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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025393
Receipt No. 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 2019/06/26

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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
Institute Fujita Health University Hospital
Institute
Department

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 767
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 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

Other
Other related information None

Management information
Registered date
2016 Year 12 Month 23 Day
Last modified on
2019 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.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


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