Fructose-1, 6-diphosphate (FDP) as a novel antidote for yellow oleander-induced cardiac toxicity: a randomized controlled double blind study.
BACKGROUND
Cardiac toxicity due to ingestion of oleander plant seeds in Sri Lanka and some other South Asian countries is very common. At present symptomatic oleander seed poisoning carries a mortality of 10% in Sri Lanka and treatment of yellow oleander poisoning is limited to gastric decontamination and atropine administration. The only proven effective antidote is digoxin antibodies but these are not available for routine use because of the high cost. The main objective of this study is to investigate the effectiveness of a new and inexpensive antidote for patients with life threatening arrhythmias due oleander poisoning.


METHODS
We set up a randomised double blind clinical trial to assess the effectiveness of Fructose 1, 6 diphosphate (FDP) in acute yellow oleander poisoning patients admitted to the adult medical wards of a tertiary hospital in Sri Lanka. Patients will be initially resuscitated following the national guidelines and eligible patients will be randomised to receive either FDP or an equal amount of normal saline. The primary outcome measure for this study is the sustained reversion to sinus rhythm with a heart rate greater than 50/min within 2 hours of completion of FDP/placebo bolus. Secondary outcomes include death, reversal of hyperkalaemia on the 6, 12, 18 and 24 hour samples and maintenance of sinus rhythm on the holter monitor. Analysis will be on intention-to-treat.


CONCLUSIONS
This trial will provide information on the effectiveness of FDP in yellow oleander poisoning. If FDP is effective in cardiac glycoside toxicity, it would provide substantial benefit to the patients in rural Asia. The drug is inexpensive and thus could be made available at primary care hospitals if proven to be effective.


BACKGROUND
Current Controlled trial ISRCTN71018309.
Gawarammana
Indika
I
South Asian Clinical Toxicology Research Collaboration, Department of Clinical Medicine, University of Peradeniya, Sri Lanka.
Mohamed
Fahim
F
Bowe
Steven J
SJ
Rathnathilake
Ashoka
A
Narangoda
Shantha K
SK
Azher
Shifa
S
Dawson
Andrew H
AH
Buckley
Nick A
NA
D000328:Adult; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D000931:Antidotes / Q000627:therapeutic use; D001145:Arrhythmias, Cardiac / Q000139:chemically induced* / Q000188:drug therapy*; D004636:Emergency Service, Hospital / Q000458:organization & administration; D005260:Female; D005635:Fructosediphosphates / Q000627:therapeutic use*; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D008297:Male; D010939:Plant Poisoning / Q000150:complications / Q000188:drug therapy*; D012151:Resuscitation; D013188:Sri Lanka; D031052:Thevetia / Q000506:poisoning*; D016896:Treatment Outcome; D014883:Water-Electrolyte Imbalance / Q000139:chemically induced / Q000628:therapy
D000889:Anti-Arrhythmia Agents; D000931:Antidotes; D005635:Fructosediphosphates; C029063:fructose-1,6-diphosphate