Refractory status epilepticus (RSE) patient
Conditions
Interventions
200 mg oral micronized progesterone,
soft gelatin capsules was combined with 10 mL olive oil then administerd via enteric feeding every 8 hours for 5 days as add-
on therapy from usual treatment.
Active Comparator Drug
Sponsors
Phramongkutklao Hospital
Faculty of Pharmacy Silpakorn University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adults, age 18–80 years old 2. Diagnosed with either convulsive or non-convulsive RSE 3. Receiving standard AED treatment, including intravenous midazolam, for longer than 60 minutes
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Serious medical problems; renal failure on dialysis, metastatic cancer, active thromboembolism, active bleeding, elevated transaminase enzymes ≥ five times of normal value (> 160 U/L), blood pressure lower than 80/50 mmHg 3. Absolute NPO (as the studied drug was an enteric tubal formulation) 4. Receiving drugs with potential major interaction with progesterone (e.g. estrogen, edoxaban, and venetoclax)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of the first RSE termination 5 days EEGs | — |
Secondary
| Measure | Time frame |
|---|---|
| hospital and ICU stays hospital stay duration,Mortality rate hospital stay mortality rate and in-hospital mortality rate compared with RSE control patients,Midazolam dose termination of RSE of 5 days elapsed total dose of midazolam,safety hospital stay vital signs, clinical adverse events, abnormal laboratories values | — |
Contacts
Public ContactJuthathip Suphanklang
Silpakorn university
Outcome results
None listed