Fructose-1,6-diphosphate (FDP) in yellow oleander poisoning

Completed

• Conditions: Yellow oleander-induced cardiac toxicity; Injury, Occupational Diseases, Poisoning; Cardiac toxicity

• Registration Number: ISRCTN80882762
• Lead Sponsor: South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Patients (16 years of age and older, male or female) with significant cardiotoxicity will be recruited to this study, i.e. those with: 3° heart block, Mobitz type II 2° block, atrial tachyarrhythmias, sinus bradycardia with heart rate less than 35 bpm, or sinus arrest or block with sinus pauses more than 3 seconds.

Exclusion Criteria

1. No consent
2. Pregnant
3. Less than 16 years of age
4. Ingested other cardioactive substances in addition to oleander
5. Other major medical conditions (e.g. cardiovascular disease renal or hepatic failure)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the time to revert to continuous sinus rhythm with rate more than 44/min, in those receiving FDP versus the placebo group.

Secondary Outcome Measures

Name	Time	Method
1. The number of patients with sinus rhythm with rate more than 44 bpm at two hours<br>2. Number of patients administered DigiFab<br>3. Other adverse events<br>4. Death<br><br>Secondary analysis will also compare the results at each dosing level as well as comparing trends with dose. Adverse events reported by doctors will be rated by them as to the likelihood of them being due to FDP infusion (certain, probable, possible, unlikely).