KETamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest (OHCA) - the KETOHCA Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 282
- 试验地点
- 2
- 主要终点
- Neuron-specific enolase (NSE) measured 48 hours after OHCA
研究概览
简要总结
OHCA is a critical medical emergency with significant mortality and morbidity primarily due to hypoxic-ischemic brain injury (HIBI). Despite advances in resuscitation techniques, the neurological outcomes for survivors remain poor. Current post-resuscitation practices lack specific neuroprotective strategies. Ketamine, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, has shown potential neuroprotective properties in preclinical and clinical studies due to its ability to inhibit excitotoxicity and reduce neuronal apoptosis. This trial hypothesizes that ketamine, when used for sedation in OHCA patients, may offer superior neuroprotective benefits compared to the commonly used sedative propofol. By comparing the effects of ketamine and propofol on neuronal damage markers and long-term neurological outcomes, this study aims to identify a potentially effective intervention to improve the prognosis of OHCA patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age ≥18 years) AND
- •resuscitated OHCA of presumed cardiac cause with a shockable first recorded heart rhythm AND
- •mean arterial pressure (MAP) >40 mmHg AND
- •a decision to perform prehospital intubation.
排除标准
- •Advanced life support termination-of-resuscitation (TOR) criteria met
- •Systolic blood pressure >190 mmHg
- •Known allergy to ketamine or propofol
- •Chronic diseases making 180-day survival unlikely
- •Body temperature <30° C.
研究组 & 干预措施
S-ketamin
Intravenous or intraosseous bolus administration at a minimum of 0.5 mg/kg of esketamine
干预措施: esketamine hydrochloride (Drug)
Propofol
Prehospital intravenous or intraosseous bolus administration of a minimum dose of 0.25 mg/kg propofol
干预措施: propofol (Drug)
结局指标
主要结局
Neuron-specific enolase (NSE) measured 48 hours after OHCA
时间窗: 48 hours after OHCA
To determine the neuroprotective efficacy of ketamine compared with propofol administered as part of sedation for intubation after initial resuscitation from OHCA
次要结局
- Death from any cause(180 days after cardiac arrest)
- Neurological outcome: modified Rankin Score (mRS)(At 240 days after OHCA.)
- Neurological outcome: Cerebral Performance Categories (CPC)(At 240 days after OHCA.)
研究者
Christian Hassager
Chief Physician
Rigshospitalet, Denmark