A trial of fructose-di-phosphate treatment in oleander poisoning

ISRCTN ISRCTN71018309
DOI https://doi.org/10.1186/ISRCTN71018309
Secondary identifying numbers 071669
Submission date
15/01/2009
Registration date
16/01/2009
Last edited
21/03/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Indika Gawarammana
Scientific

SACTRC
Faculty of Medicine
University of Peradeniya
Peradeniya
20400
Sri Lanka

Phone +94 (0)81 447 9822
Email indika@sactrc.org

Study information

Study designDouble-blind randomised placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleFructose-1, 6-diphosphate (FDP) as a novel antidote for yellow oleander-induced cardiac toxicity: a randomised controlled double-blind study
Study objectivesThat adding fructose-1, 6-diphosphate (FDP) to routine treatment will reverse serious arrhythmias in oleander poisoning.
Ethics approval(s)University of Peradeniya, Sri Lanka gave approval on the 24th September 2008 (ref: 2008/ec/48)
Health condition(s) or problem(s) studiedCardiac toxicity from oleander self-poisoning
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Fructose-1, 6-diphosphate (FDP)
Primary outcome measureReversion to sustained sinus rhythm with a heart rate greater than 50/minute within 2 hours of completion of bolus.
Secondary outcome measures1. 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 study start date01/02/2009
Completion date20/02/2011

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants240
Key inclusion criteriaPatients (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
Key exclusion criteria1. 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
Date of first enrolment01/02/2009
Date of final enrolment20/02/2011

Locations

Countries of recruitment

  • Sri Lanka

Study participating centre

SACTRC
Peradeniya
20400
Sri Lanka

Sponsor information

South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)
Research organisation

Faculty of Medicine
University of Peradeniya
Peradeniya
20400
Sri Lanka

Phone +94 (0)81 447 9822
Email enquiry@sactrc.org
Website http://www.sactrc.org/
ROR logo "ROR" https://ror.org/04z435g27

Funders

Funder type

Charity

International Collaborative Research Grant:

No information available

The Wellcome Trust (UK) (grant ref: 071669)

No information available

National Health and Medical Research Council (NHMRC) (Australia)
Government organisation / National government
Alternative name(s)
NHMRC
Location
Australia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 29/06/2010 Yes No