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Open Access Study protocol

Fructose-1, 6-diphosphate (FDP) as a novel antidote for yellow oleander-induced cardiac toxicity: A randomized controlled double blind study

Indika Gawarammana1, Fahim Mohamed1*, Steven J Bowe2, Ashoka Rathnathilake3, Shantha K Narangoda3, Shifa Azher3, Andrew H Dawson1 and Nick A Buckley14

Author Affiliations

1 South Asian Clinical Toxicology Research Collaboration, Department of Clinical Medicine, University of Peradeniya, Sri Lanka

2 Centre for Clinical Epidemiology and Biostatistics, University of Newcastle, NSW, Australia

3 Kurunegala Teaching Hospital, Kurunegala, North Western Province, Sri Lanka

4 Medical Professorial Unit, POW Hospital Clinical School, University of NSW, Australia

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BMC Emergency Medicine 2010, 10:15  doi:10.1186/1471-227X-10-15

Published: 29 June 2010

Abstract

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.

Method/design

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.

Discussion

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.

Trial Registration

Current Controlled trial ISRCTN71018309