Repurposing flumazenil for intramuscular treatment of coma due to unintentional drug overdose - a dose-finding safety and efficacy phase II/III study

niversity of Edinburgh0 个研究点目标入组 635 人开始时间: 2024年3月8日最近更新: 2024年9月2日

适应症

试验速览

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•1. Acute suspected unintentional BZD overdose presenting to hospital with reduced consciousness after administration of clinically adequate doses of naloxone. Mixed overdoses suspected to include BZDs will be included
•2. Other common causes of reduced consciousness (such as hypoglycaemia) will have been excluded
•3. RASS score of -5 (unrousable) to -3 (moderate sedation)
•4. Aged, or believed to be aged, 16 years and over

•1. RASS score above -3
•2. Past medical history of epilepsy or chronic brain injury
•3. Seizure pre-hospital following the overdose or after hospital admission, before recruitment
•4. Clinically apparent pregnancy or medical record of current pregnancy (urine-HCG test not practicable in patients with reduced consciousness)
•5. Prolonged QRS duration (>120 msec, unless due to pre-existing bundle branch block) on electrocardiogram
•6. Prisoner or under arrest
•7. Currently detained under the Mental Health Act
•8. HIV positive with detectable virus load, or no virus load data from previous 12 months, or not currently on therapy
•9. Patients who have previously participated in the study (according to the recruitment log).
•In Stage 1, as we explore the safety of flumazenil, we will have additional exclusion criteria to further reduce the risk of seizures.
•10. No access to medical records at recruitment
•11. Unknown patient (precluding use of medical records).
•To ensure external validity for future clinical practice, when medical records will usually not be immediately available, these will not be used once stage 1 has identified potentially safe doses. The risk of seizures in these patients with a dose found to be safe in Stage 1 is likely to be outweighed by the chance of benefit if used pre-hospital in future.

发起方

niversity of Edinburgh