UMIN-CTR Clinical Trial

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
Last 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
Email	kohji.fentanyl@gmail.com

Public contact
1st 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
Email	kohji.fentanyl@gmail.com

Sponsor
Institute	Kyorin University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025881