UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018243 |
|---|---|
| Receipt number | R000019477 |
| Scientific Title | Prospective study of perioperative Goal Directed Therapy for free-flap surgery |
| Date of disclosure of the study information | 2015/07/08 |
| Last modified on | 2019/01/11 17:15:13 |
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Basic information
Public title
Prospective study of perioperative Goal Directed Therapy for free-flap surgery
Acronym
Prospective study of GDT for free-flap surgery
Scientific Title
Prospective study of perioperative Goal Directed Therapy for free-flap surgery
Scientific Title:Acronym
Prospective study of GDT for free-flap surgery
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Oto-rhino-laryngology | Anesthesiology | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate prospectively whether infusion and vasopressors management by GDT protocol during and after surgery can reduce the length of hospital stay and the number of postoperative complications as compared to the management that do not use the protocol
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complications during 28 days after surgery
Key secondary outcomes
Length of hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Device,equipment |
Interventions/Control_1
General monitor, arterial line (frotrac sensor and vigileo monitor) and CV line are used
Fluid administration and vasoactive agents using GDT protocol
Interventions/Control_2
General monitor, arterial line and CV line are used
Liberal fluid administration and vasoactive agents upon an anesthesiologist judgement
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) ASA 1or2
2) Written informed concent must be obtaind from patients
Key exclusion criteria
1) ASA >3
2) Emergency surgery
3) Patients enrollment to the study is determinated to be inappropriate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Kondo |
Organization
Jikei University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
3-25-8Nishishinbashi Minatoa-ku Tokyo
TEL
0334331111
ichirok@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Kondo |
Organization
Jikei University Hospital
Division name
Department of Anesthesiology
Zip code
Address
3-19-18 Nishishinbashi Minatoa-ku Tokyo
TEL
0334331111
Homepage URL
ichirok@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Edwards Life Science
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 07 | Month | 08 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 08 | Day |
Last modified on
| 2019 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019477
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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