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
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
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
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
