UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013800 |
|---|---|
| Receipt number | R000015998 |
| Scientific Title | Optimization of perioperative fluid management |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2023/11/21 12:40:05 |
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Basic information
Public title
Optimization of perioperative fluid management
Acronym
Optimization of perioperative fluid management
Scientific Title
Optimization of perioperative fluid management
Scientific Title:Acronym
Optimization of perioperative fluid management
Region
| Japan |
Condition
Condition
myoma uteri, endometriosis, ovarian cyst, ovarian tumor
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verifying proper fluid management during perioperative period for avoiding rapid fluid load
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Avoiding rapid fluid loading in 6 hours of postoperative period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Injection of crystalloids 7mL/kg/hr during intraoperative period, and 100mL/hr during postoperative period
Interventions/Control_2
Injection of crystalloids 5mL/kg/hr during intraoperative period, and 150mL/hr during postoperative period
Interventions/Control_3
Injection of crystalloids 5mL/kg during intraoperative period, and 100mL/hr during postoperative period
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
Female
Key inclusion criteria
The patinets who plan laparoscopic surgery for gynecologic benign disease, twenty years old or older female, and American Society of Anesthesiologist classification 1 and 2.
Key exclusion criteria
Patients with diabetes mellitus or morbid obesity (BMI > 35)
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Tomofumi |
| Middle name | |
| Last name | Suzuki |
Organization
Keiaikai Nakagami General Hospital
Division name
Anesthesiology
Zip code
9042142
Address
610, Noborikawa, Okinawa city, Okinawa Pref.
TEL
098-939-1300
tomofumi-suzuki@anesth.name
Public contact
Name of contact person
| 1st name | Tomofumi |
| Middle name | |
| Last name | Suzuki |
Organization
Keiaikai Nakagami General Hospital
Division name
Anesthesiology
Zip code
9042142
Address
610, Noborikawa, Okinawa city, Okinawa Pref.
TEL
098-939-1300
Homepage URL
tomofumi-suzuki@anesth.name
Sponsor or person
Institute
Anesthesiology of Nakagami General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Nakagami Hospital and Chibana Clinic
Address
610, Noborikawa, Okinawa city, Okinawa Pref.
Tel
098-939-1300
soumu@nakagami.or.jp
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
中頭病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 24 | Day |
Last modified on
| 2023 | 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=R000015998
