Contact information
Type
Scientific
Primary contact
Dr Indika Gawarammana
ORCID ID
Contact details
SACTRC
Faculty of Medicine
University of Peradeniya
Peradeniya
20400
Sri Lanka
+94 (0)81 447 9822
indika@sactrc.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
071669
Study information
Scientific title
Fructose-1, 6-diphosphate (FDP) as a novel antidote for yellow oleander-induced cardiac toxicity: a randomised controlled double-blind study
Acronym
Study hypothesis
That adding fructose-1, 6-diphosphate (FDP) to routine treatment will reverse serious arrhythmias in oleander poisoning.
Ethics approval
University of Peradeniya, Sri Lanka gave approval on the 24th September 2008 (ref: 2008/ec/48)
Study design
Double-blind randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiac toxicity from oleander self-poisoning
Intervention
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 receive placebo). The random allocation is concealed and random sequences are generated by specially designed computer program.
All patients will continue to receive standard treatment. This standard treatment is determined by the attending physician who maintains clinical responsibility for all patients. While there may be some minor variation between hospitals current care consists of patient resuscitation, gastrointestinal decontamination when indicated, and atropinisation. All treatment is recorded by the research team. This intervention represents an added treatment to the existing standard of care.
Intervention type
Drug
Phase
Not Specified
Drug names
Fructose-1, 6-diphosphate (FDP)
Primary outcome measure
Reversion to sustained sinus rhythm with a heart rate greater than 50/minute within 2 hours of completion of bolus.
Secondary outcome measures
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)
Overall trial start date
01/02/2009
Overall trial end date
20/02/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
240
Participant 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
Recruitment start date
01/02/2009
Recruitment end date
20/02/2011
Locations
Countries of recruitment
Sri Lanka
Trial participating centre
SACTRC
Peradeniya
20400
Sri Lanka
Sponsor information
Organisation
South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)
Sponsor details
Faculty of Medicine
University of Peradeniya
Peradeniya
20400
Sri Lanka
+94 (0)81 447 9822
enquiry@sactrc.org
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
International Collaborative Research Grant:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Wellcome Trust (UK) (grant ref: 071669)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Health and Medical Research Council (NHMRC) (Australia)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Australia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20587052
Publication citations
-
Protocol
Gawarammana I, Mohamed F, Bowe SJ, Rathnathilake A, Narangoda SK, Azher S, Dawson AH, Buckley NA, Fructose-1, 6-diphosphate (FDP) as a novel antidote for yellow oleander-induced cardiac toxicity: a randomized controlled double blind study., BMC Emerg Med, 2010, 10, 15, doi: 10.1186/1471-227X-10-15.