Contact information
Type
Scientific
Contact name
Dr Andrew Hamilton Dawson
ORCID ID
Contact details
South Asian Clinical Toxicology Research Collaboration (SACTRC)
Department of Medicine
University of Peradeniya
Peradeniya
20000
Sri Lanka
+94 (0)81 238 4556
adawson@sactrc.org
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
071669
Study information
Scientific title
Is clonidine an effective treatment in organophosphate pesticide poisoning? A phase II randomised controlled trial
Acronym
SACTRC
Study hypothesis
What is the safe and effective clonidine regimen in Organophosphate (OP) poisoning that will:
1. Reduce mortality and/or the need for ventilation
2. Provide moderate sedation
3. Not cause symptomatic adverse effects on blood pressure
Ethics approval(s)
Sri Lankan Medical Association Ethics Review Board approved on 5th August 2005 (ref:
ERC/05-008)
Study design
Phase II multicentre dose-finding study
Primary study design
Interventional
Secondary study design
Multi-centre
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Organophosphate poisoning
Intervention
Four dose levels of clonidine will be studied with the dose increased if the results in the preceding sixteen patients do not indicate any concerning dose-related adverse effects. Four patients will receive placebo and twelve patients will receive active treatment at each dose level. 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, atropinisation and the use of pralidoxime (typically one gram every six hours). 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
Phase II
Drug/device/biological/vaccine name(s)
Clonidine
Primary outcome measure
The primary outcome will be the number of patients requiring ventilation or dying in those receiving clonidine versus the placebo group.
Secondary outcome measures
Secondary outcomes will include:
1. Need for ventilation
2. Blood pressure
3. Level of consciousness
4. Duration of atropine therapy
5. Death
6. Adverse events reported by doctors will be rated by them as to the likelihood of them being due to Clonidine bolus or infusion (certain, probable, possible, unlikely)
Overall study start date
18/05/2006
Overall study end date
03/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients (male or female, aged 16 years or older) with symptomatic acute OP poisoning.
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
64 (recruitment ends on 03/03/2008)
Participant exclusion criteria
1. Patients who do not consent
2. Pregnant women
3. Patients less than 16 years of age
4. Patients who are hypotensive (blood pressure less than 90/50 mmHg) on presentation
5. Patients who have ingested other substances in addition to OP
6. Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure)
Recruitment start date
18/05/2006
Recruitment end date
03/03/2008
Locations
Countries of recruitment
Sri Lanka
Study participating centre
South Asian Clinical Toxicology Research Collaboration (SACTRC)
Peradeniya
20000
Sri Lanka
Sponsor information
Organisation
South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)
Sponsor details
Department of Medicine
University of Peradeniya
Peradeniya
20000
Sri Lanka
+94 (0)81 238 4556
adawson@sactrc.org
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 071669)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|