To Study the Effects of Lipid Emulsion on Hemodynamics in Organophosphate Compound Poisoning

NCT03564574 | Completed Phase 4

• 1 other identifier: bharath_thesis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Organophosphate Poisoning

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  Date of admission up to 72 hours

• Adverse effects

  Incidence of adverse reactions in percentage

  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

  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

  Date of admission up to 72 hours

Secondary Outcomes (1)

• Effect on case fatality and morbidity

  Admission to the hospital till time of discharge up to 1 month

Study Arms (2)

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

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.

Interventions

Lipid Emulsion COMBINATION_PRODUCT

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.

Also known as: Intralipid 20 percent

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of consumption of OP compound.
• Symptom complex consistent with OP poisoning
• Age \> 18 years
• Informed consent from the patient or next kin.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Pgimer

Chandigarh, 160012, India

Location

Related Publications (1)

• 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.

  PMID: 30307350 DERIVED

MeSH Terms

Conditions

Organophosphate Poisoning

Interventions

Fat Emulsions, Intravenous

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Emulsions; Colloids; Dosage Forms; Pharmaceutical Preparations; Parenteral Nutrition Solutions; Pharmaceutical Solutions; Solutions; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: June 21, 2018
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 21, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)