Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/07/2007
Date assigned
20/07/2007
Last edited
26/01/2009
Prospective/Retrospective
Retrospectively 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 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 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

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

Trial setting

Hospitals

Trial 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

Phase

Phase II

Drug names

Clonidine

Primary outcome measures

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 trial start date

18/05/2006

Overall trial end date

03/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients (male or female, aged 16 years or older) with symptomatic acute OP poisoning.

Participant type

Patient

Age group

Adult

Gender

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

Trial 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

http://www.sactrc.org

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes