UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Blood sugar variation indexes are useful for predicting the severity of sepsis: a prospective observational study
Title of the study (Brief title)	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	Moritoki Egi
Organization	Kobe University Hospital
Division name	Department of Anesthesiology
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
TEL	078-382-6172
Email	moriori@tg8.so-net.ne.jp

Public contact
Name of contact person	Moritoki Egi
Organization	Kobe university graduate school of medicine
Division name	Division of anesthesiology, Department of suegery related,
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
TEL	078-382-6172
Homepage URL
Email	moriori@tg8.so-net.ne.jp

Sponsor
Institute	Kobe university graduate school of medicine
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031694