UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015522 |
|---|---|
| Receipt number | 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 18:41:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
atsushik@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Medical and Dental Hospintal
Institute
Department
Personal name
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
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
Value
https://center6.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 |
