medicine

Zip code


Address

South1 West16, Chuo-ku, Sapporo

TEL

011-611-2111

Homepage URL


Email

miminekko@me.com


Sponsor or person

Institute

Sapporo Medical University
School of Medicine
Department of Intensive Care Medicine

Institute

Department

Personal name



Funding Source

Organization

Sapporo Medical University

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



Other administrative information

Date of disclosure of the study information

2018 Year 06 Month 01 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

Enrolling by invitation

Date of protocol fixation

2018 Year 05 Month 01 Day

Date of IRB

2017 Year 06 Month 08 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We will analyze relevant factors by collecting data in the future.


Management information

Registered date

2018 Year 05 Month 29 Day

Last modified on

2020 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037371


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name