跳至主要内容
临床试验/NCT03564574
NCT03564574已完成4 期

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

Post Graduate Institute of Medical Education and Research, Chandigarh2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Significant change in pulse from baseline to 72 hours after admission

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Significant change in pulse from baseline to 72 hours after admission

时间窗: 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

时间窗: 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

时间窗: Date of admission up to 72 hours

Change in arterial oxygen saturation (SpO2) in percentage

Significant change in mean arterial pressure from baseline to 72 hours after admission

时间窗: 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

Adverse effects

时间窗: 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

时间窗: 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

次要结局

  • Effect on case fatality and morbidity(Admission to the hospital till time of discharge up to 1 month)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bharath A. Chhabria

Doctor

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (2)

Loading locations...

相似试验