UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of intraoperative pleth variability index-based goal-directed fluid management on perioperative management in patients undergoing pancreaticoduodenectomy
Title of the study (Brief title)	Pleth variability index-directed fluid management
Region	Japan

Condition
Condition	Patients scheduled for elective pancreaticoduodenectomy
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We measure the impact of pleth variability index (PVI)-based goal-directed fluid management on perioperative management.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Volume of intraoperative fluids
Key secondary outcomes	Length of hospital stay

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	In the PVI group, intraoperative fluid infusion is managed based on PVI as determined by the pulse oximeter plethysmogram.
Interventions/Control_2	In the control group, intraoperative fluid infusion was managed based on hemodynamics and urinary output.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients scheduled for elective pancreaticoduodenectomy
Key exclusion criteria	Patients with cardiac arrhythmias, cardiopulmonary dysfunction, or kidney dialysis
Target sample size	15

Research contact person
Name of lead principal investigator	Chiaki Murakami
Organization	Tokushima Prefectural Central Hospital
Division name	Department of Anesthesiology
Address	1-10-3 Kuramoto, Tokushima 770-8539, Japan
TEL	088-633-7151
Email	chia.murakami@gmail.com

Public contact
Name of contact person	Chiaki Murakami
Organization	Tokushima Prefectural Central Hospital
Division name	Department of Anesthesiology
Address	1-10-3 Kuramoto, Tokushima 770-8539, Japan
TEL	088-633-7151
Homepage URL
Email	chia.murakami@gmail.com

Sponsor
Institute	Department of Anesthesiology, Tokushima Prefectural Central Hospital
Institute
Department

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)

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	2017 Year 01 Month 04 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 10 Day
Anticipated trial start date	2017 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 22 Day
Last modified on	2016 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029205