UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the efficacy of central venous oxygen saturation (ScvO2) measured by PreSep/PediaSat and cardiac output measured by arterial pulse contour analysis (LiDCOrapid/FloTrac) as predictors of perioperative oxygen supply-demand balance. (An observational study)
Title of the study (Brief title)	A study of the efficacy of central venous oxygen saturation (ScvO2) and cardiac output measured by arterial pulse contour analysis as predictors of perioperative oxygen supply-demand balance. (An observational study)
Region	Japan

Condition
Condition	Surgical patients
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy of ScvO2 and cardiac output measured by arterial pulse contour analysis as predictors of perioperative oxygen supply-demand balance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Perioperative change of lactate/organ function. The parameters of organ function consist of the following: AST, ALT, bilirubin, BUN, creatinine, PaO2, P/F ratio, and duration of mechanical ventilation.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Surgical patients, who require monitoring of intra-arterial blood pressure and central venous pressure, undergoing general anesthesia
Key exclusion criteria	Contraindication for a central venous catheter placement
Target sample size	100

Research contact person
Name of lead principal investigator	Toru Imabayashi
Organization	Graduate School of Medical and Dental Sciences, Kagoshima University
Division name	Department of Anesthesiology and Critical Care Medicine
Address	8-35-1 Sakuragaoka, Kagoshima, Kagoshima
TEL	099-275-5430
Email	ii1111@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Toru Imabayashi
Organization	Kagoshima University Medical and Dental Hospital
Division name	Department of Anesthesiology
Address	8-35-1 Sakuragaoka, Kagoshima, Kagoshima
TEL	099-275-5430
Homepage URL
Email	ii1111@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Graduate School of Medical and Dental Sciences, Kagoshima University
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	2013 Year 03 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 03 Month 01 Day
Anticipated trial start date	2013 Year 03 Month 01 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	We measure the variation of ScvO2 measured by PreSep/PediaSat and cardiac output measured by arterial pulse contour analysis (LiDCOrapid/FloTrac). The correlation between the variations of ScvO2/cardiac output and lactate/organ function is examined. The parameters of organ function consist of the following: AST, ALT, bilirubin, BUN, creatinine, PaO2, P/F ratio, and duration of mechanical ventilation. This study is a prospective study.

Management information
Registered date	2013 Year 02 Month 05 Day
Last modified on	2017 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011663