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
Scientific
SACTRC
Faculty of Medicine
University of Peradeniya
Peradeniya
20400
Sri Lanka
| Phone | +94 (0)81 447 9822 |
|---|---|
| indika@sactrc.org |
Study information
| Study design | Double-blind randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Fructose-1, 6-diphosphate (FDP) as a novel antidote for yellow oleander-induced cardiac toxicity: a randomised controlled double-blind study |
| Study objectives | That 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2009 |
| Completion date | 20/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 240 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2009 |
| Date of final enrolment | 20/02/2011 |
Locations
Countries of recruitment
- Sri Lanka
Study participating centre
SACTRC
Peradeniya
20400
Sri Lanka
20400
Sri Lanka
Sponsor information
South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)
Research organisation
Research organisation
Faculty of Medicine
University of Peradeniya
Peradeniya
20400
Sri Lanka
| Phone | +94 (0)81 447 9822 |
|---|---|
| enquiry@sactrc.org | |
| Website | http://www.sactrc.org/ |
"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
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
