2025-524122-18-00招募中3 期
ADRESS : Efficacy of the Alpha 2 agonist dexmedetomidine for sympathetic Deactivation in REfractory Septic Shock: a randomized, controlled trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 18
- 主要终点
- Vital status at 30 days after randomization (Day 30).
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Dexmédétomidine/soin courant
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
DEXMÉDÉTOMIDINE VIATRIS 100 microgrammes/mL, solution à diluer pour perfusion
Test
干预措施: DEXMÉDÉTOMIDINE VIATRIS 100 microgrammes/mL, solution à diluer pour perfusion (Drug)
结局指标
主要结局
Vital status at 30 days after randomization (Day 30).
Vital status at 30 days after randomization (Day 30).
次要结局
- Efficacy Criteria: SOFA score at Day 0 and Day 3 after randomization.
- Efficacy criteria: Vital status at 72 hours after randomization.
- Efficacy criteria: Cumulative dose and peak of vasopressors in norepinephrine equivalent (NEE score, Kotani et al. 2023) at 6h, 12h, and 24h after randomization.
- Efficacy criteria: Rate of use of vasopressin (VP) or other rescue therapies during the 30 days following randomization (Day 0 → Day 30).
- Efficacy criteria: Evolution of mean arterial pressure (MAP) and MAP/Neq ratio (Neq = norepinephrine equivalent) within the first 24 hours after randomization (H0, H+6, H+12, H+24).
- Efficacy criteria: Number of vasopressor-free days during the 30 days following randomization (Day 0 → Day 30).
- Efficacy criteria: Number of mechanical ventilation–free days during the 30 days following randomization (Day 0 → Day 30).
- Efficacy Criteria: Lactate level at randomization, then at H+6, H+12, and H+24.
- Efficacy Criteria: Difference between total fluid intake (including IV infusions, enteral nutrition, blood products, flushes, and diluents) and total fluid losses (including urine output, drain outputs, and gastric tube losses) over 6 days (from Day 0 to Day 5).
- Efficacy Criteria: Occurrence of new-onset or persistent atrial fibrillation within 14 days following randomization.
- Efficacy Criteria: Vital status at ICU discharge and at 90 days after randomization.
- Tolerance Criteria: Occurrence of bradycardia during the treatment period: heart rate (HR) < 50 bpm requiring therapeutic intervention (discontinuation of dexmedetomidine due to bradycardia, administration of atropine, adrenaline, isoprenaline, or external electrical pacing).
- Tolerance Criteria: Number of coma-free days at Day 30 (or at ICU discharge if discharged before Day 30), defined as the number of days with a RASS score ≥ -3.
- Tolerance Criteria: Occurrence of ICU delirium during the stay, screened daily using the CAM-ICU score (Appendix 2) until Day 30 (or ICU discharge if discharged before Day 30) in patients with a RASS score (Appendix 2) ≥ -3.
- Ancillary Study Criteria: Serum electrolyte panel (Na⁺, K⁺, Cl⁻) at H0 (randomization), H+12, H+24, H+48, and Day 5; plasma measurements of endogenous catecholamines and plasma assays of the renin–angiotensin system (angiotensin I and II, aldosterone) at H0 (randomization), H+12, H+48, and Day 5. Urinary electrolyte panel (Na⁺, K⁺, Cl⁻) and urinary measurements of endogenous catecholamines and the renin–angiotensin system (angiotensin I and II, aldosterone) at H+24.
研究者
Dr Auguste DARGENT
Scientific
Hospices Civils De Lyon
研究点 (18)
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