UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025393
Receipt number R000029195
Scientific Title The effect of fluid therapy on kidney function in hyperglycemIc emergencies. A multicenter retrospective study
Date of disclosure of the study information 2016/12/23
Last modified on 2023/06/29 08:44:40

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Basic information

Public title

The effect of fluid therapy on kidney function in hyperglycemIc emergencies. A multicenter retrospective study

Acronym

The effeCt of fLuid therapy On kidney function in hypeRglycemIc emergeNciEs. A multicenter retrospective STUDY (CLORINE STUDY)

Scientific Title

The effect of fluid therapy on kidney function in hyperglycemIc emergencies. A multicenter retrospective study

Scientific Title:Acronym

The effeCt of fLuid therapy On kidney function in hypeRglycemIc emergeNciEs. A multicenter retrospective STUDY (CLORINE STUDY)

Region

Japan


Condition

Condition

Hyperglycemic emergencies
Diabetic ketoacidosis
Hyperglycemic hyperosmolar syndrome

Classification by specialty

Medicine in general Endocrinology and Metabolism Nephrology
Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effect of fluid therapy on kidney function in hyperglycemic emergencies

Basic objectives2

Others

Basic objectives -Others

To investigate the epidemiology, clinical characteristics, and prognosis of hyperglycemic emergencies in Japan.
To evaluate the diagnostic yield of physiological and biochemical parameters for infection in patients with hyperglycemic emergencies.

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Effect of the total amount of chloride in fluid administered within 48 hours of admission on the recovery of renal function in patients presenting with hyperglycemic emergencies complicated with AKI on admission.

Key secondary outcomes

Effect of the total amount of chloride in fluid on the incidence of AKI in patients without AKI on admission.
The incidence, clinical characteristics (i.e, background type of diabetes, comorbidities, complications, provocating factors, complications, need for medical resources), and prognosis of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome.
Comparison of diagnostic yields of vital signs, white blood cell counts, C-reactive protein, and arterial blood gas analysis for the detection of infection in patients with hyperglycemic emergencies.


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome on admission

Key exclusion criteria

None

Target sample size

700


Research contact person

Name of lead principal investigator

1st name Norimichi
Middle name
Last name Uenishi

Organization

Fujita Health University Hospital

Division name

Department of emergency and general internal medicine

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN

TEL

0562-93-2111

Email

uenishimd@yahoo.co.jp


Public contact

Name of contact person

1st name Norimichi
Middle name
Last name Uenishi

Organization

Fujita Health University Hospital

Division name

Department of emergency and general internal medicine

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN

TEL

0562-93-2111

Homepage URL


Email

uenishimd@yahoo.co.jp


Sponsor or person

Institute

Fujita Health University Hospital

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Japanese Society of Education for Physicians and Trainees in Intensive Care Clinical Trial Group (JSEPTIC-CTG)

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Fujita Health University Hospital

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN

Tel

0562-93-2865

Email

f-irb@fujita-hu.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

藤田医科大学病院 (愛知県)
自治医科大学附属さいたま医療センター(埼玉県)
倉敷中央病院 (岡山県)
京都府立医科大学病院 (京都府)
諏訪中央病院 (長野県)
練馬光が丘病院(東京都)
淀川キリスト教病院(大阪府)
洛和会丸太町病院(京都府)
北海道大学病院(北海道)
国立病院機構 東近江総合医療センター(滋賀県)
熊本赤十字病院(熊本県)
名古屋医療センター(愛知県)
湘南鎌倉総合病院(神奈川県)
鳥取県立中央病院(鳥取県)
横浜市立みなと赤十字病院(神奈川県)
群馬大学医学部附属病院(群馬県)
武蔵野赤十字病院(東京都)
順天堂大学医学部附属練馬病院(東京都)
沖縄県立中部病院(沖縄県)
亀田総合病院(千葉県)
公立豊岡病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 23 Day


Related information

URL releasing protocol

https://www.jsicm.org/pdf/kenkyukikakusho16.pdf

Publication of results

Unpublished


Result

URL related to results and publications

N/A

Number of participants that the trial has enrolled

767

Results

pending

Results date posted

2023 Year 01 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients hospitalized for diabetic emergency

Participant flow

N/A

Adverse events

N/A

Outcome measures

N/A

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2016 Year 12 Month 12 Day

Date of IRB

2016 Year 11 Month 24 Day

Anticipated trial start date

2017 Year 01 Month 10 Day

Last follow-up date

2021 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2024 Year 12 Month 31 Day


Other

Other related information

None


Management information

Registered date

2016 Year 12 Month 23 Day

Last modified on

2023 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029195


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name