UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035179
Receipt number R000040099
Scientific Title Evaluation on CRRT termination of death cases in ICU
Date of disclosure of the study information 2018/12/08
Last modified on 2018/12/08 16:14:08

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Basic information

Public title

Evaluation on CRRT termination of death cases in ICU

Acronym

Evaluation on CRRT termination

Scientific Title

Evaluation on CRRT termination of death cases in ICU

Scientific Title:Acronym

Evaluation on CRRT termination

Region

Japan


Condition

Condition

Diseases requiring CRRT such as sepsis, acute renal injury, acute liver failure, severe acute pancreatitis

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The timing of CRRT termination at the terminal stage of cases judged to be life saving in ICU will be examined from death cases.

Basic objectives2

Others

Basic objectives -Others

End-of-life ethics

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time from CRRT termination to death

Key secondary outcomes

The days of CRRT duration, timing of CRRT ending and its situation


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


 Not applicable

Age-upper limit


 Not applicable

Gender

Male and Female

Key inclusion criteria

Among CRRT patients who stayed at our hospital ICU for more than 7 days, patients died of ICU

Key exclusion criteria

none

Target sample size

65


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroomi Tatsumi

Organization

Sapporo Meedical University School of Medicine

Division name

Department of Intensive Care Medicine

Zip code


Address

South 1 West 16, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Email

htatsumi@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroomi Tatsumi

Organization

Sapporo Meedical University School of Medicine

Division name

Department of Intensive Care Medicine

Zip code


Address

South 1 West 16, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Homepage URL


Email

htatsumi@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Meedical University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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 12 Month 08 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Main results already published

Date of protocol fixation

2018 Year 09 Month 30 Day

Date of IRB


Anticipated trial start date

2018 Year 09 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Of the 65 subjects, 9 (14%) withdrew from the CRRT during the course, 39 (60%) continued until the time of death. In 17 patients (26%) who completed early before the death, after discussing in multiple occupations about the disease condition in all cases sufficiently explained to the family, with the consent, the CRRT was terminated. 16 of them ended when the circuit pressure was increased, and one patient was terminated with the hope of terminating the CRRT from the family. The time from early termination to death was 201 minutes (median), 10 cases died within 4 hours after the end.


Management information

Registered date

2018 Year 12 Month 08 Day

Last modified on

2018 Year 12 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040099


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name