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ADRESS: Dexmedetomidine in Refractory Septic Shock
NCT07569536Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Sep 2026
- Primary completion
- Oct 2028
- Countries
- 1
- Sponsor
- Hospices Civils de Lyon
- Modality
- Small Molecules
- Drugs
- dexmedetomidine
- Conditions
- septic shock
01
Overview
Phase 3, randomised, open-label trial of dexmedetomidine in septic shock (2 arms), sponsored by Hospices Civils de Lyon. Primary endpoint: 30-day mortality. Planned start Sep 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Dexmedetomidine 100 µg/Ml
Continuous infusion of dexmedetomidine at 0.7 µg/kg/h for 2 hours, then 1 µg/kg/h for up to 14 days.
Standard care
Optimized, protocolized management in strict adherence to current guidelines.
03
Who it enrols
Adults with refractory septic shock requiring high-dose norepinephrine and invasive mechanical ventilation, excluding those with severe bradycardia, low cardiac index, or severe hepatic insufficiency.
04
Endpoints
Primary
30-day mortality
Secondary
72-hour mortality
Vasopressor exposure
Use of vasopressin or rescue therapies
Mean arterial pressure
Vasopressor-free days
Mechanical ventilation-free days
Blood lactate concentration
Sequential Organ Failure Assessment score
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