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ADRESS : Efficacy of the Alpha 2 agonist dexmedetomidine for sympathetic Deactivation in REfractory Septic Shock: a randomized, controlled trial
EU CTIS ID: 2025-524122-18-00
What this study is testing
Evaluate the impact of dexmedetomidine (DEX) as an adjunctive treatment for refractory septic shock on 30-day mortality in mechanically ventilated patients compared to standard care.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years.
- Septic shock, defined according to the ‘Sepsis-3’ criteria: Proven or suspected infection, with a SOFA score increase of ≥2 points ; Persistent hypotension requiring vasopressors to maintain a MAP >65 mmHg ; And a serum lactate level >2 mmol/L despite adequate fluid resuscitation.
- Catecholamine resistance, defined as: The need for an equivalent dose of norepinephrine tartrate ≥0.5 µg/kg/min (according to the NEE vasopressor score, accounting for any concomitant administration of vasopressin, for example) for more than 2 consecutive hours AND Persistent circulatory failure with at least one of the following criteria present within the 2 hours preceding randomization: Hyperlactatemia >2 mmol/L And/or mottling (score ≥1) And/or oliguria (urine output <0.5 ml/kg/h over the last 2 hours).
- Adequate fluid resuscitation: ≥30 ml/kg OR absence of preload dependence criteria (e.g., passive leg raise, pulse pressure variation).
- Patient under invasive mechanical ventilation.
- Patient affiliated with a social security scheme or equivalent.
You likely can't join if
- Cardiac index <2.2 L/min/m² after volume correction
- Patient for whom a decision to limit or withdraw life-sustaining treatments has been made
- Patient under legal protection (guardianship or curatorship) or judicial safeguard
- Contraindications to any of the adjunct medications — norepinephrine, midazolam, propofol, and hydrocortisone — according to their respective SmPCs.
- Patient participating in another study with an ongoing exclusion period at inclusion
- Pregnant woman (β-HCG ≥5 IU/L) or breastfeeding
See the full eligibility criteria
Who can join
- Age ≥ 18 years.
- Septic shock, defined according to the ‘Sepsis-3’ criteria: Proven or suspected infection, with a SOFA score increase of ≥2 points ; Persistent hypotension requiring vasopressors to maintain a MAP >65 mmHg ; And a serum lactate level >2 mmol/L despite adequate fluid resuscitation.
- Catecholamine resistance, defined as: The need for an equivalent dose of norepinephrine tartrate ≥0.5 µg/kg/min (according to the NEE vasopressor score, accounting for any concomitant administration of vasopressin, for example) for more than 2 consecutive hours AND Persistent circulatory failure with at least one of the following criteria present within the 2 hours preceding randomization: Hyperlactatemia >2 mmol/L And/or mottling (score ≥1) And/or oliguria (urine output <0.5 ml/kg/h over the last 2 hours).
- Adequate fluid resuscitation: ≥30 ml/kg OR absence of preload dependence criteria (e.g., passive leg raise, pulse pressure variation).
- Patient under invasive mechanical ventilation.
- Patient affiliated with a social security scheme or equivalent.
- Written consent obtained from the patient (or from the trusted person, family member, or relative if the patient is unable to sign/express consent), or emergency inclusion if the patient is unable to provide consent and neither the trusted person nor any family member or relative is present at the time of inclusion. In the context of refractory shock, the proposed therapeutic intervention cannot be delayed by more than one hour.
- Continuation consent obtained from the patient as soon as they are able to provide consent (in cases where consent was initially signed by the trusted person, a family member, or a relative at inclusion) and, in the case of emergency inclusion: continuation consent from the relative obtained as soon as possible (if the trusted person, a family member, or a relative arrives at the hospital while the patient is still unable to consent).
What rules you out
- Cardiac index <2.2 L/min/m² after volume correction
- Patient for whom a decision to limit or withdraw life-sustaining treatments has been made
- Patient under legal protection (guardianship or curatorship) or judicial safeguard
- Contraindications to any of the adjunct medications — norepinephrine, midazolam, propofol, and hydrocortisone — according to their respective SmPCs.
- Patient participating in another study with an ongoing exclusion period at inclusion
- Pregnant woman (β-HCG ≥5 IU/L) or breastfeeding
- Bradycardia <55 bpm (excluding treatment with β-blockers) or second- or third-degree AV block without pacing
- Moribund patient or those for whom death appears imminent within 24 hours (according to investigator judgment)
- Acute hepatocellular failure with PT and Factor V <50% in the absence of DIC (disseminated intravascular coagulation)
- Contraindications to dexmedetomidine: Known hypersensitivity to dexmedetomidine or to any of its excipients, advanced heart block (grade 2 or 3) unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular conditions.
- Patient receiving dexmedetomidine prior to randomization
- Patient treated with iproniazid within 15 days prior to randomization
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.