UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022459 |
|---|---|
| Receipt number | R000025881 |
| Scientific Title | Optimum fluid therapy to minimize the postoperative complications of long surgery : randomized controlled trial |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2019/03/29 09:00:30 |
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Basic information
Public title
Optimum fluid therapy to minimize the postoperative complications of long surgery : randomized controlled trial
Acronym
Study of optimal fluid therapy and lung protection ventilation to minimize the postoperative complications of long surgery
Scientific Title
Optimum fluid therapy to minimize the postoperative complications of long surgery : randomized controlled trial
Scientific Title:Acronym
Study of optimal fluid therapy and lung protection ventilation to minimize the postoperative complications of long surgery
Region
| Japan |
Condition
Condition
Gastrointestinal Surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the optimal combination of ifluid therapy and optimal respiration method of managing long abdominal surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative hospital stay
Key secondary outcomes
Postoperative complications of up to either early the day of up to hospital discharge after surgery or 28 days
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Restrictive transfusion management /
1) with respect to blood pressure lowering at the time of induction of anesthesia, the administration of phenylephrine.
2) intraoperative maintenance infusion dose and 3ml / kg / h.
3) If the stroke volume change of arterial pressure cardiac output sensor (flow tracks) (SVV) becomes 15 or more, VOL (: 6% HES130 / 0.4 / 9) rapidly administering the (5ml / kg) and, if .SVV that SVV is to stop administered in 13 or less is 13 or more, again, rapid administration (5ml / kg) of the VOL.
4) If the amount of urine is less than or equal to 0.5ml / kg / h, to VOL bolus administration (5ml / kg).
5) the time of bleeding, if the Hb is 7 or less, to start the transfusion of packed red blood cells, as long as 7 or more, the amount of bleeding and an equal amount administering the VOL.
6) blood pressure is lowered, if you do not want to recover the baseline value in the above infusion management will review the administration of the vasoconstrictor, if SVI is less than or equal to 35, to consider the DOB administration.
Interventions/Control_2
Non-limiting infusion management /
1) For low blood pressure during anesthesia induction, when administering a crystalloid solution. Responsible anesthesiologist physician determines that it is necessary to vasopressors, administering an appropriate vasopressor.
2) Maintenance infusion is administered at 6ml / kg / h.
3) hemodynamic after crystalloid fluid administration to measure the baseline vital signs in a stable point in time, blood pressure, HR together so as to maintain the baseline value 20%, managed by the amorphous liquid dosage and vasoconstrictor to.
4) If the amount of urine is less than or equal to 1ml / kg / h, the rapid administration of the VOL (5ml / kg).
5) With respect to anesthesia management other than those described above and the judgment of the attending anesthesiologist.
Interventions/Control_3
Lung protection management /
1) pressure-limited ventilation with PEEP (the positive end-expiratory pressure) is set to 5 ~ 10cmH2O, tidal
The amount shall be 5 ~ 7ml / kg.
2) PaO2 / FIO2 (P / F ratio: the arterial pressure oxidation oxygen partial pressure / inhalation phase oxygen partial pressure) lung pressure is when it becomes 80% or less of the case or the expected P / F ratio falls below 400 make up to 1 times / h. Lung pressurizing method is, I: E: the (inspiratory time expiratory time) 0.8 seconds: using a three-breathing 0.5 seconds. (High peep: 45 / low peep: 10)
3) extubation, the pressurized pressure relief tube, when it is not necessary, the endotracheal suction is not performed.
Interventions/Control_4
A non-lung-protective ventilator management / 1) PEEP 5cmH2O, tidal volume and 8 ~ 10ml / kg.
2) pulmonary pressure is not performed.
3) at the time of extubation to pressure the pressure relief tube from the suction in the trachea.
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)Undergo elective abdominal surgery of more than 3 hours elective surgery time in our hospital, the patient's plan to use the intraoperative arterial pressure catheter
2)Adult patients test responsible can understand the description of the doctor, can be their own signature
3)The weight of the patient 35Kg during surgery
Key exclusion criteria
1) Patient ASA-PS is 3 or more
2) Patients can not be controlled by drug therapy cardiogenic of arrhythmia is as comorbidities
3) Pregnant patient
4) Patients with unresectable malignant tumors in addition to the surgical site
5) Patients other attending physician and responsible anesthesiology physician, it is determined that it should not participate in the study
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Kohji |
| Middle name | |
| Last name | Uzawa |
Organization
Kyorin University Hospital
Division name
Department of Anesthesiology
Zip code
181-0004
Address
6-20-2 Shinkawa Mitaka City Tokyo Japan
TEL
0422-47-5511
kohji.fentanyl@gmail.com
Public contact
Name of contact person
| 1st name | Kohji |
| Middle name | |
| Last name | Uzawa |
Organization
Kyorin University Hospital
Division name
Department of Anesthesiology
Zip code
181-0004
Address
6-20-2 Shinkawa Mitaka City Tokyo Japan
TEL
0422-47-5511
Homepage URL
kohji.fentanyl@gmail.com
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
kyorin university
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University School of Medicine Ethics Committee
Address
6-20-2 Shinkawa Mitaka-shi Tokyo Japan
Tel
0422-47-5511
irb@ks.kyorin-u.ac.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
杏林大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 25 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025881
