Condition category
Injury, Occupational Diseases, Poisoning
Date applied
15/01/2009
Date assigned
16/01/2009
Last edited
21/03/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.sactrc.org/

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

Results - basic reporting

Publication summary

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20587052

Publication citations

  1. 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.

Additional files

Editorial Notes