Yellow oleander-induced cardiac toxicity Injury, Occupational Diseases, Poisoning Cardiac toxicity
Conditions
Interventions
A blood sample will be taken on all randomised patients at the start and end of the infusion and 30 minutes, four and 12 hours later and then at daily intervals. Serum potassium, magnesium, calcium, a
Sponsors
South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (16 years of age and older, male or female) with significant cardiotoxicity will be recruited to this study, i.e. those with: 3° heart block, Mobitz type II 2° block, atrial tachyarrhythmias, sinus bradycardia with heart rate less than 35 bpm, or sinus arrest or block with sinus pauses more than 3 seconds.
Exclusion criteria
Exclusion criteria: 1. No consent 2. Pregnant 3. Less than 16 years of age 4. Ingested other cardioactive substances in addition to oleander 5. Other major medical conditions (e.g. cardiovascular disease renal or hepatic failure)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. The number of patients with sinus rhythm with rate more than 44 bpm at two hours 2. Number of patients administered DigiFab 3. Other adverse events 4. Death Secondary analysis will also compare the results at each dosing level as well as comparing trends with dose. Adverse events reported by doctors will be rated by them as to the likelihood of them being due to FDP infusion (certain, probable, possible, unlikely). | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the time to revert to continuous sinus rhythm with rate more than 44/min, in those receiving FDP versus the placebo group. | — |
Countries
Sri Lanka
Outcome results
None listed