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The Vasopressin Loading for Refractory septic shock (VALOR) study

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031230568
Enrollment
250
Registered
2024-01-15
Start date
2024-01-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

septic shock

Interventions

For patients receiving more than 0.2 gamma of noradrenaline, a 1U bolus dose of vasopressin is administered.

Sponsors

Nakamura Kensuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Lactate change before and 2 hours after administration

Secondary

MeasureTime frame
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

Contacts

Public ContactShinya Suganuma

Yokohama City University Hospital

suganuma.shi.en@yokohama-cu.ac.jp+81-45-787-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026