Organophosphate PoisoningPhase 4NCT03564574
To Study the Effects of Lipid Emulsion on Hemodynamics in Organophosphate Compound Poisoning
A Phase 4 study testing Lipid Emulsion in people with Organophosphate Poisoning, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
To Study the Effects of Lipid Emulsion on Hemodynamics in Organophosphate Compound Poisoning Objectives: To study the effect of administration of intravenous lipid emulsion on hemodynamic parameters, incidence of adverse effects in patients with organophosphate poisoning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organophosphate Poisoning
- What is being tested?
- Lipid Emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2015to Dec 2016
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of consumption of OP compound.
- Symptom complex consistent with OP poisoning
- Age > 18 years
- Informed consent from the patient or next kin.
Who cannot join
- History of combined poisoning with a non OP compound.
- All other patients not fitting in the organophosphate symptom complex.
- Patients with underlying liver and kidney disease.
- History suggestive of acute pancreatitis in the past.
Trial locations and contacts
1 site in 1 country.
About this study
To Study the Effects of Lipid Emulsion on Hemodynamics in Organophosphate Compound Poisoning Objectives: To study the effect of administration of intravenous lipid emulsion on hemodynamic parameters, incidence of adverse effects in patients with organophosphate poisoning.
Background: Lipid emulsion has been used to revert toxicities of lipophilic drugs, toxins (especially lignocaine) and in critically ill patients. Though the safety has been established, the effect on hemodynamics in Organophosphate (OP) poisoned patients has never been studied. Hence this study is underway to fill those lacunae and evaluate the safety profile of lipid emulsion in organophosphate poisoned patients.
Methodology: The study is a prospective open label pilot study, which is underway at a tertiary care hospital in North India. Patients with history and clinical features of OP poisoning meeting the inclusion and exclusion parameters are being treated according to institutional protocols. Along with routine treatment a single dose of 20% lipid emulsion is being administered on admission to patients after obtaining consent. Patients are being followed up till discharge or death. Hemodynamic parameters and adverse effects following lipid emulsion administration are being studied over various intervals of time.
Read the detailed description
Methods A prospective open label pilot study was conducted with an aim to study the safety and effects of 20% lipid emulsion in OP compound poisoning. The objectives were to study the effects on hemodynamic parameters, the effect on morbidity, mortality and the occurrence of adverse events.
All patients, ≥ 13 years, with history of consumption of OP compound and clinical features of mild, moderate or severe OP compound poisoning as per the Peradeniya score (Table 1), admitted to the emergency department during the study period from September 2015 - December 2016 were included after written informed consent. Consent was obtained from the nearest kin if the presentation was with altered mental state. The recruitment began after approval from the institute's ethics committee.
Patients with chronic liver or kidney disease, history of acute or chronic pancreatitis in the past, those with combined poisoning with non OP compounds and asymptomatic patients were not included.
At presentation, detailed history was sought and subjects were examined for signs and symptoms of OP poisoning. Vital parameters (pulse rate, blood pressure, and respiratory rate) were noted. Blood samples were drawn for assessing baseline electrolytes, renal functions, haematological parameters and serum amylase. All patients received a single dose of 100mL of 20% lipid emulsion as an intra-venous infusion over 1 hour along with routine treatment as per institution protocols. Atropine was administered to patients by doubling dose method, which comprised of administering atropine starting from 2mg and to double the dose and administer till complete atropinization. Following this an infusion of 10-20 percent of the atropinizing dose was given every hour. In view of the controversial role of pralidoxime, it was not included in the study. The cases were followed up until recovery/death.
The patients were under observation for their vital signs, pupil size, fasciculation, respiratory crackles, amount of oral secretions and, if intubated, tracheal secretion. In addition they underwent monitoring of vital parameters every ten minutes during the course of lipid administration for the first thirty minutes followed by every fifteen minutes during the next 2 hours and every 2nd hourly thereafter.
Hemodynamic parameters, haematological, biochemical parameters, adverse effects and outcomes were compared at various intervals of time following administration of lipid emulsion, up to 72 hours, with those at the baseline; hemodynamic parameters were also compared with historic controls.
The primary outcome was to study the change in hemodynamic parameters (pulse rate, systolic blood pressure, mean arterial pressure and respiratory rate) after delivery of lipid emulsion in OP poisoned individuals up to 72 hours and compare any changes in the hemodynamic parameters with that of historic controls.
Secondary outcomes were to study the effects on case fatality (in-hospital until discharge or death), morbidity (duration of hospitalization, duration of mechanical ventilation, dose of atropine given) and the occurrence of complications including those related to lipid emulsion and hospital acquired infections.
- Conditions
- Organophosphate Poisoning
- Being tested
- Lipid Emulsion
- Medical subject headings
- Organophosphate Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid EmulsionCombination product
Also called Intralipid 20 percent
All patients in the 'Study group' received a single dose of 100 ml of 20 percent Lipid emulsion as an infusion over 1 hour along with routine treatment as per institution protocols. Atropine was administered to patients by doubling dose method, which comprised of administering atropine starting from 2mg and to double the dose and administer till complete atropinization. Following this an infusion of 10 percent of the atropinizing dose was given every hour. Patients were evaluated using a standardized clinical interview, physical examination, laboratory tests.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Inclusion criteria
1. History of consumption of OP compound.
2. Symptom complex consistent with OP poisoning
3. Age > 18 years
4. Informed consent from the patient or next kin.
Exclusion criteria
1. History of combined poisoning with a non OP compound.
2. All other patients not fitting in the organophosphate symptom complex.
3. Patients with underlying liver and kidney disease.
4. History suggestive of acute pancreatitis in the past.
All patients with history and clinical features of OP compound poisoning admitted to the emergency department in PGIMER during the study period, meeting the inclusion, exclusion criteria and who gave consent were enrolled in the study.
Intervention : Administration of 100mL of 20% Lipid emulsion to all patients in the study group Receives: Combination Product: Lipid Emulsion |
| Historic controls | No intervention | The control arm The study group was compared with data of patients admitted for OP poisoning between the years 2013 and 2014 ( 2 calendar years), fulfilling the inclusion and exclusion criteria as stated above. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant change in pulse from baseline to 72 hours after admission
The primary outcome was to study the change in
1.Pulse (beats/min) after delivery of lipid emulsion in OP poisoned individuals at various intervals of time from time of admission to 72 hours after administration of lipid emulsion and compare the same data with historic controls
Measured: Date of admission up to 72 hours
Significant change in systolic blood pressure from baseline to 72 hours after admission
The primary outcome was to study the change in 2.Systolic blood pressure (mm Hg) after delivery of lipid emulsion in OP poisoned individuals at various intervals of time from time of admission to 72 hours after administration of lipid emulsion and compare the same data with historic controls
Measured: Date of admission up to 72 hours
Significant change in oxygen arterial saturation from baseline to 72 hours after admission
Change in arterial oxygen saturation (SpO2) in percentage
Measured: Date of admission up to 72 hours
Adverse effects
Incidence of adverse reactions in percentage
Measured: Date of admission until discharge/death of subjects up to 1 month
Significant change in diastolic blood pressure from baseline to 72 hours after admission
The primary outcome was to study the change in 5. Diastolic blood pressure (mm Hg) after delivery of lipid emulsion in OP poisoned individuals at various intervals of time from time of admission to 72 hours after administration of lipid emulsion and compare the same data with historic controls
Measured: Date of admission up to 72 hours
Significant change in mean arterial pressure from baseline to 72 hours after admission
The primary outcome was to study the change in 6. Mean arterial pressure (mm Hg) after delivery of lipid emulsion in OP poisoned individuals at various intervals of time from time of admission to 72 hours after administration of lipid emulsion and compare the same data with historic controls
Measured: Date of admission up to 72 hours
Secondary outcomes (1)
Effect on case fatality and morbidity
Secondary outcomes were to study the effects on
- All cause mortality (in-hospital until discharge or death), that is the case fatality and morbidity in terms of duration of hospitalization in days, duration of mechanical ventilation in days, dose of atropine given in milligram an The data was compared with historic controls
Measured: Admission to the hospital till time of discharge up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study startSep 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bharath A. Chhabria, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564574
- Sponsor's protocol ID
- bharath_thesis
- Status last verified
- Jun 2018
- First submitted
- 3 May 2016
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chhabria BA, Bhalla A, Shafiq N, Kumar S, Dhibar DP, Sharma N. Lipid emulsion for acute organophosphate insecticide poisoning - a pilot observational safety study. Clin Toxicol (Phila). 2019 May;57(5):318-324. doi: 10.1080/15563650.2018.1520997. Epub 2018 Oct 11.
PubMed 30307350
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Effects of Lipid Emulsion on Hemodynamics in Organophosphate Compound Poisoning
- ClinicalTrials.gov ID
- NCT03564574
- Acronym / sponsor ID
- bharath_thesis
- Conditions
- Organophosphate Poisoning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Jun 2018 (actual)
- 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.
To Study the Effects of Lipid Emulsion on Hemodynamics in Organophosphate Compound Poisoning Objectives: To study the effect of administration of intravenous lipid emulsion on hemodynamic parameters, incidence of adverse effects in patients with organophosphate poisoning.
Background: Lipid emulsion has been used to revert toxicities of lipophilic drugs, toxins (especially lignocaine) and in critically ill patients. Though the safety has been established, the effect on hemodynamics in Organophosphate (OP) poisoned patients has never been studied. Hence this study is underway to fill those lacunae and evaluate the safety profile of lipid emulsion in organophosphate poisoned patients.
Methodology: The study is a prospective open label pilot study, which is underway at a tertiary care hospital in North India. Patients with history and clinical features of OP poisoning meeting the inclusion and exclusion parameters are being treated according to institutional protocols. Along with routine treatment a single dose of 20% lipid emulsion is being administered on admission to patients after obtaining consent. Patients are being followed up till discharge or death. Hemodynamic parameters and adverse effects following lipid emulsion administration are being studied over various intervals of time.
Detailed description
Methods A prospective open label pilot study was conducted with an aim to study the safety and effects of 20% lipid emulsion in OP compound poisoning. The objectives were to study the effects on hemodynamic parameters, the effect on morbidity, mortality and the occurrence of adverse events.
All patients, ≥ 13 years, with history of consumption of OP compound and clinical features of mild, moderate or severe OP compound poisoning as per the Peradeniya score (Table 1), admitted to the emergency department during the study period from September 2015 - December 2016 were included after written informed consent. Consent was obtained from the nearest kin if the presentation was with altered mental state. The recruitment began after approval from the institute's ethics committee.
Patients with chronic liver or kidney disease, history of acute or chronic pancreatitis in the past, those with combined poisoning with non OP compounds and asymptomatic patients were not included.
At presentation, detailed history was sought and subjects were examined for signs and symptoms of OP poisoning. Vital parameters (pulse rate, blood pressure, and respiratory rate) were noted. Blood samples were drawn for assessing baseline electrolytes, renal functions, haematological parameters and serum amylase. All patients received a single dose of 100mL of 20% lipid emulsion as an intra-venous infusion over 1 hour along with routine treatment as per institution protocols. Atropine was administered to patients by doubling dose method, which comprised of administering atropine starting from 2mg and to double the dose and administer till complete atropinization. Following this an infusion of 10-20 percent of the atropinizing dose was given every hour. In view of the controversial role of pralidoxime, it was not included in the study. The cases were followed up until recovery/death.
The patients were under observation for their vital signs, pupil size, fasciculation, respiratory crackles, amount of oral secretions and, if intubated, tracheal secretion. In addition they underwent monitoring of vital parameters every ten minutes during the course of lipid administration for the first thirty minutes followed by every fifteen minutes during the next 2 hours and every 2nd hourly thereafter.
Hemodynamic parameters, haematological, biochemical parameters, adverse effects and outcomes were compared at various intervals of time following administration of lipid emulsion, up to 72 hours, with those at the baseline; hemodynamic parameters were also compared with historic controls.
The primary outcome was to study the change in hemodynamic parameters (pulse rate, systolic blood pressure, mean arterial pressure and respiratory rate) after delivery of lipid emulsion in OP poisoned individuals up to 72 hours and compare any changes in the hemodynamic parameters with that of historic controls.
Secondary outcomes were to study the effects on case fatality (in-hospital until discharge or death), morbidity (duration of hospitalization, duration of mechanical ventilation, dose of atropine given) and the occurrence of complications including those related to lipid emulsion and hospital acquired infections.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Combination Product: Lipid EmulsionInclusion criteria 1. History of consumption of OP compound. 2. Symptom complex consistent with OP poisoning 3. Age > 18 years 4. Informed consent from the patient or next kin. Exclusion criteria 1. History of combined poisoning with a non OP compound. 2. All other patients not fitting in the organophosphate symptom complex. 3. Patients with underlying liver and kidney disease. 4. History suggestive of acute pancreatitis in the past. All patients with history and clinical features of OP compound poisoning admitted to the emergency department in PGIMER during the study period, meeting the inclusion, exclusion criteria and who gave consent were enrolled in the study. Intervention : Administration of 100mL of 20% Lipid emulsion to all patients in the study group |
| Historic controls | No intervention | –The control arm The study group was compared with data of patients admitted for OP poisoning between the years 2013 and 2014 ( 2 calendar years), fulfilling the inclusion and exclusion criteria as stated above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of consumption of OP compound.
- Symptom complex consistent with OP poisoning
- Age > 18 years
- Informed consent from the patient or next kin.
Key exclusion criteria (4 listed)
- History of combined poisoning with a non OP compound.
- All other patients not fitting in the organophosphate symptom complex.
- Patients with underlying liver and kidney disease.
- History suggestive of acute pancreatitis in the past.
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 |
|---|---|---|
| Lipid EmulsionAlso: Intralipid 20 percentAll patients in the 'Study group' received a single dose of 100 ml of 20 percent Lipid emulsion as an infusion over 1 hour along with routine treatment as per institution protocols. Atropine was administered to patients by doubling dose method, which comprised of administering atropine starting from 2mg and to double the dose and administer till complete atropinization. Following this an infusion of 10 percent of the atropinizing dose was given every hour. Patients were evaluated using a standardized clinical interview, physical examination, laboratory tests. | Combination product | Study group |
Primary outcome
Significant change in pulse from baseline to 72 hours after admission
Time frame: Date of admission up to 72 hours
The primary outcome was to study the change in 1.Pulse (beats/min) after delivery of lipid emulsion in OP poisoned individuals at various intervals of time from time of admission to 72 hours after administration of lipid emulsion and compare the same data with historic controls
Significant change in systolic blood pressure from baseline to 72 hours after admission
Time frame: Date of admission up to 72 hours
The primary outcome was to study the change in 2.Systolic blood pressure (mm Hg) after delivery of lipid emulsion in OP poisoned individuals at various intervals of time from time of admission to 72 hours after administration of lipid emulsion and compare the same data with historic controls
Significant change in oxygen arterial saturation from baseline to 72 hours after admission
Time frame: Date of admission up to 72 hours
Change in arterial oxygen saturation (SpO2) in percentage
Adverse effects
Time frame: Date of admission until discharge/death of subjects up to 1 month
Incidence of adverse reactions in percentage
Significant change in diastolic blood pressure from baseline to 72 hours after admission
Time frame: Date of admission up to 72 hours
The primary outcome was to study the change in 5. Diastolic blood pressure (mm Hg) after delivery of lipid emulsion in OP poisoned individuals at various intervals of time from time of admission to 72 hours after administration of lipid emulsion and compare the same data with historic controls
Significant change in mean arterial pressure from baseline to 72 hours after admission
Time frame: Date of admission up to 72 hours
The primary outcome was to study the change in 6. Mean arterial pressure (mm Hg) after delivery of lipid emulsion in OP poisoned individuals at various intervals of time from time of admission to 72 hours after administration of lipid emulsion and compare the same data with historic controls
1 secondary outcome
Effect on case fatality and morbidity
Time frame: Admission to the hospital till time of discharge up to 1 month
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 21 Jun 2018.
- Derived from this study: PubMed 30307350Chhabria BA, Bhalla A, Shafiq N, Kumar S, Dhibar DP, Sharma N. Lipid emulsion for acute organophosphate insecticide poisoning - a pilot observational safety study. Clin Toxicol (Phila). 2019 May;57(5):318-324. doi: 10.1080/15563650.2018.1520997. Epub 2018 Oct 11.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lipid Emulsion in people with Organophosphate Poisoning, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 4 inclusion and 4 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 21 Jun 2018. 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 India. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Significant change in pulse from baseline to 72 hours after admission (time frame: Date of admission up to 72 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03564574, which also lists 1 linked publication.
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 21 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.