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

BMC Emergency Medicine

Study Protocol

Steven J Bowe¹  Ashoka Rathnathilake²  Shifa Azher²  Shantha K Narangoda²  Fahim Mohamed³  Indika Gawarammana³  Andrew H Dawson³  Nick A Buckley⁴ 

[1] Centre for Clinical Epidemiology and Biostatistics, University of Newcastle, NSW, Australia;Kurunegala Teaching Hospital, Kurunegala, North Western Province, Sri Lanka;South Asian Clinical Toxicology Research Collaboration, Department of Clinical Medicine, University of Peradeniya, Sri Lanka;South Asian Clinical Toxicology Research Collaboration, Department of Clinical Medicine, University of Peradeniya, Sri Lanka;Medical Professorial Unit, POW Hospital Clinical School, University of NSW, Australia;

关键词: Sinus Rhythm;    Activate Charcoal;    Cardiac Glycoside;    South Asian Country;    Holter Monitor;   

DOI  :  10.1186/1471-227X-10-15

 received in 2009-11-02, accepted in 2010-06-29,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundCardiac 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/designWe 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.DiscussionThis 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 RegistrationCurrent Controlled trial ISRCTN71018309

【 授权许可】

Unknown   
© Gawarammana et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.