Organophosphate PoisoningPhase 2/3NCT02147054
A Pilot Study Using Rocuronium to Prevent Intermediate Syndrome After Organophosphorus Insecticide Poisoning
A Phase 2/3 study testing Rocuronium and Sugammadex in people with Organophosphate Poisoning, run by University of Edinburgh at 1 site in Sri Lanka.
Trial summary
Organophosphate pesticide poisoning causes close to 300 000 deaths per year worldwide. Many patients who ingest organophosphates require ventilation; of these patients approximately 50% die. Much of the mortality in these ventilated patients is secondary to intermediate syndrome. Read more about this study
- Who is it for?
- Ages 17 to 100 years
- Conditions the study is for
- Organophosphate Poisoning
- What is being tested?
- Rocuronium and Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSri Lanka
- Study dates
- May 2014to Jul 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female
- Age over 16
- Clinical diagnosis of OP insecticide poisoning
- Admission to Intensive Care Unit for Ventilation
- Informed consent from family
- Train of four measurement > 50%
Who cannot join
- Age 16 or under
- Pregnant
- Consent not obtained from patient or patient's family
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study - Assessing the Impact of Using a Neuromuscular Blocking Agent to Reduce Neuromuscular Junction Damage and Intermediate Syndrome in Organophosphorus (OP) Insecticide Poisoned Patients Requiring Ventilation
Organophosphate pesticide poisoning causes close to 300 000 deaths per year worldwide. Many patients who ingest organophosphates require ventilation; of these patients approximately 50% die. Much of the mortality in these ventilated patients is secondary to intermediate syndrome. This is because OP pesticides inhibit acetylcholinesterase, causing an excess of acetylcholine at nerve synapses and the neuromuscular junction (NMJ). At the NMJ, the excess acetylcholine causes overstimulation and damage, which may lead to sudden respiratory arrest or prolonged ventilation and its associated complications.
The investigators believe that blocking these receptors using a neuromuscular blocking agent such as Rocuronium will protect the NMJ from damage and thus prevent intermediate syndrome and reduce number of intubated days and mortality.
In this pilot randomised controlled trial Rocuronium, a competitive nicotinic receptor antagonist, will be used to bind to the receptor at the neuromuscular junction and to block the effects of the accumulated acetylcholine. The effects of OP pesticide on cholinesterase in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is eliminated from the body.
Read the detailed description
Primary outcome: Number of days intubated
- Conditions
- Organophosphate Poisoning
- Being tested
- Rocuronium, Sugammadex
- Keywords
- Organophosphate poisoning, Intermediate syndrome, Rocuronium
- Medical subject headings
- Organophosphate Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called Esmeron
SugammadexDrug
Also called Bridion
Effect of Rocuronium will be reversed at the appropriate time using Sugammadex 16mg/kg as a single dose which may be repeated once.
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium with >95% inhibition | Active comparator | IV Rocuronium to be given:
* Bolus dose of Rocuronium 0.3 mg/kg to achieve >95% inhibition as indicated by Train of Four monitoring
* Continuous infusion of 1.5 mg/kg/hr to maintain level of inhibition
* To continue until two rises in butyrylcholinesterase seen or for a maximum of 5 days Receives: Drug: Rocuronium; Drug: Sugammadex |
| Rocuronium with 50% inhibition | Active comparator | IV Rocuronium to be given:
* Bolus dose of Rocuronium 0.3 mg/kg to achieve 50% inhibition as indicated by Train of Four monitoring
* Continuous infusion of 1.5 mg/kg/hr to maintain level of inhibition
* To continue until two rises in butyrylcholinesterase seen or for a maximum of 5 days Receives: Drug: Rocuronium; Drug: Sugammadex |
| No Rocuronium | No intervention | No Rocuronium will be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intubated days
Measured: Upto 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organophosphate PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Peradeniya
- Responsible party
- Sponsor
- Investigators
- Indika Gawarammana, MD FRCPE PhD, Principal investigator, South Asian Clinical Toxicology Research CollaborationMichael Eddleston, MA PhD FRCP, Study director, University of EdinburghVasanti Pinto, MD FRCA FCARSCI, Study director, University of PeradeniyaVajira Weerasinghe, BDS MPhil PhD, Study director, University of Peradeniya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147054
- Sponsor's protocol ID
- Rocuronium Pilot May 14
- Status last verified
- Oct 2016
- First submitted
- 21 May 2014
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study - Assessing the Impact of Using a Neuromuscular Blocking Agent to Reduce Neuromuscular Junction Damage and Intermediate Syndrome in Organophosphorus (OP) Insecticide Poisoned Patients Requiring Ventilation
- ClinicalTrials.gov ID
- NCT02147054
- Acronym / sponsor ID
- Rocuronium Pilot May 14
- Conditions
- Organophosphate Poisoning
- Keywords
- Organophosphate poisoning, Intermediate syndrome, Rocuronium
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- University of Peradeniya
- Study start
- May 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Organophosphate pesticide poisoning causes close to 300 000 deaths per year worldwide. Many patients who ingest organophosphates require ventilation; of these patients approximately 50% die. Much of the mortality in these ventilated patients is secondary to intermediate syndrome. This is because OP pesticides inhibit acetylcholinesterase, causing an excess of acetylcholine at nerve synapses and the neuromuscular junction (NMJ). At the NMJ, the excess acetylcholine causes overstimulation and damage, which may lead to sudden respiratory arrest or prolonged ventilation and its associated complications.
The investigators believe that blocking these receptors using a neuromuscular blocking agent such as Rocuronium will protect the NMJ from damage and thus prevent intermediate syndrome and reduce number of intubated days and mortality.
In this pilot randomised controlled trial Rocuronium, a competitive nicotinic receptor antagonist, will be used to bind to the receptor at the neuromuscular junction and to block the effects of the accumulated acetylcholine. The effects of OP pesticide on cholinesterase in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is eliminated from the body.
Detailed description
Primary outcome: Number of days intubated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rocuronium with >95% inhibition | Active comparator | Drug: Rocuronium, Drug: SugammadexIV Rocuronium to be given: * Bolus dose of Rocuronium 0.3 mg/kg to achieve >95% inhibition as indicated by Train of Four monitoring * Continuous infusion of 1.5 mg/kg/hr to maintain level of inhibition * To continue until two rises in butyrylcholinesterase seen or for a maximum of 5 days |
| Rocuronium with 50% inhibition | Active comparator | Drug: Rocuronium, Drug: SugammadexIV Rocuronium to be given: * Bolus dose of Rocuronium 0.3 mg/kg to achieve 50% inhibition as indicated by Train of Four monitoring * Continuous infusion of 1.5 mg/kg/hr to maintain level of inhibition * To continue until two rises in butyrylcholinesterase seen or for a maximum of 5 days |
| No Rocuronium | No intervention | –No Rocuronium will be given |
Who may qualify
- Ages
- 17 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female
- Age over 16
- Clinical diagnosis of OP insecticide poisoning
- Admission to Intensive Care Unit for Ventilation
- Informed consent from family
Key exclusion criteria (3 listed)
- Age 16 or under
- Pregnant
- Consent not obtained from patient or patient's family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RocuroniumAlso: Esmeron | Drug | Rocuronium with 50% inhibition, Rocuronium with >95% inhibition |
| SugammadexAlso: BridionEffect of Rocuronium will be reversed at the appropriate time using Sugammadex 16mg/kg as a single dose which may be repeated once. | Drug | Rocuronium with 50% inhibition, Rocuronium with >95% inhibition |
Primary outcome
Number of intubated days
Time frame: Upto 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Indika Gawarammana, MD FRCPE PhD principal investigator
South Asian Clinical Toxicology Research Collaboration
Michael Eddleston, MA PhD FRCP study director
University of Edinburgh
Vasanti Pinto, MD FRCA FCARSCI study director
University of Peradeniya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rocuronium and Sugammadex in people with Organophosphate Poisoning, run by University of Edinburgh at 1 site in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of intubated days (time frame: Upto 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2016.