The Vasopressin Loading for Refractory septic shock (VALOR) study

JRCT ID: jRCTs031230568

Registered date:15/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: septic shock
• Date of first enrollment: 15/01/2024
• Target sample size: 250
• Study type: Interventional
• Intervention(s): For patients receiving more than 0.2 gamma of noradrenaline, a 1U bolus dose of vasopressin is administered.

Outcome(s)

• Primary Outcome: Lactate change before and 2 hours after administration
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Nakamura Kensuke