KISS Evaluation of early administration of Levetiracetam in the prevention and treatment of delirium during septic shock: a randomized, double-blind, placebo-controlled trial.

Conditions

Adult ICU patients with septic shock

Brief summary

The primary endpoint of the KiSS study will be the number of days alive without delirium or coma at D14 following randomization.

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGSODIUM CHLORIDE

DRUGLEVETIRACETAM VIATRIS 100 mg/ml

DRUGsolution à diluer pour perfusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the KiSS study will be the number of days alive without delirium or coma at D14 following randomization.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

France

Outcome results

None listed