2023-510449-51-00招募中3 期
KISS Evaluation of early administration of Levetiracetam in the prevention and treatment of delirium during septic shock: a randomized, double-blind, placebo-controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 9
- 主要终点
- The primary endpoint of the KiSS study will be the number of days alive without delirium or coma at D14 following randomization.
研究概览
简要总结
To assess the impact of early 7-day administration of levetiracetam in patients with septic shock hospitalized in the ICU on the number of days alive without coma or delirium at D14.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •hospitalized in intensive care for less than 96 hours with septic shock evolving for less than 24 hours, defined by : o a clinically or microbiologically documented infection and o a SOFA score ≥2 or an increase in SOFA ≥2 points if organ dysfunction was present prior to infection and o the need for vasopressor administration to maintain a mean arterial pressure ≥65mmHg and o lactatemia > 2mmol/L (18mg/dL) despite adequate vascular filling
- •consent of patient, family member or inclusion in emergency situation without prior consent of patient or family member
排除标准
- •Chronic long-term antiepileptic treatment upon admission or patient with uncontrolled seizures
- •Nursing mothers
- •Patient under guardianship or trusteeship
- •Patient with moderate to severe dementia
- •Patient with psychiatric history and/or suicide attempts
- •Patient presenting a prolonged QTc interval on ECG and/or at risk of cardiovascular disease
- •Concomitant treatment with Methotrexate during the administration of the investigational treatment
- •Patients Not affiliated to a social security scheme or CMU
- •Patientswho Participate in another interventional trial with a drug that could interact with levetiracetam or have an impact on the evaluation of the KiSS trial endpoints. In case of doubt, please contact the trial coordinating investigator.
- •Patients with Chronic or progressive central neurological pathologies of traumatic, inflammatory, vascular, infectious, neoplastic or degenerative origin, defined by cognitive impairment not allowing independent living or an IQCODE score > 4.5
- •Patients with Severe head injury less than 3 months old
- •Patients in a situation where active therapies are limited, or for whom the therapeutic commitment is not maximal
- •Patients with Allergy to levetiracetam
- •Minor patients
- •Patients with Pregnancy in progress (bHCG blood or urine)
结局指标
主要结局
The primary endpoint of the KiSS study will be the number of days alive without delirium or coma at D14 following randomization.
The primary endpoint of the KiSS study will be the number of days alive without delirium or coma at D14 following randomization.
次要结局
- Mortality in intensive care, in hospital, at D28 and D90
- Overall survival at D90
- The number of days without mechanical ventilation at D28: the duration between the start and end of mechanical ventilation including invasive, non-invasive mechanical ventilation and high-flow oxygen therapy of the Optiflow™ type (Fisher &. Paykel, Courtabœuf, France). The use of non-invasive ventilation or CPAP for the treatment of sleep apnea or chronic obstructive or restrictive respiratory insufficiency are not taken into account. Translated with DeepL.com (free version)
- Number of days alive outside the intensive care unit at D28 and outside the hospital at D90
- Cumulative incidence and type of epileptic seizures between D1 and D14
- The time between cessation of sedation and awakening
- Severity of cognitive impairment at D90
- Severity of anxiety and depression at D90
- Presence of post-traumatic stress at J90
- Health-related quality of life at D90
- Autonomy in daily life at D90
研究者
Dr Shidasp SIAMI
Scientific
Assistance Publique Hopitaux De Paris
研究点 (9)
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