Cardiac toxicity from oleander self-poisoning Injury, Occupational Diseases, Poisoning Toxic effect of other noxious substances eaten as food
Conditions
Interventions
Patients will be randomised to FDP (250 mg/kg loading dose over 20 minutes followed by 6 mg/kg/hr for 24 hours) or a placebo in a 1:1 ratio (i.e 120 patients will receive FDP and 120 patients will rec
Sponsors
South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (greater than 12 years of age, both sexes) with any of the following manifestations of oleander-induced cardiac toxicity: 1. Second degree heart block 2. Third degree heart block 3. Bradycardia with a heart rate of less than 40 beats/minute 4. Any rhythm with a systolic blood pressure below 80 mmHg
Exclusion criteria
Exclusion criteria: 1. Patients with documented ischaemic heart disease or valvular heart disease. These patients may still be eligible for open label compassionate use of FDP. 2. Patients presenting with cardiac arrest on admission. These patients will be eligible for open label compassionate use of FDP. 3. Age less than 12 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reversion to sustained sinus rhythm with a heart rate greater than 50/minute within 2 hours of completion of bolus. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Death 2. Reversal of hyperkalaemia on the 6, 12,18 and 24 hour samples 3. Maintenance of sinus rhythm on the Holter monitor (reflecting the efficacy of the infusion) | — |
Countries
Sri Lanka
Outcome results
None listed