UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027680 |
|---|---|
| Receipt number | R000031694 |
| Scientific Title | Blood sugar variation indexes are useful for predicting the severity of sepsis: a prospective observational study |
| Date of disclosure of the study information | 2017/06/07 |
| Last modified on | 2017/11/21 07:09:12 |
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Basic information
Public title
Blood sugar variation indexes are useful for predicting the severity of sepsis: a prospective observational study
Acronym
Blood sugar variation index in sepsis patients
Scientific Title
Blood sugar variation indexes are useful for predicting the severity of sepsis: a prospective observational study
Scientific Title:Acronym
Blood sugar variation index in sepsis patients
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To objective of this study is to measure the HbA1c value at entry into the ICU and continuous blood glucose at 48 hours after the start of sepsis treatment and calculate the acute phase glycemic change index from both. We will examine the relationships of known prognostic indices of blood glucose control (mean blood sugar, peak blood sugar, minimum blood sugar, and blood glucose) with acute phase glycemic change index and patient prognosis, immune function during treatment of sepsis, oxidative stress response. We would like to clarify the most important index of glycemic control in sepsis patients.
Basic objectives2
Others
Basic objectives -Others
We will investigate the mechanism of acute blood glucose change by examining the relationships of known glycemic control indices (mean blood sugar, peak blood glucose, minimum blood sugar, and blood glucose variation) with acute blood glucose change index and blood glucose-regulating hormones.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total 28-day mortality
Key secondary outcomes
(1) Number of ICU-free days at the 28th day after ICU admission
(2) Number of ventilator-free days at 28th day after ICU admittion
(3) Incidence of organ disorder
(4) SOFA score
(5) immune function (48 hours after ICU admission, change ratio)
(6) oxidative stress (48 hours after ICU admission, change ratio)
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
(1) Patients with sepsis admitted to our hospital ICU (standard of sepsis being Sepsis - 3) who have suspected infection and an increase in SOFA score by 2 points or more
(2) Age of more than 20 years at the time of consent acquisition
(3) Patients expected to enter the ICU for more than 48 hours
(4) Documented consent obtained from the patient or substitute person for this research
Key exclusion criteria
(1) Patients under 20 years of age
(2) Pregnant patients
(3) Research director judged as inappropriate
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Moritoki Egi |
Organization
Kobe University Hospital
Division name
Department of Anesthesiology
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
TEL
078-382-6172
moriori@tg8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Moritoki Egi |
Organization
Kobe university graduate school of medicine
Division name
Division of anesthesiology, Department of suegery related,
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
TEL
078-382-6172
Homepage URL
moriori@tg8.so-net.ne.jp
Sponsor or person
Institute
Kobe university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 06 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: prospective observational study
Method:
We will measure HbA1c at the time of admission to the ICU and continuously measure blood glucose level for 48 hours after the start of sepsis treatment.
Next, we will calculate the blood glucose control index (changes in blood glucose level, maximum blood glucose level, lowest blood sugar level, blood sugar level) from continuous blood sugar measurement for 48 hours. We will also calculate an acute phase glycemic variation index using the value of HbA1c and the mean blood glucose value over a period of 48 hours in the ICU is calculated.
We will also obtain prognostic information (total 28-day mortality rate, number of ICU-free survival days at the 28th day after ICU admission, number of ventilator-free days at the 28th day after ICU admission, organ failure rate, SOFA score, immune function (48 hours and after change), and oxidative stress value (48 hours and after change)).
Statistical analysis:
We will analyze the relationships between HbA1c value at ICU admission, change in blood glucose level at 48 hours after the start of sepsis treatment, acute phase glycemic change index, patient prognosis, immune function, oxidative stress and blood glucose-regulating hormones.
From these results, we will assess optimal blood glucose control methods for improvement of immune function, reduction of oxidative stress, and improvement of prognosis.
Study period:
From the time of approval by the Ethics Committee until March 2020.
Management information
Registered date
| 2017 | Year | 06 | Month | 07 | Day |
Last modified on
| 2017 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031694
