臨床研究等提出・公開システム

Date of registration	April. 01, 2026
Last modified on	April. 01, 2026
Trial ID	jRCT1041260001

Scientific Title	Evaluation of the Protective Effect of Intraoperative Amino Acid Infusion on Acute Kidney Injury During Cardiovascular Surgery With Cardiopulmonary Bypass
Public Title	A study to see whether giving amino acids during heart surgery can help protect the kidneys

Contact for Scientific Queries	Name	Nakajima yoshiki
	Affiliation	Department of Anesthesiology and Intensive Care
	Address	1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka, Japan
	Telephone	+81-53-435-2111
	E-mail	nakayos@hama-med.ac.jp
Contact for Public Queries	Name	Asai Kenta
	Affiliation	Department of Medical Equipment Management
	Address	1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka, Japan
	Telephone	+81-53-435-2985
	E-mail	asaken64@hama-med.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 01, 2023
Target sample size		300
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who underwent cardiovascular surgery with cardiopulmonary bypass at Hamamatsu University School of Medicine Hospital between January 1, 2023 and August 31, 2025
	Exclusion Criteria	1.Patients in whom hemodialysis has been initiated preoperatively or is planned postoperatively 2.Patients with chronic kidney disease stage IV or higher 3.Cases in which the patient or the patient's legal representative refuses or withdraws participation in this study 4.Cases found after enrollment not to meet the eligibility criteria 5.Patients with an allergy to amino acid preparations
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Acute Kidney Injury
Primary Outcome(s)		Presence or absence of acute kidney injury (AKI), assessed using the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Secondary Outcome(s)		Severity of AKI,Duration of AKI,Duration of renal impairment (serum creatinine > 168 mmol/L),Time course of estimated glomerular filtration rate (eGFR),Urine output,Use of renal replacement therapy (RRT),Duration of RRT,Transition to maintenance hemodialysis,Serum urea level,Fluid balance (input-output balance),Duration of oliguria,Use of diuretics,Length of stay in the intensive care unit (ICU),Use of vasopressors,Duration of mechanical ventilation,Reoperation,Change in antibiotics,Atrial fibrillation,Ventricular fibrillation,Ventricular tachycardia,Cardiopulmonary resuscitation (CPR),Stroke,Mortality

Primary Sponsor	none

Secondary Sponsor

Name of Certified Review Board	approved by the National University Corporation Hamamatsu University School of Medicine Clinical Research Review Board
Address	1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka, Japan, Shizuoka
Telephone	+81-53-435-2680
E-Mail	kenkyou.s@hama-med.ac.jp
Approval Status	Approval
Date of approval	Nov. 04, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none