Intrathecal Immunoglobulin for Treatment of Adult Patients With Tetanus: a Randomized Controlled 2x2 Factorial Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Requirement for mechanical ventilation during ICU stay
研究概览
简要总结
To establish whether the addition of intrathecal tetanus antitoxin reduces the need for mechanical ventilation in patients with tetanus
详细描述
The investigators will conduct a randomised partially-blinded controlled 2x2 factorial trial. First, adults admitted to the Intensive Care Unit at the Hospital for Tropical Diseases Ho Chi Minh City will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin. Second, participants will be randomized to receive either standard treatment with intramuscular antitoxin alone or with the addition of 500 IU intrathecal human antitoxin. Patients with prior antitoxin treatment and those with contra-indications to lumbar puncture or antitoxin treatment will be excluded.
All patients will receive other standard tetanus treatment as deemed necessary by the attending physicians. Spasms will be treated with benzodiazepines as first-line therapy. Patients with spasms not controlled with benzodiazepines will receive tracheostomy, paralysis, magnesium sulphate and mechanical ventilation. Heart rate, BP, temperature and daily drug use will be recorded throughout the ICU stay. Patients will be followed following discharge from hospital until 240 days for disability/ death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (≥16 years old) with a clinical diagnosis of generalized tetanus admitted to the intensive care unit (ICU) at the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
排除标准
- •Prior administration of antitoxin during this episode
- •Contra-indication to use of human or equine antitoxin
- •Contra-indication to lumbar puncture
- •Already receiving mechanical ventilation or expected to require this before intrathecal injection can be given
- •Pregnancy
- •Informed consent not obtained
研究组 & 干预措施
Intramuscular antitoxin
Human tetanus immunoglobulin (Tetagam-P): Injection (prefilled syringe) 250 IU in 1 ml - Intramuscular 3000 IU OR Equine antiserum - 21,000 units
干预措施: Intramuscular antitoxin (Procedure)
Intramuscular antitoxin
Human tetanus immunoglobulin (Tetagam-P): Injection (prefilled syringe) 250 IU in 1 ml - Intramuscular 3000 IU OR Equine antiserum - 21,000 units
干预措施: Human tetanus immunoglobulin (Procedure)
Human tetanus immunoglobulin
Human tetanus immunoglobulin (Tetagam-P): Injection (prefilled syringe) 250 IU in 1 ml - Intrathecal 500 IU
干预措施: Human tetanus immunoglobulin (Procedure)
结局指标
主要结局
Requirement for mechanical ventilation during ICU stay
时间窗: During ICU stay, an average of 3 weeks
Criteria for mechanical ventilation are oxygen saturation (SpO2) \<90%; or partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) \<250; or excessive spasms necessitating muscle paralysis. These criteria are intended as a guide and the final decision to ventilate a patient rests with the individual doctor responsible for the patient.
次要结局
- Duration of ICU stay(During ICU stay, an average of 3 weeks)
- Duration of hospital stay(During hospital stay, an average of 5 weeks)
- Duration of mechanical ventilation(During hospital stay, an average of 5 weeks)
- In hospital and 240 day mortality(240 days)
- In hospital and 240 day disability(240 days)
- New antibiotic prescription during ICU stay(During ICU stay, an average of 3 weeks)
- Incidence of Ventilator Associated Pneumonia(During hospital stay, an average of 5 weeks)
- Incidence of clinical syndrome of autonomic nervous system dysfunction(240 days)
- Total dose of benzodiazepines and pipecuronium during hospital stay(During hospital stay, an average of 5 weeks)
- Incidence of adverse events(During hospital stay, an average of 5 weeks)