UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025375
Receipt number R000029205
Scientific Title Effects of intraoperative pleth variability index-based goal-directed fluid management on perioperative management in patients undergoing pancreaticoduodenectomy
Date of disclosure of the study information 2017/01/04
Last modified on 2016/12/22 17:53:49

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Basic information

Public title

Effects of intraoperative pleth variability index-based goal-directed fluid management on perioperative management in patients undergoing pancreaticoduodenectomy

Acronym

Pleth variability index-directed fluid management

Scientific Title

Effects of intraoperative pleth variability index-based goal-directed fluid management on perioperative management in patients undergoing pancreaticoduodenectomy

Scientific Title:Acronym

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

1st name
Middle name
Last name Chiaki Murakami

Organization

Tokushima Prefectural Central Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-10-3 Kuramoto, Tokushima 770-8539, Japan

TEL

088-633-7151

Email

chia.murakami@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Chiaki Murakami

Organization

Tokushima Prefectural Central Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-10-3 Kuramoto, Tokushima 770-8539, Japan

TEL

088-633-7151

Homepage URL


Email

chia.murakami@gmail.com


Sponsor or person

Institute

Department of Anesthesiology, Tokushima Prefectural Central 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


Address


Tel


Email



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


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

Preinitiation

Date of protocol fixation

2016 Year 12 Month 10 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029205


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name