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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015522
Receipt No. R000018031
Scientific Title Effect of glycemic control using glucose-insulin infusion on postoperative inflammatory responses, renal function, complications, and outcomes in major oral and maxiilfacial surgery
Date of disclosure of the study information 2014/10/25
Last modified on 2016/04/25

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Basic information
Public title Effect of glycemic control using glucose-insulin infusion on postoperative inflammatory responses, renal function, complications, and outcomes in major oral and maxiilfacial surgery
Acronym Effect of glycemic control during oral and maxillofacial surgery on postoperative inflammatory responses and outcome
Scientific Title Effect of glycemic control using glucose-insulin infusion on postoperative inflammatory responses, renal function, complications, and outcomes in major oral and maxiilfacial surgery
Scientific Title:Acronym Effect of glycemic control during oral and maxillofacial surgery on postoperative inflammatory responses and outcome
Region
Japan

Condition
Condition Patients who are schduled for radical operation of oral malignant tumors along with tissue reconstruction
Classification by specialty
Dental medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the effect of intraoperative glycemic control by glucose-insulin infusion on postoperative inflammatory responses, renal function, postoperative systemic complications and outcomes in patients undergoing major oral and maxillofacial surgeries, which requires tissue reconstruction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes It is supposed that postoperative inflammatory responses, postoperative complications, and days required until discharge may be reduced by intraoperative glucose-insulin infusion.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Regular insulin was continuously applied along with infusion of glucose-containing acetate Ringer's solution (10g glucose per 500mL) during surgery, and blood glucose wa adjusted within the target concentration of 80 - 120 mg/dL.
Interventions/Control_2 Acetate Ringer's solution, which contains 1% (W/V) glucose or lactate Ringer's solution, which does not contain glucose, was infused, and regular insulin is applied each time when a blood glucose concentration is 180mg/dL or more.
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with ASA physical status 1-2 and those who are scheduled for radical operations of oral malignant tumors with tissue reconstruction.
Key exclusion criteria Patients whose operation time is less than 8H or those who were not able to continue insulin infusion due to hypoglycemia.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Kohjitani
Organization Kagoshima University Medical and Dental Hospital
Division name Dental Anesthesiology
Zip code
Address 8-35-1 Kagoshima
TEL 099-275-6287
Email atsushik@dent.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Kohjitani
Organization Kagoshima University Medical and Dental Hospital
Division name Dental Anesthesiology
Zip code
Address 8-35-1 Kagoshima
TEL 099-275-6287
Homepage URL
Email atsushik@dent.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Medical and Dental Hospintal
Institute
Department

Funding Source
Organization Kagoshima University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 10 Month 25 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 24 Day
Last modified on
2016 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018031

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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