臨床研究等提出・公開システム

Date of registration	Dec. 29, 2022
Last modified on	July. 19, 2023
Trial ID	jRCT1012220033

Scientific Title	Efficacy of Acumen HPI system to reduce intraoperative hypotension
Public Title	Efficacy of Acumen HPI system

Contact for Scientific Queries	Name	Yoshikawa Yusuke
	Affiliation	Sapporo Medical University
	Address	South1 West17 Chuoku Sapporo
	Telephone	+81-11-688-9663
	E-mail	y.yoshikawa@sapmed.ac.jp
Contact for Public Queries	Name	Yoshikawa Yusuke
	Affiliation	Sapporo Medical University
	Address	South1 West17 Chuoku Sapporo
	Telephone	+81-11-688-9663
	E-mail	y.yoshikawa@sapmed.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 29, 2022
Actual date of first enrollment		Feb. 13, 2023
Target sample size		64
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	no treatment control/standard of care control
	assignment	factorial assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	equal to or older than 45 years old Patients who receive non-cardiac surgery under general anesthesia Patients who are scheduled to be managed with arterial line
	Exclusion Criteria	Emergent surgery Vascular surgery, hepatic sugery, neurosurgery Thoracic surgery, surgery with prone position, severe valvular disease, arrhythmia, intracardiac shunt, chronic hemodyalisis Other patients who are considered inappropriate for the study by the attending anesthesiologists
	Age Minimum	45age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Non-cardiac surgery
Intervention(s)		-Hemodynamic monitoring with arterial line- Goal directed therapy is performed with Acumen HPI system (Edwards Life Science, 30400BZX00002000) during surgery. -Administration of hemodynamic drugs based on a protocol- Fluid therapy with crystalloid and colloid fluid and hemodynamic drugs including ephedrine (5-10 mg) and phenylephrine (0.05-0.1 mg) are applied for goal directed therapy.
Primary Outcome(s)		Intraoperative time weighted average (TWA) (mean arterial pressure < 65 mmHg)
Secondary Outcome(s)		Incidence of hypotension, total number of hypotensive events, average duration of each hypotensibe event, total duration of hypotension, mean MAP under 65 mmHg, area under 65 mmHg for MAP, number of patients that experience an event under 50 mmHg, patients background, anesthetic and surgical factors, dose of hemodynamic drugs, volume of infusion and transfusion, hemodynamic parameters, BGA, admission days, 30-day mortality

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	The Institutional Review Board of Sapporo Medical University Hospital
Address	South 1, West 16, 291, Chuo-ku, Sapporo, Hokkaido, Hokkaido, Hokkaido
Telephone	+81-11-611-2111
E-Mail	ji-rskk@sapmed.ac.jp
Approval Status	Approval
Date of approval	Dec. 08, 2022

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	July. 19, 2023	(this page)	Changes
2	Feb. 16, 2023	Detail	Changes
1	Dec. 29, 2022	Detail

List of change history