drugset / Trial / NCT03564574

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

NCT03564574

Non-randomizedParallel-groupOpen-labelSupportive care

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.

Timeline

Start
2015-09
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Lipid Emulsion Unknown 20 % Intravenous
Subject Lipid Emulsion Unknown 100 ml Intravenous