UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dynamic preload indices as a predictor of cardiac output decrease after anesthetic induction
Title of the study (Brief title)	Dynamic preload indices as a predictor of cardiac output decrease after anesthetic induction
Region	Japan

Condition
Condition	Patients undergoing laparoscopic surgery under genera anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the ability of dynamic preload indices to predict cardiac output decrease after anesthetic induction
Basic objectives2	Others
Basic objectives -Others	To assess the ability of dynamic preload indices to predict hypotension after anesthetic induction
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of cardiac output decrease after anesthetic induction
Key secondary outcomes	The incidence of hypotension after anesthetic induction

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing laparoscopic surgery under general anesthesia
Key exclusion criteria	1) Atrial fibrillation 2) Decreased cardiac function (Ejection Fraction <50%) 3) Decreased renal function (Serum Cre >2.0mg/dl) 4) Hypernatremia (Serum Na >155mEq/L) or hyperchloremia (Serum Cl>120mEq/L) 5) Intracranial hemorrhage
Target sample size	45

Research contact person
Name of lead principal investigator	Koichi Suehiro
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Anesthesiology
Address	1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL	06-6645-2186
Email	suehirokoichi@yahoo.co.jp

Public contact
Name of contact person	Koichi Suehiro
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Anesthesiology
Address	1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL	06-6645-2186
Homepage URL
Email	suehirokoichi@yahoo.co.jp

Sponsor
Institute	Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Osaka City University Graduate School of Medicine
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	2015 Year 11 Month 04 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 09 Month 29 Day
Anticipated trial start date	2015 Year 11 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	All subjects are divided into "Decreased CO group" or "Non-decreased CO group" according to cardiac output decrease after anesthetic induction. Receiver operating characteristic curves of dynamic preload indices are constructed to predict cardiac output decrease after anesthetic induction.

Management information
Registered date	2015 Year 11 Month 04 Day
Last modified on	2016 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022696