臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 15, 2024
Last modified on	Feb. 17, 2025
Trial ID	jRCTs031230568

Scientific Title	The Vasopressin Loading for Refractory septic shock (VALOR) study: a single-center randomized controlled trial. (VAROLstudy)
Public Title	The Vasopressin Loading for Refractory septic shock (VALOR) study (VAROLstudy)

Completion date	Dec. 17, 2024
Result actual enrolment	0
Baseline Characteristics	Patient with septic shock
Participant flow	None
Adverse events	None
Outcome measures	None
Brief summary	Terminated without patient enrollment
Date of posting of results summaries	Feb. 17, 2025
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	Contents of the consent document and explanatory document (attached)
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs031230568

Contact for Scientific Queries	Name	Nakamura Kensuke
	Affiliation	Yokohama City University Hospital
	Address	3-9 Fukuura Kanazawa-ku Yokohama-city Kanagawa, Japan
	Telephone	+81-45-787-2800
	E-mail	nakamura.ken.kl@yokohama-cu.ac.jp
Contact for Public Queries	Name	Suganuma Shinya
	Affiliation	Yokohama City University Hospital
	Address	3-9 Fukuura Kanazawa-ku Yokohama-city Kanagawa, Japan
	Telephone	+81-45-787-2800
	E-mail	suganuma.shi.en@yokohama-cu.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Jan. 15, 2024
Actual date of first enrollment
Target sample size		250
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Age at enrollment is 20 years or older (2) Patients diagnosed with septic shock based on Sepsis-3 (requiring noradrenaline or other hypertensive drugs to maintain an average blood pressure of 65 mmHg or higher despite adequate infusion load, and blood lactate level of 2 mmol/L or higher) (3) Patients receiving noradrenaline 0.2 gamma or higher
	Exclusion Criteria	(1) Participated in this clinical study in the past (2) Patients who are otherwise judged by the physician to be inappropriate for inclusion in the study (3) Patients for whom the administration of this drug is contraindicated (4) Patients who cannot find a surrogate and whose state of consciousness is not expected to improve
	Age Minimum	20age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		septic shock
Intervention(s)		For patients receiving more than 0.2 gamma of noradrenaline, a 1U bolus dose of vasopressin is administered.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Lactate change before and 2 hours after administration
Secondary Outcome(s)		Duration of ICU stay, total hospital stay, catecholamine index at 2, 4, 6, and 24 hours, duration of ventilation, duration of hemodialysis, 24-hour IN/OUT/NET balance and urine output, blood gas findings before and after and at 24 hours, adverse events (limb/intestinal/myocardial ischemia, 30-day in-hospital deaths), steroid use

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Yokohama City University Certified Review Board
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
Telephone	+81-45-370-7627
E-Mail	ycu_crb@yokohama-cu.ac.jp
Approval Status	Approval
Date of approval	Jan. 11, 2024

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Feb. 17, 2025	(this page)	Changes
3	May. 14, 2024	Detail	Changes
2	May. 02, 2024	Detail	Changes
1	Jan. 15, 2024	Detail

List of change history